uracil and Diabetes Mellitus, Type 2 studies

Diabetes Mellitus, Type 2: A subclass of DIABETES MELLITUS that is not INSULIN-responsive or dependent (NIDDM). It is characterized initially by INSULIN RESISTANCE and HYPERINSULINEMIA; and eventually by GLUCOSE INTOLERANCE; HYPERGLYCEMIA; and overt diabetes. Type II diabetes mellitus is no longer considered a disease exclusively found in adults. Patients seldom develop KETOSIS but often exhibit OBESITY.

Research Excerpts

Excerpt	Relevance	Reference
" All participants had a documented history of coronary heart disease or high cardiovascular risk at screening and received aspirin (acetylsalicylic acid) 100 mg daily throughout the trial."	9.51	Efficacy and safety of alogliptin versus acarbose in Chinese type 2 diabetes patients with high cardiovascular risk or coronary heart disease treated with aspirin and inadequately controlled with metformin monotherapy or drug-naive: A multicentre, randomi ( Gao, B; Gao, W; Ji, Q; Wan, H; Xu, F; Zhang, X; Zhou, R, 2022)
" The aim of the study was to evaluate whether dipeptidyl peptidase-4 (DPP-4) inhibitor alogliptin (ALO) alone or in combination with pioglitazone (PIO) improves β-cell function along with insulin resistance (IR) in metformin (MET) treated obese women with PCOS with persistent IR."	9.24	Add on DPP-4 inhibitor alogliptin alone or in combination with pioglitazone improved β-cell function and insulin sensitivity in metformin treated PCOS. ( Goricar, K; Janez, A; Jensterle, M, 2017)
" The current study investigated the effects of alogliptin, a DPP-4 inhibitor, on the progression of carotid atherosclerosis in patients with type 2 diabetes mellitus (T2DM)."	9.22	Alogliptin, a Dipeptidyl Peptidase 4 Inhibitor, Prevents the Progression of Carotid Atherosclerosis in Patients With Type 2 Diabetes: The Study of Preventive Effects of Alogliptin on Diabetic Atherosclerosis (SPEAD-A). ( Gosho, M; Jinnouchi, H; Kaneto, H; Katakami, N; Kosugi, K; Kuribayashi, N; Mita, T; Onuma, T; Osonoi, T; Shimomura, I; Shiraiwa, T; Umayahara, Y; Watada, H; Yamamoto, T; Yokoyama, H; Yoshii, H, 2016)
"5% decrease from baseline) with no weight gain and no hypoglycaemic events with alogliptin 12."	9.22	Comparison of alogliptin and glipizide for composite endpoint of glycated haemoglobin reduction, no hypoglycaemia and no weight gain in type 2 diabetes mellitus. ( Chaudhari, P; Del Prato, S; Fleck, P; Wilson, C, 2016)
" The EXAMINE trial confirmed noninferiority of the dipeptidyl dipeptidase 4 inhibitor alogliptin to placebo on major adverse cardiac event rates in a post-acute coronary syndrome (ACS) T2DM population."	9.22	Ischemic cardiac outcomes and hospitalizations according to prior macrovascular disease status in patients with type 2 diabetes and recent acute coronary syndrome from the Examination of Cardiovascular Outcomes with Alogliptin versus Standard of Care tria ( Bakris, GL; Cannon, CP; Cushman, WC; Kupfer, S; Liu, Y; Mehta, CR; Menon, V; Shimada, YJ; White, WB; Wilson, C; Zannad, F, 2016)
"In patients with type 2 diabetes and recent acute coronary syndromes, alogliptin did not increase the risk of heart failure outcomes."	9.20	Heart failure and mortality outcomes in patients with type 2 diabetes taking alogliptin versus placebo in EXAMINE: a multicentre, randomised, double-blind trial. ( Bakris, GL; Cannon, CP; Cushman, WC; Fleck, PR; Kupfer, S; Lam, H; Mehta, CR; Menon, V; Perez, AT; White, WB; Wilson, C; Zannad, F, 2015)
"Adding alogliptin to previous insulin therapy (with or without metformin) significantly improved glycaemic control in patients with type 2 diabetes inadequately controlled on insulin, without causing weight gain or increasing the incidence of hypoglycaemia."	9.14	Alogliptin added to insulin therapy in patients with type 2 diabetes reduces HbA(1C) without causing weight gain or increased hypoglycaemia. ( Fleck, PR; Gross, JL; Mekki, Q; Rendell, MS; Rosenstock, J; Wilson, CA, 2009)
"Approximately 5,400 men and women with type 2 diabetes and ACS (acute myocardial infarction or unstable angina) are being recruited and will be followed up for up to 4."	6.76	EXamination of cArdiovascular outcoMes with alogliptIN versus standard of carE in patients with type 2 diabetes mellitus and acute coronary syndrome (EXAMINE): a cardiovascular safety study of the dipeptidyl peptidase 4 inhibitor alogliptin in patients wi ( Bakris, GL; Bergenstal, RM; Cannon, CP; Cushman, WC; Fleck, P; Heller, S; Mehta, C; Nissen, SE; Perez, A; White, WB; Wilson, C; Zannad, F, 2011)
" All participants had a documented history of coronary heart disease or high cardiovascular risk at screening and received aspirin (acetylsalicylic acid) 100 mg daily throughout the trial."	5.51	Efficacy and safety of alogliptin versus acarbose in Chinese type 2 diabetes patients with high cardiovascular risk or coronary heart disease treated with aspirin and inadequately controlled with metformin monotherapy or drug-naive: A multicentre, randomi ( Gao, B; Gao, W; Ji, Q; Wan, H; Xu, F; Zhang, X; Zhou, R, 2022)
"Once-weekly trelagliptin and once-daily alogliptin improved glycemic control and reduced GV without inducing hypoglycemia."	5.30	A Randomized Pilot Study of the Effect of Trelagliptin and Alogliptin on Glycemic Variability in Patients with Type 2 Diabetes. ( Koike, Y; Miyata, K; Nishimura, R; Osonoi, T; Shimasaki, Y, 2019)
"Patients with type 2 diabetes and recent acute coronary syndrome were randomized to alogliptin or placebo and standard of care."	5.27	Alogliptin in Patients with Type 2 Diabetes Receiving Metformin and Sulfonylurea Therapies in the EXAMINE Trial. ( Bergenstal, RM; Cannon, CP; Heller, SR; Howitt, H; Khunti, K; White, WB, 2018)
" The aim of the study was to evaluate whether dipeptidyl peptidase-4 (DPP-4) inhibitor alogliptin (ALO) alone or in combination with pioglitazone (PIO) improves β-cell function along with insulin resistance (IR) in metformin (MET) treated obese women with PCOS with persistent IR."	5.24	Add on DPP-4 inhibitor alogliptin alone or in combination with pioglitazone improved β-cell function and insulin sensitivity in metformin treated PCOS. ( Goricar, K; Janez, A; Jensterle, M, 2017)
"The EXAMINE trial randomized 5380 patients with type 2 diabetes (T2DM) and a recent acute coronary syndrome (ACS) event, in 49 countries, to double-blind treatment with alogliptin or placebo in addition to standard of care."	5.24	Relationship of glycated haemoglobin and reported hypoglycaemia to cardiovascular outcomes in patients with type 2 diabetes and recent acute coronary syndrome events: The EXAMINE trial. ( Bakris, GL; Bergenstal, RM; Cannon, CP; Cushman, WC; Gourlie, NM; Heller, SR; Kupfer, S; Liu, Y; Mehta, CR; Nissen, SE; White, WB; Wilson, CA; Zannad, F, 2017)
" The current study investigated the effects of alogliptin, a DPP-4 inhibitor, on the progression of carotid atherosclerosis in patients with type 2 diabetes mellitus (T2DM)."	5.22	Alogliptin, a Dipeptidyl Peptidase 4 Inhibitor, Prevents the Progression of Carotid Atherosclerosis in Patients With Type 2 Diabetes: The Study of Preventive Effects of Alogliptin on Diabetic Atherosclerosis (SPEAD-A). ( Gosho, M; Jinnouchi, H; Kaneto, H; Katakami, N; Kosugi, K; Kuribayashi, N; Mita, T; Onuma, T; Osonoi, T; Shimomura, I; Shiraiwa, T; Umayahara, Y; Watada, H; Yamamoto, T; Yokoyama, H; Yoshii, H, 2016)
"5% decrease from baseline) with no weight gain and no hypoglycaemic events with alogliptin 12."	5.22	Comparison of alogliptin and glipizide for composite endpoint of glycated haemoglobin reduction, no hypoglycaemia and no weight gain in type 2 diabetes mellitus. ( Chaudhari, P; Del Prato, S; Fleck, P; Wilson, C, 2016)
" The EXAMINE trial confirmed noninferiority of the dipeptidyl dipeptidase 4 inhibitor alogliptin to placebo on major adverse cardiac event rates in a post-acute coronary syndrome (ACS) T2DM population."	5.22	Ischemic cardiac outcomes and hospitalizations according to prior macrovascular disease status in patients with type 2 diabetes and recent acute coronary syndrome from the Examination of Cardiovascular Outcomes with Alogliptin versus Standard of Care tria ( Bakris, GL; Cannon, CP; Cushman, WC; Kupfer, S; Liu, Y; Mehta, CR; Menon, V; Shimada, YJ; White, WB; Wilson, C; Zannad, F, 2016)
"In patients with type 2 diabetes and recent acute coronary syndromes, alogliptin did not increase the risk of heart failure outcomes."	5.20	Heart failure and mortality outcomes in patients with type 2 diabetes taking alogliptin versus placebo in EXAMINE: a multicentre, randomised, double-blind trial. ( Bakris, GL; Cannon, CP; Cushman, WC; Fleck, PR; Kupfer, S; Lam, H; Mehta, CR; Menon, V; Perez, AT; White, WB; Wilson, C; Zannad, F, 2015)
"Alogliptin monotherapy maintained glycaemic control comparable to that of glipizide in elderly patients with T2DM over 1 year of treatment, with substantially lower risk of hypoglycaemia and without weight gain."	5.17	Alogliptin versus glipizide monotherapy in elderly type 2 diabetes mellitus patients with mild hyperglycaemia: a prospective, double-blind, randomized, 1-year study. ( Fleck, P; Rosenstock, J; Wilson, C, 2013)
"We randomly assigned patients with type 2 diabetes and either an acute myocardial infarction or unstable angina requiring hospitalization within the previous 15 to 90 days to receive alogliptin or placebo in addition to existing antihyperglycemic and cardiovascular drug therapy."	5.17	Alogliptin after acute coronary syndrome in patients with type 2 diabetes. ( Bakris, GL; Bergenstal, RM; Cannon, CP; Cushman, WC; Fleck, PR; Heller, SR; Kupfer, S; Mehta, CR; Nissen, SE; Perez, AT; White, WB; Wilson, C; Zannad, F, 2013)
"Adding alogliptin to previous insulin therapy (with or without metformin) significantly improved glycaemic control in patients with type 2 diabetes inadequately controlled on insulin, without causing weight gain or increasing the incidence of hypoglycaemia."	5.14	Alogliptin added to insulin therapy in patients with type 2 diabetes reduces HbA(1C) without causing weight gain or increased hypoglycaemia. ( Fleck, PR; Gross, JL; Mekki, Q; Rendell, MS; Rosenstock, J; Wilson, CA, 2009)
"Dipeptidyl peptidase-4 (DPP-4) inhibitors such as alogliptin are becoming more widely established as treatment options for patients with type 2 diabetes (T2DM) because of their ability to improve glycemic control without increasing the risk of hypoglycemia or weight gain."	4.93	Alogliptin for the treatment of type 2 diabetes: a drug safety evaluation. ( Seino, Y; Yabe, D, 2016)
"There are data from studies using sitagliptin, saxagliptin, and alogliptin showing that these agents may increase the risk of hospitalization for heart failure."	4.90	Do dipeptidyl peptidase IV (DPP-IV) inhibitors cause heart failure? ( Clifton, P, 2014)
" Direct comparisons with active glucose-lowering comparators in drug-naive patients have demonstrated that DPP-4 inhibitors exert slightly less pronounced HbA(1c) reduction than metformin (with the advantage of better gastrointestinal tolerability) and similar glucose-lowering effects as with a thiazolidinedione (TZD; with the advantage of no weight gain)."	4.88	DPP-4 inhibitors in the management of type 2 diabetes: a critical review of head-to-head trials. ( Scheen, AJ, 2012)
" The moderate hyperglycaemia seen in prediabetes can be treated using a combination of metformin and lifestyle interventions (low-calorie diets and exercising)."	4.12	Ameliorative Effects of a Rhenium (V) Compound with Uracil-Derived Ligand Markers Associated with Hyperglycaemia-Induced Renal Dysfunction in Diet-Induced Prediabetic Rats. ( Akinnuga, AM; Booysen, IN; Ismail, MB; Khathi, A; Khumalo, B; Ngubane, P; Sibiya, NH; Siboto, A, 2022)
"The EXAMINE trial included 5380 patients with T2D and a recent acute coronary syndrome, who were randomized to alogliptin or placebo."	4.02	Body weight changes in patients with type 2 diabetes and a recent acute coronary syndrome: an analysis from the EXAMINE trial. ( Bakris, G; Ferreira, JP; Mehta, C; Rossignol, P; White, WB; Zannad, F, 2021)
" In the cardiovascular subset, there was an SDR for heart failure with linagliptin (EB05 = 2782."	3.88	Cardiovascular safety signals with dipeptidyl peptidase-4 inhibitors: A disproportionality analysis among high-risk patients. ( Alexander, GC; Baksh, SN; McAdams-DeMarco, M; Segal, JB, 2018)
" The objective of this model-based meta-analysis was to describe the time course of HbA1c response after dosing with alogliptin (ALOG), saxagliptin (SAXA), sitagliptin (SITA), or vildagliptin (VILD)."	3.86	Quantitative model of the relationship between dipeptidyl peptidase-4 (DPP-4) inhibition and response: meta-analysis of alogliptin, saxagliptin, sitagliptin, and vildagliptin efficacy results. ( Barbee, T; Correa, I; Fredrickson, J; Gibbs, JP; Gibbs, MA; Lin, SL; Smith, B, 2012)
" Patients with type 2 diabetes who have intermediate coronary artery stenosis (diameter stenosis <70%) as evaluated by CCTA will be treated with 25mg/day of alogliptin."	3.85	Effects of alogliptin on fractional flow reserve evaluated by coronary computed tomography angiography in patients with type 2 diabetes: Rationale and design of the TRACT study. ( Fukui, K; Hibi, K; Kishi, S; Michishita, I; Nozue, T; Sozu, T; Takamura, T, 2017)
"We report a case in which angioedema induced by vildagliptin disappeared after changing to another DPP-4 inhibitor, alogliptin."	3.79	Dipeptidyl peptidase-4 inhibitors and angioedema: a class effect? ( Itoh, H; Saisho, Y, 2013)
" In the double-blind phase, the incidence of treatment-emergent adverse events (TEAEs) was 72."	2.94	Efficacy and safety of trelagliptin in Japanese patients with type 2 diabetes with severe renal impairment or end-stage renal disease: Results from a randomized, phase 3 study. ( Achira, M; Ishida, K; Kaku, K; Shimizu, K; Umeda, Y, 2020)
"Eighty patients with type 2 diabetes and HbA1c between 7."	2.90	Alogliptin and Gliclazide Similarly Increase Circulating Endothelial Progenitor Cells in Type 2 Diabetes Patients. ( Greco, EL; Greco, G; Negro, R, 2019)
" Adverse events were reported in 42."	2.87	Efficacy and safety of once-weekly oral trelagliptin switched from once-daily dipeptidyl peptidase-4 inhibitor in patients with type 2 diabetes mellitus: An open-label, phase 3 exploratory study. ( Inagaki, N; Kaku, K; Kuroda, S; Sano, H; Seki, Y, 2018)
"The study participants were 87 type 2 diabetes mellitus patients who had been treated with dipeptidyl peptidase-4 inhibitors for ≥8 weeks and had a low-density lipoprotein cholesterol (LDL-C) level of ≥120 mg/dL."	2.87	Comparison of effects of anagliptin and alogliptin on serum lipid profile in type 2 diabetes mellitus patients. ( Arao, T; Kobayashi, T; Kurozumi, A; Masuda, D; Okada, Y; Tanaka, Y; Yamashita, S, 2018)
"Alogliptin did not increase the risk of either first or recurrent CV events when compared with placebo in patients with T2DM and recent acute coronary syndrome."	2.87	Total cardiovascular events analysis of the EXAMINE trial in patients with type 2 diabetes and recent acute coronary syndrome. ( Bergenstal, RM; Cannon, CP; Cavender, MA; Cushman, WC; Heller, S; Liu, Y; Massaro, JM; Mehta, CR; White, WB; Zannad, F, 2018)
"Early after an ACS, patients with type 2 diabetes mellitus experience a significant burden of HF events and recurrent ACS."	2.87	Early and Chronic Dipeptidyl-Peptidase-IV Inhibition and Cardiovascular Events in Patients With Type 2 Diabetes Mellitus After an Acute Coronary Syndrome: A Landmark Analysis of the EXAMINE Trial. ( Bakris, GL; Cannon, CP; Cushman, WC; Liu, Y; Sharma, A; White, WB; Zannad, F, 2018)
" Primary endpoints were HbA1c change from baseline to the end of the DB phase and adverse events (AEs)."	2.87	Efficacy and safety of trelagliptin in combination with insulin therapy in Japanese patients with type 2 diabetes: Results from a randomized, Phase IV study. ( Ishida, K; Kaku, K; Kuroda, S; Umeda, Y, 2018)
"Conclusions In patients with type 2 diabetes mellitus and recent acute coronary syndrome, average BP s <130/80 mm Hg were associated with worsened cardiovascular outcomes."	2.87	Average Clinician-Measured Blood Pressures and Cardiovascular Outcomes in Patients With Type 2 Diabetes Mellitus and Ischemic Heart Disease in the EXAMINE Trial. ( Bakris, GL; Bergenstal, R; Cannon, CP; Cushman, WC; Heller, SR; Jalil, F; Liu, Y; Mehta, C; White, WB; Zannad, F, 2018)
" A similar percentage of patients experienced drug-related, treatment-emergent adverse events in the alogliptin and placebo arms."	2.84	Efficacy and safety of alogliptin in patients with type 2 diabetes mellitus: A multicentre randomized double-blind placebo-controlled Phase 3 study in mainland China, Taiwan, and Hong Kong. ( Chan, J; Han, P; Hsieh, AT; Ji, Q; Li, C; Li, W; Lu, J; Pan, C; Yang, J; Zeng, J, 2017)
"In Study 1, DPP-4 inhibitor-naive type 2 diabetes (T2DM) were randomly assigned to alogliptin 25 mg/day or vildagliptin 50 mg twice daily."	2.84	Comparative analysis of the effects of alogliptin and vildagliptin on glucose metabolism in type 2 diabetes mellitus. ( Arao, T; Hajime, M; Kuno, F; Kurozumi, A; Mine, S; Miyazaki, M; Mori, H; Narisawa, M; Okada, Y; Sonoda, S; Sugai, K; Tanaka, K; Tanaka, Y; Torimoto, K, 2017)
" The overall frequency of adverse events was similar among the groups."	2.84	Randomized, double-blind, phase III study to evaluate the efficacy and safety of once-daily treatment with alogliptin and metformin hydrochloride in Japanese patients with type 2 diabetes. ( Kaku, K; Katou, M; Kinugawa, Y; Nishiyama, Y; Sumino, S, 2017)
"Patients with type 2 diabetes mellitus, glycohemoglobin between 6."	2.84	Serial Measurement of High-Sensitivity Troponin I and Cardiovascular Outcomes in Patients With Type 2 Diabetes Mellitus in the EXAMINE Trial (Examination of Cardiovascular Outcomes With Alogliptin Versus Standard of Care). ( Bakris, GL; Cannon, CP; Cavender, MA; Cushman, WC; Gao, Q; Jarolim, P; Kupfer, S; Mehta, CR; Morrow, DA; White, WB; Zannad, F, 2017)
"A total of 50 outpatients with type 2 diabetes mellitus (T2DM) treated with Alo and 47 outpatients with T2DM treated with Pio were switched to Alo-Pio FDCT, and its efficacy and usefulness were evaluated."	2.84	Fixed-dose combination of alogliptin/pioglitazone improves glycemic control in Japanese patients with type 2 diabetes mellitus independent of body mass index. ( Aoki, C; Aso, Y; Kasai, K; Kuroda, H; Sagara, M; Shimizu, M; Suzuki, K, 2017)
"Trelagliptin is a novel once-weekly oral dipeptidyl peptidase-4 inhibitor for type 2 diabetes mellitus that was first approved in Japan."	2.82	Long-term safety and efficacy of a novel once-weekly oral trelagliptin as monotherapy or in combination with an existing oral antidiabetic drug in patients with type 2 diabetes mellitus: A 52-week open-label, phase 3 study. ( Inagaki, N; Kaku, K; Kuroda, S; Sano, H; Seki, Y, 2016)
"In patients with type 2 diabetes and a recent ACS, the risk of CV death was higher after a postrandomization, nonfatal CV event, particularly heart failure, compared with those who did not experience a CV event."	2.82	Cardiovascular Mortality in Patients With Type 2 Diabetes and Recent Acute Coronary Syndromes From the EXAMINE Trial. ( Bakris, GL; Bergenstal, RM; Cannon, CP; Cushman, WC; Fleck, PR; Heller, SR; Kupfer, S; Lei, L; Mehta, CR; Nissen, SE; White, WB; Wilson, CA; Zannad, F, 2016)
"Patients with type 2 diabetes mellitus and a recent acute coronary syndrome were randomly assigned to receive the dipeptidyl peptidase 4 inhibitor alogliptin or placebo added to existing antihyperglycemic and cardiovascular prophylactic therapies."	2.82	Angiotensin-Converting Enzyme Inhibitor Use and Major Cardiovascular Outcomes in Type 2 Diabetes Mellitus Treated With the Dipeptidyl Peptidase 4 Inhibitor Alogliptin. ( Bakris, GL; Bergenstal, RM; Cannon, CP; Cushman, WC; Heller, SK; Kupfer, S; Mehta, CR; Nissen, SE; White, WB; Wilson, CA; Zannad, F, 2016)
"Trelagliptin treatment showed no significant changes in FMD (2."	2.82	Effect of trelagliptin on vascular endothelial functions and serum adiponectin level in patients with type 2 diabetes: a preliminary single-arm prospective pilot study. ( Betou, K; Fujiwara, R; Ida, S; Imataka, K; Ishihara, Y; Kaneko, R; Kobayashi, C; Monguchi, K; Murata, K; Takahashi, H; Uchida, A, 2016)
"Treatment naïve subjects with type 2 diabetes received 12."	2.80	Alogliptin: a new dipeptidyl peptidase-4 inhibitor with potential anti-atherogenic properties. ( Hirate, M; Kaneoka, N; Kutoh, E, 2015)
"Trelagliptin is a novel once-weekly oral DPP-4 inhibitor."	2.80	Once-weekly trelagliptin versus daily alogliptin in Japanese patients with type 2 diabetes: a randomised, double-blind, phase 3, non-inferiority study. ( Inagaki, N; Kaku, K; Kuroda, S; Maezawa, H; Onouchi, H, 2015)
" The overall incidence rates of treatment-emergent adverse events were similar among the treatment groups."	2.80	Efficacy and safety of pioglitazone added to alogliptin in Japanese patients with type 2 diabetes mellitus: a multicentre, randomized, double-blind, parallel-group, comparative study. ( Igeta, M; Kaku, K; Katou, M; Ohira, T; Sano, H, 2015)
" The percentage of subjects who experienced all adverse events including hypoglycemia with alogliptin were comparable to those with placebo."	2.80	[Efficacy and safety of alogliptin in treatment of type 2 diabetes mellitus: a multicenter, randomized, double-blind, placebo-controlled phase III clinical trial in mainland China]. ( Bu, R; Gu, W; Han, P; Ji, Q; Jiang, Z; Lei, M; Li, C; Li, L; Li, W; Li, X; Li, Z; Liu, J; Liu, X; Liu, Y; Liu, Z; Lu, J; Lyu, X; Pan, C; Peng, Y; Qu, S; Shi, B; Song, Q; Xu, X; Xue, Y; Yan, L; Yang, J; Zeng, J; Zheng, B, 2015)
"In patients with type 2 diabetes, improving adherence to medication is important in order to maintain favourable glycaemic control during long-term treatment and, thus, prevent the onset or aggravation of complications."	2.79	SYR-472, a novel once-weekly dipeptidyl peptidase-4 (DPP-4) inhibitor, in type 2 diabetes mellitus: a phase 2, randomised, double-blind, placebo-controlled trial. ( Funao, N; Inagaki, N; Kaku, K; Kuroda, S; Onouchi, H; Sano, H, 2014)
" Incidences of adverse effects were comparable between groups, with no relevant increases in hypoglycemia or weight gain seen."	2.79	Efficacy and safety of alogliptin added to insulin in Japanese patients with type 2 diabetes: a randomized, double-blind, 12-week, placebo-controlled trial followed by an open-label, long-term extension phase. ( Kaku, K; Kanoo, T; Katou, M; Mori, M; Seino, Y, 2014)
"We evaluated the incidence of CV events in patients treated with alogliptin, placebo or comparator antihyperglycaemic drugs in the clinical trial database for alogliptin using the composite major adverse cardiovascular event (MACE) endpoints of CV death, non-fatal myocardial infarction and non-fatal stroke."	2.78	Cardiovascular safety of the dipetidyl peptidase-4 inhibitor alogliptin in type 2 diabetes mellitus. ( Fleck, P; Hisada, M; Menon, V; Munsaka, M; Pratley, R; White, WB; Wilson, C, 2013)
"Alogliptin treatment significantly reduced fasting glucose (160."	2.78	Efficacy of alogliptin, a dipeptidyl peptidase-4 inhibitor, on glucose parameters, the activity of the advanced glycation end product (AGE) - receptor for AGE (RAGE) axis and albuminuria in Japanese type 2 diabetes. ( Eto, T; Hayakawa, M; Hirayama, N; Kario, K; Kitamura, K; Koga, M; Kuroki, K; Matsuo, T; Mishima, O; Nagata, N; Nishino, Y; Sagara, S; Sakata, K; Takeuchi, M; Tamaki, N; Watanabe, R; Yamagishi, S; Yano, Y; Yokota, N, 2013)
" The safety endpoints consisted of the incidence of hypoglycemia and other adverse events."	2.78	[The design and baseline characteristics of a phase III study to evaluate the efficacy and safety of alogliptin versus placebo in type 2 diabetes mellitus in Mainland China]. ( Bu, RF; Gu, W; Han, P; Ji, QH; Jiang, ZS; Lei, MX; Li, CJ; Li, L; Li, WH; Li, XF; Li, XJ; Li, ZF; Liu, JD; Liu, XM; Liu, Y; Liu, ZM; Lu, JM; Lü, XF; Pan, CY; Peng, YD; Qu, S; Shi, BY; Song, QH; Xu, XJ; Xue, YM; Yan, L; Yang, JK; Zeng, JE; Zheng, BZ, 2013)
"Alogliptin treatment significantly suppressed the postprandial elevation in serum triglyceride (incremental area under the curve [AUC]; 279 ± 31 vs."	2.78	Alogliptin ameliorates postprandial lipemia and postprandial endothelial dysfunction in non-diabetic subjects: a preliminary report. ( Ito, H; Kohno, K; Kusano, K; Miyoshi, T; Morita, H; Nakamura, K; Noda, Y; Oe, H; Ohno, Y; Toh, N, 2013)
"The aim of the study was to assess the efficacy and tolerability of alogliptin combined with pioglitazone in metformin-treated type 2 diabetic patients."	2.77	Efficacy and tolerability of the DPP-4 inhibitor alogliptin combined with pioglitazone, in metformin-treated patients with type 2 diabetes. ( Burant, CF; DeFronzo, RA; Fleck, P; Mekki, Q; Pratley, RE; Wilson, C, 2012)
" The primary endpoint during the long-term extension phase was adverse events."	2.77	Efficacy and safety of alogliptin added to metformin in Japanese patients with type 2 diabetes: a randomized, double-blind, placebo-controlled trial with an open-label, long-term extension study. ( Hirayama, M; Hiroi, S; Kaku, K; Miyata, Y; Seino, Y, 2012)
" Patients had an option to continue in a 40-week, open-label extension study, with those originally randomized to alogliptin remaining on the same dosage regimen while patients treated with placebo were randomly allocated to alogliptin 12."	2.76	Efficacy and safety of alogliptin added to pioglitazone in Japanese patients with type 2 diabetes: a randomized, double-blind, placebo-controlled trial with an open-label long-term extension study. ( Hirayama, M; Hiroi, S; Itayasu, T; Kaku, K; Seino, Y, 2011)
" Safety endpoints were the occurrence of adverse events, vital sign measurements, physical examination and ECG findings, and laboratory test results recorded over the entire 52-week period."	2.76	Efficacy and safety of alogliptin in Japanese patients with type 2 diabetes mellitus: a randomized, double-blind, dose-ranging comparison with placebo, followed by a long-term extension study. ( Fujita, T; Hirayama, M; Hiroi, S; Kaku, K; Seino, Y, 2011)
"Approximately 5,400 men and women with type 2 diabetes and ACS (acute myocardial infarction or unstable angina) are being recruited and will be followed up for up to 4."	2.76	EXamination of cArdiovascular outcoMes with alogliptIN versus standard of carE in patients with type 2 diabetes mellitus and acute coronary syndrome (EXAMINE): a cardiovascular safety study of the dipeptidyl peptidase 4 inhibitor alogliptin in patients wi ( Bakris, GL; Bergenstal, RM; Cannon, CP; Cushman, WC; Fleck, P; Heller, S; Mehta, C; Nissen, SE; Perez, A; White, WB; Wilson, C; Zannad, F, 2011)
"In patients with type 2 diabetes inadequately controlled by glyburide monotherapy, the addition of alogliptin resulted in clinically significant reductions in HbA1c without increased incidence of hypoglycaemia."	2.74	Efficacy and safety of the dipeptidyl peptidase-4 inhibitor alogliptin in patients with type 2 diabetes inadequately controlled by glyburide monotherapy. ( Fleck, PR; Kipnes, MS; Mekki, Q; Pratley, RE; Wilson, C, 2009)
"Alogliptin is an effective and safe treatment for type 2 diabetes when added to metformin for patients not sufficiently controlled on metformin monotherapy."	2.74	Efficacy and safety of adding the dipeptidyl peptidase-4 inhibitor alogliptin to metformin therapy in patients with type 2 diabetes inadequately controlled with metformin monotherapy: a multicentre, randomised, double-blind, placebo-controlled study. ( Ellis, GC; Fleck, PR; Mekki, Q; Nauck, MA; Wilson, CA, 2009)
" The incidences of overall adverse events and hypoglycemia were similar across treatment groups, but cardiac events occurred more often with active treatment than placebo."	2.74	Efficacy and safety of the dipeptidyl peptidase-4 inhibitor alogliptin added to pioglitazone in patients with type 2 diabetes: a randomized, double-blind, placebo-controlled study. ( Fleck, PR; Mekki, Q; Pratley, RE; Reusch, JE; Wilson, CA, 2009)
" Overall, incidences of adverse events (67."	2.73	Efficacy and safety of the dipeptidyl peptidase-4 inhibitor alogliptin in patients with type 2 diabetes and inadequate glycemic control: a randomized, double-blind, placebo-controlled study. ( DeFronzo, RA; Fleck, PR; Mekki, Q; Wilson, CA, 2008)
"Alogliptin is a highly selective dipeptidyl peptidase-4 (DPP-4) inhibitor that is under development for the treatment of type 2 diabetes (T2D)."	2.73	Pharmacokinetic, pharmacodynamic, and tolerability profiles of the dipeptidyl peptidase-4 inhibitor alogliptin: a randomized, double-blind, placebo-controlled, multiple-dose study in adult patients with type 2 diabetes. ( Christopher, R; Covington, P; Davenport, M; Fleck, P; Karim, A; Mekki, QA; Wann, ER, 2008)
"All trials performed on type 2 diabetes, with duration ≥ 24 weeks, and comparing of DPP4i with placebo or active drugs were collected."	2.66	Risk of cancer in patients treated with dipeptidyl peptidase-4 inhibitors: an extensive meta-analysis of randomized controlled trials. ( Dicembrini, I; Mannucci, E; Monami, M; Montereggi, C; Nreu, B, 2020)
"Trelagliptin is a novel, long-acting dipeptidyl peptidase-4 (DPP-4) inhibitor approved for the treatment of type 2 diabetes mellitus (T2DM) in japan."	2.55	Safety evaluation of trelagliptin in the treatment of Japanese type 2 diabetes mellitus patients. ( Kaku, K, 2017)
"The incidence of acute pancreatitis was significantly increased in the gliptin-treated patients when compared with the control groups (odds ratio 1."	2.55	Combined Analysis of Three Large Interventional Trials With Gliptins Indicates Increased Incidence of Acute Pancreatitis in Patients With Type 2 Diabetes. ( Raz, I; Tkáč, I, 2017)
" Alogliptin appears to be weight neutral and is relatively well tolerated with few adverse effects."	2.52	Alogliptin: safety, efficacy, and clinical implications. ( Cole, SW; Marino, AB, 2015)
"Alogliptin benzoate is a newly developed, highly selective DPP-4 inhibitor which has been approved in many countries throughout the world."	2.52	Alogliptin benzoate for management of type 2 diabetes. ( Saisho, Y, 2015)
" No clinically relevant pharmacokinetic interactions between the two agents have been described and the fixed-dose combination has shown bioequivalence with alogliptin and pioglitazone given separately."	2.52	Pharmacokinetics and clinical evaluation of the alogliptin plus pioglitazone combination for type 2 diabetes. ( Scheen, AJ, 2015)
"Trelagliptin (Zafatek(®)) is an orally active dipeptidyl peptidase (DPP)-4 inhibitor developed by Takeda and approved in Japan for the treatment of type 2 diabetes mellitus (T2DM)."	2.52	Trelagliptin: First Global Approval. ( McKeage, K, 2015)
" Due to the convenient dosing regimen, it is expected to be widely used in the clinical setting."	2.52	First novel once-weekly DPP-4 inhibitor, trelagliptin, for the treatment of type 2 diabetes mellitus. ( Kaku, K, 2015)
"Alogliptin is a selective, orally bioavailable inhibitor of the enzymatic activity of dipeptidyl peptidase-4 (DPP-4)."	2.50	Alogliptin: A new dipeptidyl peptidase-4 inhibitor for the management of type 2 diabetes mellitus. ( Erowele, G; Ndefo, UA; Okoli, O, 2014)
"Effective, evidence-based management of type 2 diabetes (T2D) requires the integration of the best available evidence with clinical experience and patient preferences."	2.50	Incorporating incretin-based therapies into clinical practice for patients with type 2 diabetes. ( Tibaldi, JM, 2014)
"Alogliptin is a DPP-4 inhibitor that can help in improving glycemic control in patients with type 2 diabetes, including the elderly."	2.50	Alogliptin benzoate for the treatment of type 2 diabetes. ( Seino, Y; Yabe, D, 2014)
" Four of the five commercially available DPP-4 inhibitors are subject to significant renal clearance, and pharmacokinetic studies in people with renal impairment have led to lower recommended doses based on creatinine clearance in order to prevent drug accumulation."	2.50	Dipeptidyl peptidase-4 inhibitors: pharmacokinetics, efficacy, tolerability and safety in renal impairment. ( Davis, TM, 2014)
"This review considers the pharmacokinetic profile, adverse effects and drug interactions of DPP-4 inhibitors."	2.50	The pharmacokinetic considerations and adverse effects of DPP-4 inhibitors [corrected]. ( Athyros, VG; Elisaf, MS; Filippatos, TD, 2014)
" The main differences between the five gliptins on the market include: potency, target selectivity, oral bioavailability, long or short half-life, high or low binding to plasma proteins, metabolism, presence of active or inactive metabolites, excretion routes, dosage adjustment for renal and liver insufficiency, and potential drug-drug interactions."	2.49	Dipeptidyl peptidase-4 inhibitors in type 2 diabetes therapy--focus on alogliptin. ( Capuano, A; Esposito, K; Giugliano, D; Maiorino, MI; Rossi, F; Sportiello, L, 2013)
"Alogliptin is a highly selective and potent competitive inhibitor of DPP-4."	2.49	Alogliptin: a new dipeptidyl peptidase-4 inhibitor for type 2 diabetes mellitus. ( Cabrera, A; Charron, D; Jarvis, CI, 2013)
"Alogliptin is a highly selective inhibitor of the enzyme dipeptidyl peptidase-4 (DPP-4)."	2.48	Alogliptin benzoate for the treatment of type 2 diabetes. ( Andukuri, R; Drincic, A; Rendell, M, 2012)
"The pharmacologic management of type 2 diabetes has changed dramatically in the past two decades."	2.47	Alogliptin for the treatment of type 2 diabetes. ( White, JR, 2011)
"A recent treatment advance for type 2 diabetes is the oral therapy with DPP IV inhibitors."	2.47	Small molecule dipeptidylpeptidase IV inhibitors under investigation for diabetes mellitus therapy. ( Gallwitz, B, 2011)
"Type 2 diabetes is characterized by insulin resistance and pancreatic beta cell dysfunction, and the latter is known to usually progress during the entire disease history."	2.47	[A compounding agent of alogliptin and pioglitazone]. ( Ueki, K, 2011)
"Treatment of patients with type 2 diabetes mellitus (T2DM) traditionally has involved a progression of phases, from conventional lifestyle interventions and monotherapy, to combination therapy involving oral agents, to insulin initiation and its use either alone or with oral pharmacotherapy."	2.46	The physiologic role of incretin hormones: clinical applications. ( Cefalu, WT, 2010)
"Successful management of type 2 diabetes mellitus (T2DM) requires attention to additional conditions often associated with hyperglycemia including overweight or obesity, dyslipidemia and hypertension, as each has some relationship with microvascular or macrovascular complications."	2.46	Managing type 2 diabetes in the primary care setting: beyond glucocentricity. ( Kuritzky, L, 2010)
"Patients with type 2 diabetes mellitus (T2DM) are generally treated with many pharmacological compounds and are exposed to a high risk of drug-drug interactions."	2.46	Dipeptidylpeptidase-4 inhibitors (gliptins): focus on drug-drug interactions. ( Scheen, AJ, 2010)
"Pioglitazone is a potent insulin sensitizer, improves pancreatic beta cell function and has been shown in several outcome trials to lower the risk of atherosclerotic and cardiovascular events."	2.46	Pioglitazone and alogliptin combination therapy in type 2 diabetes: a pathophysiologically sound treatment. ( Cersosimo, E; DeFronzo, RA; Triplitt, C, 2010)
"Alogliptin is a potent, highly selective dipeptidyl peptidase-4 inhibitor now undergoing clinical testing to support a new drug application for the treatment of type 2 diabetes."	2.46	Alogliptin: a novel molecule for improving glycemic control in type II diabetes mellitus. ( Deshpande, SS; Ghatak, SB; Panchal, SJ; Patel, DS; Shanker, N; Srivstava, A, 2010)
"Alogliptin (Nesina®) is a dipeptidyl peptidase-4 inhibitor that is approved in Japan for the treatment of adult patients with type 2 diabetes mellitus that is inadequately controlled by diet and exercise alone or by diet plus treatment with an α-glucosidase inhibitor."	2.46	Alogliptin: a review of its use in the management of type 2 diabetes mellitus. ( Scott, LJ, 2010)
"Alogliptin is a potent, highly selective dipeptidyl peptidase-4 inhibitor now undergoing clinical testing to support a new drug application for the treatment of type 2 diabetes."	2.45	Alogliptin: a new, highly selective dipeptidyl peptidase-4 inhibitor for the treatment of type 2 diabetes. ( Pratley, RE, 2009)
"Early diagnosis of diabetic kidney disease (DKD) has long been a complex problem."	1.72	Extracellular vesicles metabolic changes reveals plasma signature in stage-dependent diabetic kidney disease. ( Chen, L; Chen, T; Hu, L; Jin, J; Pan, Y; Ruan, L; Yang, H, 2022)
" Symptomatic hypoglycemia, pancreatitis, skin disorders of non-extrinsic origin, severe infections, and cancer were collected as major adverse events (AEs)."	1.62	Long-term safety and efficacy of alogliptin, a DPP-4 inhibitor, in patients with type 2 diabetes: a 3-year prospective, controlled, observational study (J-BRAND Registry). ( Abiko, A; Araki, E; Fujimoto, S; Fujiwara, M; Hayashi, M; Inagaki, N; Kadowaki, T; Katagiri, H; Miyoshi, H; Nakamura, J; Naruse, K; Nishimura, R; Okada, Y; Shikata, K; Shimada, A; Shimomura, I; Tanizawa, Y; Ueki, K; Watada, H; Yamada, Y; Yamazaki, T, 2021)
"Alogliptin (ALG), an inhibitor of dipeptidylpeptidase-4, is used in the management of type 2 diabetes mellitus, and has a high absorption rate (>60-71%), despite its low lipophilicity (logP=-1."	1.62	Intestinal Absorption of Alogliptin Is Mediated by a Fruit-Juice-Sensitive Transporter. ( Abe, M; Ishii, M; Kikuchi, T; Morimoto, K; Ogihara, T; Oikawa, E; Sasaki, M; Tomita, M, 2021)
"Standard methods for meta-analysis of dose-response data in epidemiology assume a model with a single scalar parameter, such as log-linear relationships between exposure and outcome; such models are implicitly unbounded."	1.48	Methods for meta-analysis of pharmacodynamic dose-response data with application to multi-arm studies of alogliptin. ( Aronson, JK; Langford, O; Stevens, RJ; van Valkenhoef, G, 2018)
"Trelagliptin (SYR-472), a novel dipeptidyl peptidase-4 inhibitor, shows sustained efficacy by once-weekly dosing in type 2 diabetes patients."	1.43	Trelagliptin (SYR-472, Zafatek), Novel Once-Weekly Treatment for Type 2 Diabetes, Inhibits Dipeptidyl Peptidase-4 (DPP-4) via a Non-Covalent Mechanism. ( Grimshaw, CE; Jennings, A; Kamran, R; Kinugawa, Y; Kosaka, T; Koumura, E; Nishigaki, N; Sano, H; Shi, L; Takeuchi, K; Tani, A; Ueno, H, 2016)
" This prescribing could have been due to the complexity of different dosing requirements, or a lack of awareness of the need for dose adjustment of most DPP-4 inhibitors in patients with renal impairment."	1.43	Demographic and Clinical Characteristics of Patients With Type 2 Diabetes Mellitus Initiating Dipeptidyl Peptidase 4 Inhibitors: A Retrospective Study of UK General Practice. ( Bingham-Gardiner, P; Bolodeoku, J; Hassan, SW; Lee, S; Scowcroft, A; Spencer, W; Tebboth, A, 2016)
"In patients with type 2 diabetes mellitus (T2DM) inadequately controlled by metformin monotherapy, the addition of alogliptin contributed to clinically significant increases in pulmonary function through regulating glycemia and improving the imbalance of the oxidative-related substances in the serum, without increasing the incidence of hypoglycemia, dyslipidemia, dysarteriotony, and any notable increase in body weight."	1.43	The effect of alogliptin on pulmonary function in obese patients with type 2 diabetes inadequately controlled by metformin monotherapy. ( Dong, QY; Kuang, JS; Li, LB; Liu, XG; Tai, H; Wang, MY; Zhao, YP, 2016)
"Many patients with type 2 diabetes mellitus(T2DM) do not achieve satisfactory glycemic control by monotherapy alone, and often require multiple oral hypoglycemic agents (OHAs)."	1.42	[Fixed-dose combination]. ( Nagai, Y, 2015)
"Treatment naïve subjects with type 2 diabetes mellitus were assigned to either sitagliptin 25-50 mg/day (n = 69) or alogliptin 12."	1.42	Distinct glucose-lowering properties in good responders treated with sitagliptin and alogliptin. ( Hirate, M; Kutoh, E; Wada, A, 2015)
"Alogliptin treatment tended to decrease UAlbCR (99."	1.42	Urinary Angiotensinogen Could Be a Prognostic Marker of Renoprotective Effects of Alogliptin in Patients with Type 2 Diabetes. ( Hayakawa, M; Kobori, H; Mizushige, T; Nishijima, Y; Nishiyama, A; Sakata, K; Yano, Y, 2015)
"We recruited 36 CKD patients with type 2 diabetes."	1.40	Effects of alogliptin in chronic kidney disease patients with type 2 diabetes. ( Mugishima, K; Murasawa, T; Ohno, D; Otsuka, T; Otsuka, Y; Sakai, Y; Sumi, Y; Suzuki, A; Tsuruoka, S, 2014)
"Pioglitazone treatment also resulted in increased expression of markers of mitochondrial biogenesis in brown adipose tissue and white adipose tissue, with mild elevations observed in animals treated with alogliptin alone."	1.40	Administration of pioglitazone alone or with alogliptin delays diabetes onset in UCD-T2DM rats. ( Bettaieb, A; Cummings, BP; Graham, JL; Haj, FG; Havel, PJ; Stanhope, K, 2014)
"20,000 patients with type 2 diabetes will be registered into two groups of 10,000 each: group A patients will be treated with alogliptin, while group B patients will be treated with non-DPP-4 inhibitor OHA(s)."	1.40	Protocol for a large-scale prospective observational study with alogliptin in patients with type 2 diabetes: J-BRAND Registry. ( Inagaki, N; Kadowaki, T; Nakamura, J; Nishimura, R; Shimomura, I; Tanizawa, Y; Ueki, K; Watada, H; Yamada, Y; Yamazaki, T, 2014)
"Patients aged 18 to 80 with type 2 diabetes mellitus and inadequate glycemic control."	1.35	Alogliptin use in elderly people: a pooled analysis from phase 2 and 3 studies. ( Fleck, PR; McCall, T; Mekki, Q; Pratley, RE; Wilson, CA, 2009)

Research

Studies (203)

Authors

Clinical Trials (21)

Trial Overview

Trial Outcomes

Number of Participants Reporting One or More Treatment-emergent Adverse Events

Change From Baseline in AUC for Blood Glucose

Timeframe	Studies, this research(%)	All Research%
pre-1990	0 (0.00)	18.7374
1990's	1 (0.49)	18.2507
2000's	14 (6.90)	29.6817
2010's	166 (81.77)	24.3611
2020's	22 (10.84)	2.80

Authors	Studies
Lin, WQ	1
Cai, ZJ	1
Chen, T	2
Liu, MB	1
Li, N	1
Zheng, B	2
Ferreira, JP	4
Rossignol, P	3
Bakris, G	3
Mehta, C	6
White, WB	21
Zannad, F	19
Tomlinson, B	1
Chan, P	1
Lam, CWK	1
Liu, X	2
Liu, Y	12
Liu, H	2
Li, H	1
Yang, J	3
Hu, P	2
Xiao, X	1
Liu, D	2
Gao, B	1
Gao, W	1
Wan, H	1
Xu, F	1
Zhou, R	1
Zhang, X	3
Ji, Q	3
Kim, HJ	1
Jeong, IK	1
Hur, KY	1
Kim, SK	1
Noh, JH	1
Chun, SW	1
Kang, ES	1
Rhee, EJ	1
Choi, SH	1
Terry, D	1
Eads, AV	1
Pan, Y	1
Yang, H	1
Jin, J	1
Ruan, L	1
Hu, L	1
Chen, L	2
Takeshita, Y	2
Tanaka, T	2
Takayama, H	2
Kita, Y	2
Goto, H	2
Nakano, Y	2
Saito, Y	2
Takamura, T	3
Siboto, A	2
Akinnuga, AM	2
Khumalo, B	2
Ismail, MB	2
Booysen, IN	2
Sibiya, NH	2
Ngubane, P	2
Khathi, A	2
Nishimura, R	3
Osonoi, T	2
Koike, Y	1
Miyata, K	1
Shimasaki, Y	1
Hung, CT	1
Liu, JS	1
Cheng, CY	1
Chung, CH	1
Chiang, CP	1
Chien, WC	1
Wang, WM	1
Sharma, A	4
Vaduganathan, M	1
Bakris, GL	12
Cannon, CP	15
Dicembrini, I	2
Nreu, B	1
Montereggi, C	1
Mannucci, E	3
Monami, M	2
Nishida, Y	1
Takahashi, Y	1
Tezuka, K	1
Akimoto, H	1
Nakayama, T	1
Asai, S	1
Zafar, M	1
Shahbaz, M	1
Hawley, I	1
Rahmani, MJ	1
Elharram, M	1
White, W	1
Shestakova, MV	1
Shestakova, EA	1
Kachko, VA	1
Ueki, K	3
Tanizawa, Y	2
Nakamura, J	3
Yamada, Y	6
Inagaki, N	6
Watada, H	3
Shimomura, I	5
Miyoshi, H	2
Abiko, A	1
Katagiri, H	1
Hayashi, M	1
Shimada, A	1
Naruse, K	1
Fujimoto, S	1
Fujiwara, M	1
Shikata, K	1
Okada, Y	3
Araki, E	1
Yamazaki, T	2
Kadowaki, T	2
Morimoto, K	1
Sasaki, M	2
Oikawa, E	1
Abe, M	2
Kikuchi, T	1
Ishii, M	1
Ogihara, T	1
Tomita, M	1
Li, Q	2
Deng, X	1
Jiang, N	1
Meng, L	1
Xing, J	1
Jiang, W	1
Xu, Y	1
Jensterle, M	1
Goricar, K	1
Janez, A	1
Lingvay, I	1
Kaneko, M	1
Narukawa, M	1
Kaku, K	16
Sano, H	5
Seki, Y	2
Kuroda, S	5
Kurozumi, A	2
Arao, T	2
Kobayashi, T	1
Masuda, D	1
Yamashita, S	1
Tanaka, Y	2
Tosaki, T	1
Kamiya, H	1
Yamamoto, Y	1
Himeno, T	1
Kato, Y	1
Kondo, M	1
Inagaki, A	1
Tsubonaka, K	1
Oshiro, C	1
Katayama, T	1
Hayasaki, T	1
Nakaya, Y	1
Fujiyoshi, H	1
Hwang, YC	1
Morrow, DA	3
Bergenstal, R	2
Heller, S	3
Cushman, W	1
Oita, M	1
Ono, K	1
Nakamura, A	1
Cho, KY	1
Nomoto, H	1
Yamamoto, K	2
Omori, K	1
Manda, N	1
Kurihara, Y	1
Aoki, S	1
Atsumi, T	1
Takayanagi, R	1
Uchida, T	1
Kimura, K	2
Negro, R	1
Greco, EL	1
Greco, G	1
Heller, SR	5
Howitt, H	1
Khunti, K	1
Bergenstal, RM	7
Cavender, MA	2
Massaro, JM	1
Mehta, CR	8
Cushman, WC	11
Baksh, SN	1
McAdams-DeMarco, M	1
Segal, JB	1
Alexander, GC	1
Ishida, K	2
Umeda, Y	2
Song, L	1
Yao, X	1
Wu, Y	1
Zhao, Q	1
Jiang, J	1
Shi, C	1
Ma, X	1
Zhou, H	1
Takahara, M	2
Shiraiwa, T	3
Katakami, N	3
Maeno, Y	1
Shiraiwa, Y	1
Yoshida, Y	1
Matsuoka, TA	2
Sano, M	1
Jalil, F	1
Kishimoto, S	1
Kinoshita, Y	1
Matsumoto, T	1
Maruhashi, T	1
Kajikawa, M	1
Matsui, S	2
Hashimoto, H	1
Takaeko, Y	1
Kihara, Y	1
Chayama, K	1
Goto, C	1
Mohamad Yusoff, F	1
Nakashima, A	1
Noma, K	1
Higashi, Y	1
Ito, H	2
Ando, S	1
Tsugami, E	1
Araki, R	1
Kusano, E	1
Matsumoto, S	2
Uemura, K	1
Nishio, S	1
Antoku, S	1
Yamasaki, T	1
Mori, T	1
Togane, M	1
Hu, J	1
Yang, C	1
Wang, H	2
Li, J	1
Tan, X	1
Wang, J	1
Zhang, B	2
Zhao, Y	1
Meguro, S	1
Itoh, H	2
Shimizu, K	1
Achira, M	1
Pratley, R	1
Fleck, P	10
Munsaka, M	1
Hisada, M	1
Wilson, C	13
Menon, V	3
Ayaori, M	1
Iwakami, N	1
Uto-Kondo, H	1
Sato, H	1
Komatsu, T	2
Iizuka, M	1
Takiguchi, S	1
Yakushiji, E	1
Nakaya, K	1
Yogo, M	1
Ogura, M	1
Takase, B	1
Murakami, T	1
Ikewaki, K	1
Rosenstock, J	3
Bond, T	1
Masuda, K	1
Aoki, K	1
Kamiko, K	1
Takihata, M	1
Ito, Y	1
Nagakura, M	1
Kawasaki, S	1
Akema, N	1
Hasegawa, M	1
Nakajima, S	1
Shinoda, K	1
Toumura, S	1
Tsunoda, S	1
Enomoto, H	1
Shimotomai, H	1
Terauchi, Y	1
Charbonnel, B	1
Schweizer, A	2
Dejager, S	2
Nakamura, Y	1
Inagaki, M	1
Shimizu, T	1
Fujita, K	1
Inoue, M	1
Gotoh, H	1
Oguchi, K	1
Goto, Y	1
Sakata, K	2
Hayakawa, M	2
Yano, Y	2
Tamaki, N	1
Yokota, N	1
Eto, T	1
Watanabe, R	1
Hirayama, N	1
Matsuo, T	2
Kuroki, K	1
Sagara, S	1
Mishima, O	1
Koga, M	1
Nagata, N	1
Nishino, Y	1
Kitamura, K	1
Kario, K	1
Takeuchi, M	1
Yamagishi, S	1
Nissen, SE	5
Perez, AT	2
Fleck, PR	11
Kupfer, S	8
Lim, GB	1
Greenhill, C	1
Capuano, A	1
Sportiello, L	1
Maiorino, MI	1
Rossi, F	1
Giugliano, D	1
Esposito, K	1
Mitka, M	1
Fujita, H	1
Taniai, H	1
Murayama, H	1
Ohshiro, H	1
Hayashi, H	1
Sato, S	1
Kikuchi, N	1
Komatsu, K	2
Narita, T	1
Jarvis, CI	1
Cabrera, A	1
Charron, D	1
Ndefo, UA	1
Okoli, O	1
Erowele, G	1
Pratley, RE	6
Van Raalte, DH	1
van Genugten, RE	1
Eliasson, B	2
Möller-Goede, DL	1
Mari, A	1
Tura, A	1
Taskinen, MR	2
Smith, U	2
Diamant, M	2
Pan, CY	1
Li, WH	1
Zeng, JE	1
Li, CJ	1
Yang, JK	1
Ji, QH	1
Lu, JM	1
Lü, XF	1
Li, XF	1
Qu, S	2
Xu, XJ	1
Xue, YM	1
Li, L	3
Jiang, ZS	1
Zheng, BZ	1
Bu, RF	1
Han, P	3
Liu, JD	1
Peng, YD	1
Liu, XM	1
Liu, ZM	1
Yan, L	2
Lei, MX	1
Li, XJ	1
Song, QH	1
Shi, BY	1
Gu, W	2
Li, ZF	1
Standl, E	2
Sakai, Y	1
Suzuki, A	1
Mugishima, K	1
Sumi, Y	1
Otsuka, Y	1
Otsuka, T	1
Ohno, D	1
Murasawa, T	1
Tsuruoka, S	1
Marino, AB	1
Cole, SW	1
Tibaldi, JM	1
Kaneto, H	2
Mullard, A	1
Garber, AJ	1
Onouchi, H	2
Funao, N	1
Cummings, BP	1
Bettaieb, A	1
Graham, JL	1
Stanhope, K	1
Haj, FG	1
Havel, PJ	1
Seino, Y	7
Yabe, D	2
Doggrell, SA	1
Dimmitt, SB	1
Davis, TM	1
Filippatos, TD	1
Athyros, VG	1
Elisaf, MS	1
Gallwitz, B	2
Nitschmann, S	1
Said, S	1
Nwosu, AC	1
Mukherjee, D	1
Hernandez, GT	1
Lai, ZW	1
Li, C	4
Liu, J	4
Kong, L	1
Wen, X	1
Sun, H	1
Violini, R	1
Vigili de Kreutzenberg, S	1
Del Prato, S	2
Camisasca, R	1
Takebayashi, K	1
Sakurai, S	1
Suzuki, T	1
Hori, K	1
Terasawa, T	1
Naruse, R	1
Hara, K	1
Suetsugu, M	1
Tsuchiya, T	1
Aoki, H	1
Hamasaki, T	1
Shuutou, H	1
Inukai, T	1
Mori, M	1
Kanoo, T	1
Katou, M	3
Kutoh, E	4
Kaneoka, N	1
Hirate, M	3
Clifton, P	1
Maezawa, H	1
Scheen, AJ	4
Zhao, H	1
Pugazhenthi, S	1
Qin, L	1
Bouchard, R	1
Schnell, O	1
Lam, H	1
Cai, Y	1
Lydic, TA	1
Turkette, T	1
Reid, GE	1
Olson, LK	1
Nagai, Y	1
Koska, J	1
Sands, M	1
Burciu, C	1
Reaven, P	1
Keating, GM	1
Saisho, Y	2
McKeage, K	1
Kusunoki, M	1
Sato, D	1
Nakamura, T	1
Oshida, Y	1
Tsutsui, H	1
Natsume, Y	1
Tsutsumi, K	1
Miyata, T	1
Wada, A	2
Chen, XW	1
He, ZX	1
Zhou, ZW	1
Yang, T	2
Yang, YX	1
Duan, W	1
Zhou, SF	1
Igeta, M	1
Ohira, T	1
Hirshberg, B	1
Katz, A	1
Mizushige, T	1
Kobori, H	1

Trial	Phase	Enrollment	Study Type	Start Date	Status
Efficacy and Safety of Alogliptin vs. Acarbose in Chinese T2DM Patients With High CV Risk or CHD Treated With Aspirin and Inadequately Controlled With Metformin Monotherapy or Drug Naive: A Multicenter, Randomized, Open Label, Prospective Study[NCT03794336]	Phase 4	1,293 participants (Actual)	Interventional	2019-06-29	Completed
An Exploratory Study to Evaluate the Effects of Trelagliptin and Alogliptin by CGM on Glucose Variability for One Week in Patients With Type 2 Diabetes Mellitus[NCT02771093]	Phase 4	27 participants (Actual)	Interventional	2016-09-08	Completed
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Cardiovascular Outcomes Following Treatment With Alogliptin in Addition to Standard of Care in Subjects With Type 2 Diabetes and Acute Coronary Syndrome[NCT00968708]	Phase 3	5,380 participants (Actual)	Interventional	2009-09-30	Completed
Effect of a Quadruple Therapy on Pancreatic Islet Function, Insulin Resistance and Cardiovascular Function in Patients With Mixed Prediabetes and Obesity: Randomized Clinical Trial[NCT04131582]	Phase 3	34 participants (Anticipated)	Interventional	2019-09-01	Recruiting
Treatment Preference for Weekly DPP-4 Inhibitors Versus Daily DPP-4 Inhibitors in Patients With Type 2 Diabetes Mellitus[NCT03231709]	Phase 4	60 participants (Actual)	Interventional	2017-08-18	Completed
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Determine the Efficacy and Safety of Alogliptin Plus Metformin, Alogliptin Alone, or Metformin Alone in Subjects With Type 2 Diabetes[NCT01023581]	Phase 3	784 participants (Actual)	Interventional	2009-11-30	Completed
A Phase 3 Study to Investigate the Efficacy and Safety of SYR-322 When Used in Combination With Insulin Preparation in Subjects With Type 2 Diabetes in Japan[NCT01521962]	Phase 3	67 participants (Actual)	Interventional	2012-02-29	Completed
[NCT01632007]	Phase 3	245 participants (Anticipated)	Interventional	2012-05-01	Completed
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Determine the Efficacy and Safety of SYR110322 (SYR-322) Compared With Placebo in Subjects With Type 2 Diabetes[NCT00286455]	Phase 3	329 participants (Actual)	Interventional	2006-02-28	Completed
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Determine the Efficacy and Safety of SYR110322 (SYR-322) When Used in Combination With a Sulfonylurea in Subjects With Type 2 Diabetes[NCT00286468]	Phase 3	500 participants (Actual)	Interventional	2006-04-30	Completed
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Determine the Efficacy and Safety of SYR110322 (SYR-322) When Used in Combination With Metformin in Subjects With Type 2 Diabetes[NCT00286442]	Phase 3	527 participants (Actual)	Interventional	2006-03-31	Completed
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Determine the Efficacy and Safety of SYR110322 (SYR-322) When Used in Combination With Pioglitazone in Subjects With Type 2 Diabetes Mellitus[NCT00286494]	Phase 3	493 participants (Actual)	Interventional	2006-02-28	Completed
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Determine the Efficacy and Safety of SYR110322 (SYR-322) When Used in Combination With Insulin in Subjects With Type 2 Diabetes[NCT00286429]	Phase 3	390 participants (Actual)	Interventional	2006-02-28	Completed
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Comparison Study to Determine the Efficacy and Safety of SYR110322 in Patients With Type 2 Diabetes, Who Are Either Receiving No Current Treatment or Currently Treated With Diet and Exercise, Sul[NCT00755846]	Phase 2	265 participants (Actual)	Interventional	2005-03-31	Completed
A Multicenter, Double-Blind Study to Determine the Efficacy and Safety of SYR-322 Plus Pioglitazone HCl (Actos®), SYR-322 Alone or Pioglitazone HCl Alone in Subjects With Type 2 Diabetes[NCT00395512]	Phase 3	655 participants (Actual)	Interventional	2006-11-30	Completed
A Multicenter, Randomized, Double-Blind Study to Determine the Efficacy and Safety of the Addition of SYR-322 25 mg Versus Dose Titration From 30 mg to 45 mg of Pioglitazone HCl (ACTOS®) in Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Contro[NCT00432276]	Phase 3	803 participants (Actual)	Interventional	2007-01-31	Completed
A Phase 2/3, Double-blind, Randomized, Placebo-controlled, Parallel-group, Multicenter Study to Determine the Efficacy and Safety of SYR-322 When Used in Combination With α-glucosidase Inhibitor in Subjects With Type 2 Diabetes in Japan[NCT01263483]	Phase 2/Phase 3	230 participants (Actual)	Interventional	2007-01-31	Completed
A Long-term, Open-label Extension Study to Investigate the Long-term Safety of SYR-322 When Used in Combination With α-glucosidase Inhibitor in Subjects With Type 2 Diabetes in Japan[NCT01263509]	Phase 2/Phase 3	179 participants (Actual)	Interventional	2007-06-30	Completed
DPP-4 Inhibitors in Patients With Type 2 Diabetes and Acute Myocardial Infarction:Effects on Platelet Function[NCT02377388]	Phase 3	74 participants (Actual)	Interventional	2017-02-07	Completed
Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Comparing SYR-322 Alone and Combination SYR-322 With Pioglitazone Versus Placebo on Postprandial Lipids in Subjects With Type 2 Diabetes[NCT00655863]	Phase 3	71 participants (Actual)	Interventional	2007-07-31	Completed
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Determine the Efficacy and Safety of the Combination of SYR-322 (SYR110322) and Pioglitazone HCl (ACTOS®), in Subjects With Type 2 Diabetes[NCT00328627]	Phase 3	1,554 participants (Actual)	Interventional	2006-05-31	Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Intervention	Participants (Count of Participants)
Trelagliptin 100 mg	1
Alogliptin 25 mg	2

Change from baseline in AUC for blood glucose levels at each time points was calculated. (NCT02771093)
Timeframe: Baseline, up to 28 days

Change From Baseline in AUC for Blood Glucose During Periods When Blood Glucose Levels is Less Than 70 mg/dL (Hypoglycemia)

Intervention	mg·min/dL (Mean)
	D2W3	D3W3	D4W3	D5W3	D6W3	D7W3	D8W3
Alogliptin 25 mg	-4828.9	-3594.8	-4565.6	-5023.4	-4526.4	-4097.5	-4302.9
Trelagliptin 100 mg	-2340.4	-2348.4	-3723.2	-4017.8	-2408.2	-1837.6	-2438.5

Change from baseline in AUC for blood glucose during periods when blood glucose levels was less than 70 mg/dL at each time points was calculated. (NCT02771093)
Timeframe: Baseline, up to 28 days

Change From Baseline in AUC for Blood Glucose During Periods When Blood Glucose Levels Reached 110 mg/dL (Hypoglycemia)

Intervention	mg·min/dL (Mean)
	D2W3	D3W3	D4W3	D5W3	D6W3	D7W3	D8W3
Alogliptin 25 mg	0.4	0.0	13.4	26.9	0.0	0.0	0.0
Trelagliptin 100 mg	-31.2	-43.0	-42.3	-30.5	-39.8	-43.0	-43.0

Change from baseline in AUC for blood glucose during periods when blood glucose levels reached 110 mg/dL at each time points was calculated. (NCT02771093)
Timeframe: Baseline, up to 28 days

Change From Baseline in AUC for Blood Glucose During Periods When Blood Glucose Levels Reached 140 mg/dL (Hyperglycemia)

Intervention	mg·min/dL (Mean)
	D2W3	D3W3	D4W3	D5W3	D6W3	D7W3	D8W3
Alogliptin 25 mg	-4735.1	-3742.8	-4576.9	-4812.0	-4592.1	-4169.3	-4335.7
Trelagliptin 100 mg	-2263.8	-2479.2	-3755.3	-3845.6	-2581.9	-2184.1	-2634.2

Change from baseline in AUC for blood glucose during periods when blood glucose levels reached 140 mg/dL at each time points was calculated. (NCT02771093)
Timeframe: Baseline, up to 28 days

Change From Baseline in AUC for Blood Glucose During Periods When Blood Glucose Levels Reached 160 mg/dL (Hyperglycemia)

Intervention	mg·min/dL (Mean)
	D2W3	D3W3	D4W3	D5W3	D6W3	D7W3	D8W3
Alogliptin 25 mg	-4021.4	-3378.3	-4119.9	-4230.4	-3840.0	-3566.4	-3667.1
Trelagliptin 100 mg	-1935.9	-2001.2	-2978.2	-2981.5	-2550.5	-1946.5	-2043.5

Change from baseline in AUC for blood glucose during periods when blood glucose levels reached 160 mg/dL at each time points was calculated. (NCT02771093)
Timeframe: Baseline, up to 28 days

Change From Baseline in AUC for Blood Glucose During Periods When Blood Glucose Levels Reached 180 mg/dL (Hyperglycemia)

Intervention	mg·min/dL (Mean)
	D2W3	D3W3	D4W3	D5W3	D6W3	D7W3	D8W3
Alogliptin 25 mg	-3075.8	-2767.3	-3273.0	-3384.5	-2990.8	-2768.9	-2818.8
Trelagliptin 100 mg	-1458.0	-1702.0	-2335.8	-2171.8	-2031.0	-1636.5	-1603.9

Change from baseline in AUC for blood glucose during periods when blood glucose levels reached 180 mg/dL at each time points was calculated. (NCT02771093)
Timeframe: Baseline, up to 28 days

Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (110 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal

Intervention	mg·min/dL (Mean)
	D2W3	D3W3	D4W3	D5W3	D6W3	D7W3	D8W3
Alogliptin 25 mg	-2247.9	-2086.7	-2352.2	-2492.3	-2109.1	-1976.3	-2009.8
Trelagliptin 100 mg	-989.9	-1332.7	-1685.1	-1486.5	-1449.4	-1264.2	-1166.8

Change from baseline in AUC for blood glucose when specific blood glucose levels (110 mg/dL) were observed during the 3 hour time period after breakfast, lunch and evening meal at each time points was calculated. (NCT02771093)
Timeframe: Baseline, up to 28 days

Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (140 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal

Intervention	mg·min/dL (Mean)
	D2W3 after breakfast	D3W3 after breakfast	D4W3 after breakfast	D5W3 after breakfast	D6W3 after breakfast	D7W3 after breakfast	D8W3 after breakfast	D2W3 after lunch	D3W3 after lunch	D4W3 after lunch	D5W3 after lunch	D6W3 after lunch	D7W3 after lunch	D8W3 after lunch	D2W3 after evening meal	D3W3 after evening meal	D4W3 after evening meal	D5W3 after evening meal	D6W3 after evening meal	D7W3 after evening meal	D8W3 after evening meal
Alogliptin 25 mg	-1052.7	-1030.9	-958.9	-1319.8	-832.5	-966.3	-1024.8	-1131.4	-941.9	-701.1	-1065.4	-534.4	-488.7	-923.5	-800.5	-1023.6	-1228.5	-756.1	-1144.2	-669.9	-577.0
Trelagliptin 100 mg	-203.7	-662.6	-1024.6	-97.2	-696.1	-573.8	-399.0	-669.0	-500.1	-468.2	-793.5	-798.5	-320.4	-521.3	-1079.4	-1273.0	-1359.6	-1351.4	-1199.9	-884.2	-1142.0

Change from baseline in AUC for blood glucose when specific blood glucose levels (140 mg/dL) were observed during the 3 hour time period after breakfast, lunch and evening meal at each time points was calculated. (NCT02771093)
Timeframe: Baseline, up to 28 days

Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (160 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal

Intervention	mg·min/dL (Mean)
	D2W3 after breakfast	D3W3 after breakfast	D4W3 after breakfast	D5W3 after breakfast	D6W3 after breakfast	D7W3 after breakfast	D8W3 after breakfast	D2W3 after lunch	D3W3 after lunch	D4W3 after lunch	D5W3 after lunch	D6W3 after lunch	D7W3 after lunch	D8W3 after lunch	D2W3 after evening meal	D3W3 after evening meal	D4W3 after evening meal	D5W3 after evening meal	D6W3 after evening meal	D7W3 after evening meal	D8W3 after evening meal
Alogliptin 25 mg	-981.2	-926.1	-801.6	-1178.0	-791.8	-910.1	-951.6	-1079.1	-845.4	-648.1	-970.0	-517.0	-458.3	-867.4	-637.6	-862.0	-1016.8	-613.7	-966.4	-586.4	-535.0
Trelagliptin 100 mg	-218.5	-510.2	-886.4	-21.3	-559.8	-457.4	-348.5	-588.5	-489.7	-429.3	-725.5	-707.9	-294.9	-474.7	-950.8	-1077.3	-1147.1	-1147.5	-1030.6	-822.3	-964.8

Change from baseline in AUC for blood glucose when specific blood glucose levels (160 mg/dL) were observed during the 3 hour time period after breakfast, lunch and evening meal at each time points was calculated. (NCT02771093)
Timeframe: Baseline, up to 28 days

Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (180 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal

Intervention	mg·min/dL (Mean)
	D2W3 after breakfast	D3W3 after breakfast	D4W3 after breakfast	D5W3 after breakfast	D6W3 after breakfast	D7W3 after breakfast	D8W3 after breakfast	D2W3 after lunch	D3W3 after lunch	D4W3 after lunch	D5W3 after lunch	D6W3 after lunch	D7W3 after lunch	D8W3 after lunch	D2W3 after evening meal	D3W3 after evening meal	D4W3 after evening meal	D5W3 after evening meal	D6W3 after evening meal	D7W3 after evening meal	D8W3 after evening meal
Alogliptin 25 mg	-829.2	-770.4	-609.9	-981.3	-696.8	-760.4	-806.3	-890.4	-705.5	-552.5	-811.9	-469.7	-384.6	-730.1	-507.4	-671.1	-808.9	-508.3	-759.6	-504.1	-460.2
Trelagliptin 100 mg	-164.5	-377.8	-759.4	25.6	-405.5	-356.6	-273.4	-448.1	-462.2	-389.7	-579.4	-534.1	-249.9	-350.8	-730.5	-825.2	-914.5	-887.5	-809.5	-742.3	-763.4

Change from baseline in AUC for blood glucose when specific blood glucose levels (180 mg/dL) were observed during the 3 hour time period after breakfast, lunch and evening meal at each time points was calculated. (NCT02771093)
Timeframe: Baseline, up to 28 days

Change From Baseline in Maximum Variation of Blood Glucose Levels Between Before and After Breakfast, Lunch, and Evening Meal

Intervention	mg·min/dL (Mean)
	D2W3 after breakfast	D3W3 after breakfast	D4W3 after breakfast	D5W3 after breakfast	D6W3 after breakfast	D7W3 after breakfast	D8W3 after breakfast	D2W3 after lunch	D3W3 after lunch	D4W3 after lunch	D5W3 after lunch	D6W3 after lunch	D7W3 after lunch	D8W3 after lunch	D2W3 after evening meal	D3W3 after evening meal	D4W3 after evening meal	D5W3 after evening meal	D6W3 after evening meal	D7W3 after evening meal	D8W3 after evening meal
Alogliptin 25 mg	-660.1	-592.9	-375.6	-776.3	-556.5	-578.2	-603.6	-626.6	-521.1	-404.1	-589.9	-354.6	-293.6	-546.4	-375.9	-484.4	-597.2	-427.8	-552.4	-374.5	-346.5
Trelagliptin 100 mg	-90.7	-241.2	-632.2	36.5	-272.2	-264.2	-214.8	-300.3	-383.8	-307.0	-430.4	-353.5	-184.2	-234.0	-507.6	-592.4	-662.4	-641.9	-598.8	-612.6	-555.4

Change from baseline in maximum variation of glucose levels between before and after breakfast, lunch and evening meal at each time points was calculated. (NCT02771093)
Timeframe: Baseline, up to 28 days

Change From Baseline in Mean 24-hour Blood Glucose Levels

Intervention	mg/dL (Mean)
	D2W3 between before/after breakfast	D3W3 between before/after breakfast	D4W3 between before/after breakfast	D5W3 between before/after breakfast	D6W3 between before/after breakfast	D7W3 between before/after breakfast	D8W3 between before/after breakfast	D2W3 between before/after lunch	D3W3 between before/after lunch	D4W3 between before/after lunch	D5W3 between before/after lunch	D6W3 between before/after lunch	D7W3 between before/after lunch	D8W3 between before/after lunch	D2W3 between before/after evening meal	D3W3 between before/after evening meal	D4W3 between before/after evening meal	D5W3 between before/after evening meal	D6W3 between before/after evening meal	D7W3 between before/after evening meal	D8W3 between before/after evening meal
Alogliptin 25 mg	-28.9	-35.4	-42.1	-25.5	-29.8	-33.3	-34.5	-35.5	-29.5	-6.2	-31.2	-13.1	-14.9	-29.1	-15.6	-21.8	-24.2	-5.2	-24.6	-4.4	-6.6
Trelagliptin 100 mg	-13.9	-47.4	-41.2	-7.0	-38.6	-36.4	-36.2	-30.2	-34.5	-23.8	-34.8	-37.0	-12.7	-15.6	-37.8	-49.1	-42.6	-31.5	-41.9	-33.6	-39.3

Change from baseline in mean 24-hour blood glucose levels at each time points was calculated. (NCT02771093)
Timeframe: Baseline, up to 28 days

Change From Baseline in Mean Amplitude Glycemic Excursions (MAGE)

Intervention	mg/dL (Mean)
	D2W3	D3W3	D4W3	D5W3	D6W3	D7W3	D8W3
Alogliptin 25 mg	-16.77	-12.46	-15.85	-17.46	-15.79	-14.23	-14.94
Trelagliptin 100 mg	-8.14	-8.15	-13.12	-13.95	-8.37	-6.38	-8.46

Change from baseline in MAGE at each time points was calculated. (NCT02771093)
Timeframe: Baseline, up to 28 days

Change From Baseline in Mean Daytime Blood Glucose Levels

Intervention	mg/dL (Mean)
	D2W3	D3W3	D4W3	D5W3	D6W3	D7W3	D8W3
Alogliptin 25 mg	-47.25	-52.75	-44.67	-50.22	-34.82	-37.18	-41.38
Trelagliptin 100 mg	-28.42	-33.72	-36.08	-23.12	-38.05	-25.74	-24.26

Change from baseline in mean daytime blood glucose levels at each time points was calculated. (NCT02771093)
Timeframe: Baseline, up to 28 days

Change From Baseline in Mean Nocturnal Blood Glucose Levels

Intervention	mg/dL (Mean)
	D2W3	D3W3	D4W3	D5W3	D6W3	D7W3	D8W3
Alogliptin 25 mg	-20.38	-17.21	-21.80	-22.54	-19.34	-16.92	-19.78
Trelagliptin 100 mg	-11.08	-12.48	-18.42	-19.53	-14.27	-10.86	-12.90

Change from baseline in mean nocturnal blood glucose levels at each time points was calculated. (NCT02771093)
Timeframe: Baseline, up to 28 days

Change From Baseline in Peak Postprandial Glucose Levels During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal

Intervention	mg/dL (Mean)
	D2W3	D3W3	D4W3	D5W3	D6W3	D7W3	D8W3
Alogliptin 25 mg	-10.69	-3.38	-3.76	-6.43	-7.98	-8.59	-5.96
Trelagliptin 100 mg	-2.65	0.52	-3.17	-4.09	5.55	3.86	1.06

Change from baseline in peak postprandial glucose levels during the 3 hour time period after breakfast, lunch and evening meal at each time points was calculated. (NCT02771093)
Timeframe: Baseline, up to 28 days

Change From Baseline in Time During Periods When Blood Glucose Levels Reached 140 mg/dL (Hyperglycemia)

Intervention	mg/dL (Mean)
	D2W3 after breakfast	D3W3 after breakfast	D4W3 after breakfast	D5W3 after breakfast	D6W3 after breakfast	D7W3 after breakfast	D8W3 after breakfast	D2W3 after lunch	D3W3 after lunch	D4W3 after lunch	D5W3 after lunch	D6W3 after lunch	D7W3 after lunch	D8W3 after lunch	D2W3 after evening meal	D3W3 after evening meal	D4W3 after evening meal	D5W3 after evening meal	D6W3 after evening meal	D7W3 after evening meal	D8W3 after evening meal
Alogliptin 25 mg	-35.6	-29.1	-29.0	-41.1	-24.2	-29.6	-31.4	-40.8	-35.1	-16.6	-41.6	-18.7	-18.1	-33.6	-21.3	-21.6	-32.7	-15.6	-33.8	-13.9	-15.9
Trelagliptin 100 mg	-11.3	-35.4	-39.4	-4.9	-28.6	-23.7	-16.6	-26.9	-25.9	-21.9	-34.8	-32.7	-11.5	-17.7	-40.6	-44.5	-45.8	-40.6	-41.5	-32.3	-42.2

Change from baseline in cumulative time during periods when blood glucose levels reached 140 mg/dL at each time points was calculated. (NCT02771093)
Timeframe: Baseline, up to 28 days

Change From Baseline in Time During Periods When Blood Glucose Levels Reached 160 mg/dL (Hyperglycemia)

Intervention	min (Mean)
	D2W3	D3W3	D4W3	D5W3	D6W3	D7W3	D8W3
Alogliptin 25 mg	-212.5	-147.1	-166.1	-163.2	-193.2	-182.1	-198.6
Trelagliptin 100 mg	-116.9	-105.0	-163.8	-192.3	-114.2	-96.9	-133.8

Change from baseline in cumulative time during periods when blood glucose levels reached 160 mg/dL at each time points was calculated. (NCT02771093)
Timeframe: Baseline, up to 28 days

Change From Baseline in Time During Periods When Blood Glucose Levels Reached 180 mg/dL (Hyperglycemia)

Intervention	min (Mean)
	D2W3	D3W3	D4W3	D5W3	D6W3	D7W3	D8W3
Alogliptin 25 mg	-229.3	-173.2	-234.3	-236.8	-232.9	-213.2	-225.4
Trelagliptin 100 mg	-134.2	-75.0	-167.7	-200.0	-153.1	-93.5	-115.0

Change from baseline in cumulative time during periods when blood glucose levels reached 180 mg/dL at each time points was calculated. (NCT02771093)
Timeframe: Baseline, up to 28 days

Changes From Baseline in the SD of Daytime Blood Glucose Values

Intervention	min (Mean)
	D2W3	D3W3	D4W3	D5W3	D6W3	D7W3	D8W3
Alogliptin 25 mg	-210.7	-167.1	-236.4	-225.4	-216.8	-194.3	-193.2
Trelagliptin 100 mg	-91.2	-117.3	-167.3	-153.1	-137.7	-94.2	-105.0

Change from baseline in SD of daytime blood glucose values at each time points was calculated. (NCT02771093)
Timeframe: Baseline, up to 28 days

Changes From Baseline in the SD of Nocturnal Blood Glucose Values

Intervention	mg/dL (Mean)
	D2W3	D3W3	D4W3	D5W3	D6W3	D7W3	D8W3
Alogliptin 25 mg	-13.28	-13.12	-10.98	-12.54	-10.44	-9.49	-10.81
Trelagliptin 100 mg	-9.78	-12.82	-11.98	-10.88	-11.94	-8.13	-6.49

Change from baseline in SD of nocturnal blood glucose values at each time points was calculated. (NCT02771093)
Timeframe: Baseline, up to 28 days

Changes From Baseline in the Standard Deviation (SD) of 24-hour Blood Glucose Values

Intervention	mg/dL (Mean)
	D2W3	D3W3	D4W3	D5W3	D6W3	D7W3	D8W3
Alogliptin 25 mg	-2.45	-9.76	-7.86	-5.21	-8.23	-8.01	-6.64
Trelagliptin 100 mg	-0.71	-3.55	-4.06	-2.96	-5.67	-5.25	-2.93

Changes in the SD of 24-hour blood glucose values (mg/dL) for each 7-day period between Week 3 and Week 4 (between Day 2 on Week 3 [Day 22] and Day 8 on Week 3 [Day 28]) of the treatment period, calculated from the value at the start of the observation period. (NCT02771093)
Timeframe: Baseline, up to 28 days

Standard Deviation (SD) of 24-hour Blood Glucose Values

Percentage of Participants With Primary Major Adverse Cardiac Events (MACE)

Intervention	mg/dL (Mean)
	Day(D) 2 Week(W) 3	D3W3	D4W3	D5W3	D6W3	D7W3	D8W3
Alogliptin 25 mg	-13.04	-15.24	-12.91	-13.28	-11.94	-10.90	-11.63
Trelagliptin 100 mg	-7.51	-11.76	-11.71	-9.89	-12.75	-9.50	-7.35

Intervention	mg/dL (Mean)
	Baseline	D2W3	D3W3	D4W3	D5W3	D6W3	D7W3	D8W3
Alogliptin 25 mg	40.44	27.41	25.20	27.54	27.16	28.51	29.54	28.81
Trelagliptin 100 mg	38.18	30.68	26.42	26.48	28.29	25.44	28.68	30.84

Primary Major Adverse Cardiac Events were defined as a composite of cardiovascular death, nonfatal myocardial infarction and nonfatal stroke; these events were adjudicated by an independent cardiovascular endpoints committee. (NCT00968708)
Timeframe: From randomization until the adjudication cut-off date of May 31 2013 (maximum time on study was 41 months).

Percentage of Participants With Secondary Major Adverse Cardiac Events (MACE)

Intervention	percentage of participants (Number)
Placebo	11.8
Alogliptin	11.3

Secondary MACE composite consisted of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, or urgent revascularization due to unstable angina; these events were adjudicated by an independent cardiovascular endpoint committee. (NCT00968708)
Timeframe: From randomization until the adjudication cut-of date of May 31 2013 (maximum time on study was 41 months).

Number of Participants by Their Treatment Preference Using Standardized Questions at the End of Treatment Period

Intervention	percentage of participants (Number)
Placebo	13.4
Alogliptin	12.7

Participants answered standardized questions about their preference of drug therapy for Type 2 Diabetes Mellitus. Participants selected one choice from the following 4 choices; either once-weekly DPP-4 inhibitor or daily DPP-4 inhibitor, once-weekly DPP-4 inhibitor, daily DPP-4 inhibitor, neither once-weekly DPP-4 inhibitor nor daily DPP-4 inhibitor. Reported data was the number of participants with a choice of either trelagliptin (once-weekly DPP-4 inhibitor) or alogliptin (once-daily DPP-4 inhibitor), trelagliptin, alogliptin, neither trelagliptin nor alogliptin. (NCT03231709)
Timeframe: At Week 16

Number of Participants by Their Treatment Preference Using Standardized Questions at the End of Treatment Period by Background Factors

Intervention	Participants (Count of Participants)
	Either Trelagliptin or Alogliptin	Trelagliptin	Alogliptin	Neither Trelagliptin nor Alogliptin
Alogliptin 25 mg + Trelagliptin 100 mg	7	10	13	0
Trelagliptin 100 mg + Alogliptin 25 mg	4	8	18	0

Participants answered standardized questions about their preference of drug therapy for Type 2 Diabetes Mellitus. The preference of drug therapy was categorized by background factors like age (years), gender, height (cm), weight (kg), BMI (kg/m^2), duration of diabetes (years), work status, alcohol intake history, smoking habits, experience of educational hospitalization on DM, presence of cohabiter, percentage of compliance with DPP-4 inhibitors during 4-weeks before the start of treatment period, number of oral drugs per day at the beginning of treatment period (excluding investigational drug), complication of metabolic syndrome, percentage of HbA1c (NGSP is the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) at the time of informed consent. (NCT03231709)
Timeframe: At Week 16

Number of Participants by Their Treatment Preference Using Standardized Questions at the End of Treatment Period by Background Factors (A-T Administered Group)

Intervention	Participants (Count of Participants)
	Age, Min <= - <65	Age, 65 <= - <75	Gender, Male	Gender, Female	Height, Min <= - <150	Height, 150 <= - <160	Height, 160 <= - <170	Height, 170 <= - <=Max	Weight, Min <= - <50.0	Weight, 50.0 <= - <60.0	Weight, 60.0<= - <70.0	Weight, 70.0 <= - <80.0	Weight, 80.0 <= - <=Max	BMI, Min <= - <18.5	BMI, 18.5 <= - <25.0	BMI, 25.0 <= - <=Max	Duration of Diabetes, 3 Years or More	Duration of Diabetes, Less than 3 Years	Work Status, Worker	Work Status, Unemployed	Alcohol Intake History, Regular Drinker	Alcohol Intake History, Occasional Drinker	Alcohol Intake History, Non-Drinker	Had Smoking Habits	Had No Smoking Habits	Had Experience of Educational Hospitalization	Had No Experience of Educational Hospitalization	Presence of Cohabiter, Live alone	Presence of Cohabiter, Living together	Compliance with DPP-4 Inhibitors, 90% or More	Number of Oral Drugs per Day, 1 or 2 Tablet(s)	Number of Oral Drugs per Day, 3 - 5 Tablets	Number of Oral Drugs per Day, 6 Tablets or More	Had Complication of Metabolic Syndrome	Had No Complication of Metabolic Syndrome	HbA1c (NGSP), < 7.0%	HbA1c (NGSP), 7.0%<= - <8.0%	HbA1c (NGSP), 8.0%<=
Alogliptin Preference	16	15	27	4	0	2	14	15	0	5	12	7	7	0	18	13	28	3	22	9	23	0	8	2	29	2	29	4	27	31	13	11	7	14	17	11	14	6
Either Trelagliptin or Alogliptin	9	2	11	0	0	0	1	10	0	0	3	8	0	0	9	2	10	1	9	2	5	2	4	4	7	3	8	1	10	11	1	5	5	4	7	1	7	3
Neither Trelagliptin Nor Alogliptin	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Trelagliptin Preference	13	5	16	2	1	1	9	7	1	5	3	6	3	1	9	8	17	1	16	2	7	3	8	4	14	0	18	3	15	18	7	8	3	4	14	6	8	4

Number of Participants by Their Treatment Preference Using Standardized Questions at the End of Treatment Period by Background Factors (T-A Administered Group)

Intervention	Participants (Count of Participants)
	Age, Min <= - <65	Age, 65 <= - <75	Gender, Male	Gender, Female	Height, 150 <= - <160	Height, 160 <= - <170	Height, 170 <= - <=Max	Weight, 50.0 <= - <60.0	Weight, 60.0<= - <70.0	Weight, 70.0 <= - <80.0	Weight, 80.0 <= - <=Max	BMI, Min <= - <18.5	BMI, 18.5 <= - <25.0	BMI, 25.0 <= - <=Max	Duration of Diabetes, 3 Years or More	Duration of Diabetes, Less than 3 Years	Work Status, Worker	Work Status, Unemployed	Alcohol Intake History, Regular Drinker	Alcohol Intake History, Occasional Drinker	Alcohol Intake History, Non-Drinker	Had Smoking Habits	Had No Smoking Habits	Had Experience of Educational Hospitalization	Had No Experience of Educational Hospitalization	Presence of Cohabiter, Live alone	Presence of Cohabiter, Living together	Compliance with DPP-4 Inhibitors, 90% or More	Number of Oral Drugs per Day, 1 or 2 Tablet(s)	Number of Oral Drugs per Day, 3 - 5 Tablets	Number of Oral Drugs per Day, 6 Tablets or More	Had Complication of Metabolic Syndrome	Had No Complication of Metabolic Syndrome	HbA1c (NGSP), < 7.0%	HbA1c (NGSP), 7.0%<= - <8.0%	HbA1c (NGSP), 8.0%<=
Alogliptin Preference	7	6	12	1	1	3	9	1	7	2	3	0	8	5	13	0	9	4	11	0	2	1	12	1	12	2	11	13	4	6	3	5	8	8	3	2
Either Trelagliptin or Alogliptin	5	2	7	0	0	1	6	0	2	5	0	0	5	2	6	1	5	2	2	1	4	4	3	1	6	1	6	7	0	2	5	3	4	0	6	1
Neither Trelagliptin Nor Alogliptin	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Trelagliptin Preference	8	2	9	1	1	6	3	5	1	2	2	1	5	4	10	0	9	1	3	3	4	2	8	0	10	1	9	10	5	3	2	3	7	2	4	4

Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26

Intervention	Participants (Count of Participants)
	Age, Min <= - <65	Age, 65 <= - <75	Gender, Male	Gender, Female	Height, Min <= - <150	Height, 150 <= - <160	Height, 160 <= - <170	Height, 170 <= - <=Max	Weight, Min <= - <50.0	Weight, 50.0 <= - <60.0	Weight, 60.0<= - <70.0	Weight, 70.0 <= - <80.0	Weight, 80.0 <= - <=Max	BMI, 18.5 <= - <25.0	BMI, 25.0 <= - <=Max	Duration of Diabetes, 3 Years or More	Duration of Diabetes, Less than 3 Years	Work Status, Worker	Work Status, Unemployed	Alcohol Intake History, Regular Drinker	Alcohol Intake History, Occasional Drinker	Alcohol Intake History, Non-Drinker	Had Smoking Habits	Had No Smoking Habits	Had Experience of Educational Hospitalization	Had No Experience of Educational Hospitalization	Presence of Cohabiter, Live alone	Presence of Cohabiter, Living together	Compliance with DPP-4 Inhibitors, 90% or More	Number of Oral Drugs per Day, 1 or 2 Tablet(s)	Number of Oral Drugs per Day, 3 - 5 Tablets	Number of Oral Drugs per Day, 6 Tablets or More	Had Complication of Metabolic Syndrome	Had No Complication of Metabolic Syndrome	HbA1c (NGSP), < 7.0%	HbA1c (NGSP), 7.0%<= - <8.0%	HbA1c (NGSP), 8.0%<=
Alogliptin Preference	9	9	15	3	0	1	11	6	0	4	5	5	4	10	8	15	3	13	5	12	0	6	1	17	1	17	2	16	18	9	5	4	9	9	3	11	4
Either Trelagliptin or Alogliptin	4	0	4	0	0	0	0	4	0	0	1	3	0	4	0	4	0	4	0	3	1	0	0	4	2	2	0	4	4	1	3	0	1	3	1	1	2
Neither Trelagliptin Nor Alogliptin	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Trelagliptin Preference	5	3	7	1	1	0	3	4	1	0	2	4	1	4	4	7	1	7	1	4	0	4	2	6	0	8	2	6	8	2	5	1	1	7	4	4	0

The change from Baseline to Week 26 in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound). (NCT01023581)
Timeframe: Baseline and Week 26.

Change From Baseline in Fasting Plasma Glucose Over Time

Intervention	percentage glycosylated hemoglobin (Least Squares Mean)
Placebo	0.15
Alogliptin 25 QD	-0.52
Alogliptin 12.5 BID	-0.56
Metformin 500 BID	-0.65
Metformin 1000 BID	-1.11
Alogliptin 12.5 BID + Metformin 500 BID	-1.22
Alogliptin 12.5 BID + Metformin 1000 BID	-1.55

The change from Baseline in fasting plasma glucose was assessed at Weeks 1, 2, 4, 8, 12, 16, 20 and 26. Least Squares Means were from an ANCOVA model with treatment and geographic region as fixed effects, and baseline fasting plasma glucose as a covariate. (NCT01023581)
Timeframe: Baseline and Weeks 1, 2, 4, 8, 12, 16, 20 and 26.

Change From Baseline in HbA1c Over Time

Intervention	mg/dL (Least Squares Mean)
	Week 1 (n=102, 103, 94, 95, 104, 101, 109)	Week 2 (n=105, 112, 105, 102, 108, 106, 111)	Week 4 (n=105, 112, 106, 106, 110, 106, 111)	Week 8 (n=105, 112, 106, 106, 110, 106, 112)	Week 12 (n=105, 112, 106, 106, 110, 106, 112)	Week 16 (n=105, 112, 106, 106, 110, 106, 112)	Week 20 (n=105, 112, 106, 106, 110, 106, 112)	Week 26 (n=105, 112, 106, 106, 110, 106, 112)
Alogliptin 12.5 BID	-11.9	-11.6	-16.6	-12.1	-14.7	-14.7	-12.3	-9.7
Alogliptin 12.5 BID + Metformin 1000 BID	-36.3	-43.6	-44.1	-43.8	-44.7	-47.7	-44.6	-45.9
Alogliptin 12.5 BID + Metformin 500 BID	-32.7	-34.5	-37.6	-32.9	-31.6	-35.9	-33.8	-31.7
Alogliptin 25 QD	-3.9	-7.4	-11.5	-10.9	-9.7	-7.1	-9.2	-6.1
Metformin 1000 BID	-23.1	-22.2	-29.0	-30.7	-30.7	-33.5	-35.1	-31.9
Metformin 500 BID	-12.6	-14.5	-16.9	-11.8	-14.0	-13.3	-10.9	-11.5
Placebo	5.7	4.6	7.2	7.1	11.6	10.1	8.7	12.4

"The change from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) was assessed at Weeks 4, 8, 12, 16 and 20.~Least squares means are from an analysis of covariance (ANCOVA) model with treatment and geographic region as fixed effects, and baseline HbA1c as a covariate." (NCT01023581)
Timeframe: Baseline and Weeks 4, 8, 12, 16, and 20.

Change From Baseline in Body Weight (Week 12).

Intervention	percentage glycosylated hemoglobin (Least Squares Mean)
	Week 4 (n=95, 97, 89, 94, 102, 94, 101)	Week 8 (n=102, 104, 104, 103, 108, 102, 111)	Week 12 (n=102, 104, 104, 103, 108, 102, 111)	Week 16 (n=102, 104, 104, 103, 108, 102, 111)	Week 20 (n=102, 104, 104, 103, 108, 102, 111)
Alogliptin 12.5 BID	-0.42	-0.58	-0.62	-0.63	-0.59
Alogliptin 12.5 BID + Metformin 1000 BID	-0.75	-1.17	-1.40	-1.50	-1.54
Alogliptin 12.5 BID + Metformin 500 BID	-0.70	-1.08	-1.22	-1.26	-1.25
Alogliptin 25 QD	-0.34	-0.51	-0.53	-0.58	-0.57
Metformin 1000 BID	-0.58	-0.86	-1.02	-1.09	-1.14
Metformin 500 BID	-0.37	-0.59	-0.68	-0.72	-0.68
Placebo	0.09	0.08	0.12	0.13	0.12

The change between Body Weight measured at week 12 and Body Weight measured at baseline. (NCT00286455)
Timeframe: Baseline and Week 12.

Change From Baseline in Body Weight (Week 20).

Intervention	kg (Least Squares Mean)
Placebo QD	-0.25
Alogliptin 12.5 mg QD	-0.37
Alogliptin 25 mg QD	0.05

The change between Body Weight measured at week 20 and Body Weight measured at baseline. (NCT00286455)
Timeframe: Baseline and Week 20.

Change From Baseline in Body Weight (Week 26).

Intervention	kg (Least Squares Mean)
Placebo QD	-0.17
Alogliptin 12.5 mg QD	-0.18
Alogliptin 25 mg QD	-0.17

The change between Body Weight measured at week 26 or final visit and Body Weight measured at baseline. (NCT00286455)
Timeframe: Baseline and Week 26.

Change From Baseline in Body Weight (Week 8).

Intervention	kg (Least Squares Mean)
Placebo QD	0.18
Alogliptin 12.5 mg QD	-0.09
Alogliptin 25 mg QD	-0.22

The change between Body Weight measured at week 8 and Body Weight measured at baseline. (NCT00286455)
Timeframe: Baseline and Week 8.

Change From Baseline in C-peptide (Week 12).

Intervention	kg (Least Squares Mean)
Placebo QD	-0.36
Alogliptin 12.5 mg QD	0.01
Alogliptin 25 mg QD	-0.03

The change between the value of C-peptide collected at week 12 and C-peptide collected at baseline. (NCT00286455)
Timeframe: Baseline and Week 12.

Change From Baseline in C-peptide (Week 16).

Intervention	ng/mL (Least Squares Mean)
Placebo QD	-0.104
Alogliptin 12.5 mg QD	0.064
Alogliptin 25 mg QD	-0.091

The change between the value of C-peptide collected at week 16 and C-peptide collected at baseline. (NCT00286455)
Timeframe: Baseline and Week 16.

Change From Baseline in C-peptide (Week 20).

Intervention	ng/mL (Least Squares Mean)
Placebo QD	-0.030
Alogliptin 12.5 mg QD	-0.060
Alogliptin 25 mg QD	-0.127

The change between the value of C-peptide collected at week 20 and C-peptide collected at baseline. (NCT00286455)
Timeframe: Baseline and Week 20.

Change From Baseline in C-peptide (Week 26).

Intervention	ng/mL (Least Squares Mean)
Placebo QD	-0.194
Alogliptin 12.5 mg QD	-0.264
Alogliptin 25 mg QD	-0.231

The change between the value of C-peptide collected at week 26 or final visit and C-peptide collected at baseline. (NCT00286455)
Timeframe: Baseline and Week 26.

Change From Baseline in C-peptide (Week 4).

Intervention	ng/mL (Least Squares Mean)
Placebo QD	-0.282
Alogliptin 12.5 mg QD	-0.360
Alogliptin 25 mg QD	-0.279

The change between the value of C-peptide collected at week 4 and C-peptide collected at baseline. (NCT00286455)
Timeframe: Baseline and Week 4.

Change From Baseline in C-peptide (Week 8).

Intervention	ng/mL (Least Squares Mean)
Placebo QD	0.242
Alogliptin 12.5 mg QD	0.026
Alogliptin 25 mg QD	0.088

The change between the value of C-peptide collected at week 8 and C-peptide collected at baseline. (NCT00286455)
Timeframe: Baseline and Week 8.

Change From Baseline in Fasting Plasma Glucose (Week 1).

Intervention	ng/mL (Least Squares Mean)
Placebo QD	-0.014
Alogliptin 12.5 mg QD	0.070
Alogliptin 25 mg QD	0.269

The change between the value of fasting plasma glucose collected at final visit or week 1 and fasting plasma glucose collected at baseline. (NCT00286455)
Timeframe: Baseline and Week 1.

Change From Baseline in Fasting Plasma Glucose (Week 12).

Intervention	mg/dL (Least Squares Mean)
Placebo QD	4.6
Alogliptin 12.5 mg QD	-8.6
Alogliptin 25 mg QD	-14.0

The change between the value of fasting plasma glucose collected at week 12 and fasting plasma glucose collected at baseline. (NCT00286455)
Timeframe: Baseline and Week 12.

Change From Baseline in Fasting Plasma Glucose (Week 16).

Intervention	mg/dL (Least Squares Mean)
Placebo QD	1.2
Alogliptin 12.5 mg QD	-15.3
Alogliptin 25 mg QD	-20.0

The change between the value of fasting plasma glucose collected at week 16 and fasting plasma glucose collected at baseline. (NCT00286455)
Timeframe: Baseline and Week 16.

Change From Baseline in Fasting Plasma Glucose (Week 2).

Intervention	mg/dL (Least Squares Mean)
Placebo QD	5.2
Alogliptin 12.5 mg QD	-14.6
Alogliptin 25 mg QD	-18.2

The change between the value of fasting plasma glucose collected at week 2 and fasting plasma glucose collected at baseline. (NCT00286455)
Timeframe: Baseline and Week 2.

Change From Baseline in Fasting Plasma Glucose (Week 20).

The change between the value of fasting plasma glucose collected at week 20 and fasting plasma glucose collected at baseline. (NCT00286455)
Timeframe: Baseline and Week 20.

Change From Baseline in Fasting Plasma Glucose (Week 26).

The change between the value of fasting plasma glucose collected at week 26 or final visit and fasting plasma glucose collected at baseline. (NCT00286455)
Timeframe: Baseline and Week 26.

Change From Baseline in Fasting Plasma Glucose (Week 4).

The change between the value of fasting plasma glucose collected at week 4 and fasting plasma glucose collected at baseline. (NCT00286455)
Timeframe: Baseline and Week 4.

Change From Baseline in Fasting Plasma Glucose (Week 8).

The change between the value of fasting plasma glucose collected at week 8 and fasting plasma glucose collected at baseline. (NCT00286455)
Timeframe: Baseline and Week 8.

Change From Baseline in Fasting Proinsulin (Week 12).

The change between the value of fasting proinsulin collected at week 12 and fasting proinsulin collected at baseline. (NCT00286455)
Timeframe: Baseline and Week 12.

Change From Baseline in Fasting Proinsulin (Week 16).

The change between the value of fasting proinsulin collected at week 16 and fasting proinsulin collected at baseline. (NCT00286455)
Timeframe: Baseline and Week 16.

Change From Baseline in Fasting Proinsulin (Week 20).

The change between the value of fasting proinsulin collected at week 20 and fasting proinsulin collected at baseline. (NCT00286455)
Timeframe: Baseline and Week 20.

Change From Baseline in Fasting Proinsulin (Week 26).

The change between the value of fasting proinsulin collected at week 26 or final visit and fasting proinsulin collected at baseline. (NCT00286455)
Timeframe: Baseline and Week 26.

Change From Baseline in Fasting Proinsulin (Week 4).

The change between the value of fasting proinsulin collected at week 4 and fasting proinsulin collected at baseline. (NCT00286455)
Timeframe: Baseline and Week 4.

Change From Baseline in Fasting Proinsulin (Week 8).

The change between the value of fasting proinsulin collected at week 8 and fasting proinsulin collected at baseline. (NCT00286455)
Timeframe: Baseline and Week 8.

Change From Baseline in Glucagon (Week 12).

The change between the value of glucagon collected at week 12 and glucagon collected at baseline. (NCT00286455)
Timeframe: Baseline and Week 12.

Change From Baseline in Glucagon (Week 16).

The change between the value of glucagon collected at week 16 and glucagon collected at baseline. (NCT00286455)
Timeframe: Baseline and Week 16.

Change From Baseline in Glucagon (Week 20).

The change between the value of glucagon collected at week 20 and glucagon collected at baseline. (NCT00286455)
Timeframe: Baseline and Week 20.

Change From Baseline in Glucagon (Week 26).

The change between the value of glucagon collected at week 26 or final visit and glucagon collected at baseline. (NCT00286455)
Timeframe: Baseline and Week 26.

Change From Baseline in Glucagon (Week 4).

The change between the value of glucagon collected at week 4 and glucagon collected at baseline. (NCT00286455)
Timeframe: Baseline and Week 4.

Change From Baseline in Glucagon (Week 8).

The change between the value of glucagon collected at week 8 and glucagon collected at baseline. (NCT00286455)
Timeframe: Baseline and Week 8.

Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26.

The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 26 or final visit and glycosylated hemoglobin collected at baseline. (NCT00286455)
Timeframe: Baseline and Week 26.

Change From Baseline in Glycosylated Hemoglobin (Week 12).

The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 12 and Glycosylated Hemoglobin collected at baseline. (NCT00286455)
Timeframe: Baseline and Week 12.

Change From Baseline in Glycosylated Hemoglobin (Week 16).

The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 16 and Glycosylated Hemoglobin collected at baseline. (NCT00286455)
Timeframe: Baseline and Week 16.

Change From Baseline in Glycosylated Hemoglobin (Week 20).

The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 20 and Glycosylated Hemoglobin collected at baseline. (NCT00286455)
Timeframe: Baseline and Week 20.

Change From Baseline in Glycosylated Hemoglobin (Week 4).

The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 4 and Glycosylated Hemoglobin collected at baseline. (NCT00286455)
Timeframe: Baseline and Week 4.

Change From Baseline in Glycosylated Hemoglobin (Week 8).

The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 8 and Glycosylated Hemoglobin collected at baseline. (NCT00286455)
Timeframe: Baseline and Week 8.

Change From Baseline in Insulin (Week 12).

The change between the value of insulin collected at week 12 and insulin collected at baseline. (NCT00286455)
Timeframe: Baseline and Week 12.

Change From Baseline in Insulin (Week 16).

The change between the value of insulin collected at week 16 and insulin collected at baseline. (NCT00286455)
Timeframe: Baseline and Week 16.

Change From Baseline in Insulin (Week 20).

The change between the value of insulin collected at week 20 and insulin collected at baseline. (NCT00286455)
Timeframe: Baseline and Week 20.

Change From Baseline in Insulin (Week 26).

The change between the value of insulin collected at week 26 and insulin collected at baseline. (NCT00286455)
Timeframe: Baseline and Week 26.

Change From Baseline in Insulin (Week 4).

The change between the value of insulin collected at week 4 and insulin collected at baseline. (NCT00286455)
Timeframe: Baseline and Week 4.

Change From Baseline in Insulin (Week 8).

The change between the value of insulin collected at week 8 and insulin collected at baseline. (NCT00286455)
Timeframe: Baseline and Week 8.

Change From Baseline in Proinsulin/Insulin Ratio (Week 12).

The change between the ratio value of proinsulin and insulin collected at week 12 and the ratio value of proinsulin and insulin collected at baseline. (NCT00286455)
Timeframe: Baseline and Week 12.

Change From Baseline in Proinsulin/Insulin Ratio (Week 16).

The change between the ratio value of proinsulin and insulin collected at week 16 and the ratio value of proinsulin and insulin collected at baseline. (NCT00286455)
Timeframe: Baseline and Week 16.

Change From Baseline in Proinsulin/Insulin Ratio (Week 20).

The change between the ratio value of proinsulin and insulin collected at week 20 and the ratio value of proinsulin and insulin collected at baseline. (NCT00286455)
Timeframe: Baseline and Week 20.

Change From Baseline in Proinsulin/Insulin Ratio (Week 26).

The change between the ratio value of proinsulin and insulin collected at week 26 or final visit and the ratio value of proinsulin and insulin collected at baseline. (NCT00286455)
Timeframe: Baseline and Week 26.

Change From Baseline in Proinsulin/Insulin Ratio (Week 4).

The change between the ratio value of proinsulin and insulin collected at week 4 and the ratio value of proinsulin and insulin collected at baseline. (NCT00286455)
Timeframe: Baseline and Week 4.

Change From Baseline in Proinsulin/Insulin Ratio (Week 8).

The change between the ratio value of proinsulin and insulin collected at week 8 and the ratio value of proinsulin and insulin collected at baseline. (NCT00286455)
Timeframe: Baseline and Week 8.

Number of Participants Requiring Rescue.

The number of participants requiring rescue for failing to achieve pre-specified glycemic targets during the 26 week study. (NCT00286455)
Timeframe: 26 Weeks.

Number of Participants With Glycosylated Hemoglobin ≤ 6.5%.

The number of participants with a value for the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) less than or equal to 6.5% during the 26 week study. (NCT00286455)
Timeframe: Baseline and Week 26.

Number of Participants With Glycosylated Hemoglobin ≤ 7.0%.

The number of participants with a value for the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) less than or equal to 7.0% during the 26 week study. (NCT00286455)
Timeframe: Baseline and Week 26.

Number of Participants With Glycosylated Hemoglobin ≤ 7.5%.

The number of participants with a value for the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) less than or equal to 7.5% during the 26 week study. (NCT00286455)
Timeframe: Baseline and Week 26.

Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 0.5%.

The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 0.5% during the 26 week study. (NCT00286455)
Timeframe: Baseline and Week 26.

Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 1.0%.

The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 1.0% during the 26 week study. (NCT00286455)
Timeframe: Baseline and Week 26.

Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 1.5%.

The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 1.5% during the 26 week study. (NCT00286455)
Timeframe: Baseline and Week 26.

Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 2.0%.

The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 2.0% during the 26 week study. (NCT00286455)
Timeframe: Baseline and Week 26.

Number of Participants With Marked Hyperglycemia (Fasting Plasma Glucose ≥ 200 mg Per dL).

The number of participants with a fasting plasma glucose value greater than or equal to 200 mg per dL at any measurement time point during the 26 week study. (NCT00286455)
Timeframe: 26 Weeks.

Change From Baseline in Body Weight (Week 12).

The change between Body Weight measured at week 12 and Body Weight measured at baseline. (NCT00286468)
Timeframe: Baseline and Week 12.

Change From Baseline in Body Weight (Week 20).

The change between Body Weight measured at week 20 and Body Weight measured at baseline. (NCT00286468)
Timeframe: Baseline and Week 20.

Change From Baseline in Body Weight (Week 26).

The change between Body Weight measured at week 26 or final visit and Body Weight measured at baseline. (NCT00286468)
Timeframe: Baseline and Week 26.

Change From Baseline in Body Weight (Week 8).

The change between Body Weight measured at week 8 and Body Weight measured at baseline. (NCT00286468)
Timeframe: Baseline and Week 8.

Change From Baseline in C-peptide (Week 12).

The change between the value of C-peptide collected at week 12 and C-peptide collected at baseline. (NCT00286468)
Timeframe: Baseline and Week 12.

Change From Baseline in C-peptide (Week 16).

The change between the value of C-peptide collected at week 16 and C-peptide collected at baseline. (NCT00286468)
Timeframe: Baseline and Week 16.

Change From Baseline in C-peptide (Week 20).

The change between the value of C-peptide collected at week 20 and C-peptide collected at baseline. (NCT00286468)
Timeframe: Baseline and Week 20.

Change From Baseline in C-peptide (Week 26).

The change between the value of C-peptide collected at week 26 or final visit and C-peptide collected at baseline. (NCT00286468)
Timeframe: Baseline and Week 26.

Change From Baseline in C-peptide (Week 4).

The change between the value of C-peptide collected at week 4 and C-peptide collected at baseline. (NCT00286468)
Timeframe: Baseline and Week 4.

Change From Baseline in C-peptide (Week 8).

The change between the value of C-peptide collected at week 8 and C-peptide collected at baseline. (NCT00286468)
Timeframe: Baseline and Week 8.

Change From Baseline in Fasting Plasma Glucose (Week 1).

The change between the value of fasting plasma glucose collected at final visit or week 1 and fasting plasma glucose collected at baseline. (NCT00286468)
Timeframe: Baseline and Week 1.

Change From Baseline in Fasting Plasma Glucose (Week 12).

The change between the value of fasting plasma glucose collected at week 12 and fasting plasma glucose collected at baseline. (NCT00286468)
Timeframe: Baseline and Week 12.

Change From Baseline in Fasting Plasma Glucose (Week 16).

The change between the value of fasting plasma glucose collected at week 16 and fasting plasma glucose collected at baseline. (NCT00286468)
Timeframe: Baseline and Week 16.

Change From Baseline in Fasting Plasma Glucose (Week 2).

The change between the value of fasting plasma glucose collected at week 2 and fasting plasma glucose collected at baseline. (NCT00286468)
Timeframe: Baseline and Week 2.

Change From Baseline in Fasting Plasma Glucose (Week 20).

The change between the value of fasting plasma glucose collected at week 20 and fasting plasma glucose collected at baseline. (NCT00286468)
Timeframe: Baseline and Week 20.

Change From Baseline in Fasting Plasma Glucose (Week 26).

The change between the value of fasting plasma glucose collected at week 26 or final visit and fasting plasma glucose collected at baseline. (NCT00286468)
Timeframe: Baseline and Week 26.

Change From Baseline in Fasting Plasma Glucose (Week 4).

The change between the value of fasting plasma glucose collected at week 4 and fasting plasma glucose collected at baseline. (NCT00286468)
Timeframe: Baseline and Week 4.

Change From Baseline in Fasting Plasma Glucose (Week 8).

The change between the value of fasting plasma glucose collected at week 8 and fasting plasma glucose collected at baseline. (NCT00286468)
Timeframe: Baseline and Week 8.

Change From Baseline in Fasting Proinsulin (Week 12).

The change between the value of fasting proinsulin collected at week 12 and fasting proinsulin collected at baseline. (NCT00286468)
Timeframe: Baseline and Week 12.

Change From Baseline in Fasting Proinsulin (Week 16).

The change between the value of fasting proinsulin collected at week 16 and fasting proinsulin collected at baseline. (NCT00286468)
Timeframe: Baseline and Week 16.

Change From Baseline in Fasting Proinsulin (Week 20).

The change between the value of fasting proinsulin collected at week 20 and fasting proinsulin collected at baseline. (NCT00286468)
Timeframe: Baseline and Week 20.

Change From Baseline in Fasting Proinsulin (Week 26).

The change between the value of fasting proinsulin collected at week 26 or final visit and fasting proinsulin collected at baseline. (NCT00286468)
Timeframe: Baseline and Week 26.

Change From Baseline in Fasting Proinsulin (Week 4).

The change between the value of fasting proinsulin collected at week 4 and fasting proinsulin collected at baseline. (NCT00286468)
Timeframe: Baseline and Week 4.

Change From Baseline in Fasting Proinsulin (Week 8).

The change between the value of fasting proinsulin collected at week 8 and fasting proinsulin collected at baseline. (NCT00286468)
Timeframe: Baseline and Week 8.

Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26.

Change From Baseline in Glycosylated Hemoglobin (Week 12).

Change From Baseline in Glycosylated Hemoglobin (Week 16).

Change From Baseline in Glycosylated Hemoglobin (Week 20).

Change From Baseline in Glycosylated Hemoglobin (Week 4).

Change From Baseline in Glycosylated Hemoglobin (Week 8).

Change From Baseline in Insulin (Week 12).

The change between the value of insulin collected at week 12 and insulin collected at baseline. (NCT00286468)
Timeframe: Baseline and Week 12.

Change From Baseline in Insulin (Week 16).

The change between the value of insulin collected at week 16 and insulin collected at baseline. (NCT00286468)
Timeframe: Baseline and Week 16.

Change From Baseline in Insulin (Week 20).

The change between the value of insulin collected at week 20 and insulin collected at baseline. (NCT00286468)
Timeframe: Baseline and Week 20.

Change From Baseline in Insulin (Week 26).

The change between the value of insulin collected at week 26 and insulin collected at baseline. (NCT00286468)
Timeframe: Baseline and Week 26.

Change From Baseline in Insulin (Week 4).

The change between the value of insulin collected at week 4 and insulin collected at baseline. (NCT00286468)
Timeframe: Baseline and Week 4.

Change From Baseline in Insulin (Week 8).

The change between the value of insulin collected at week 8 and insulin collected at baseline. (NCT00286468)
Timeframe: Baseline and Week 8.

Change From Baseline in Proinsulin/Insulin Ratio (Week 12).

The change between the ratio value of proinsulin and insulin collected at week 12 and the ratio value of proinsulin and insulin collected at baseline. (NCT00286468)
Timeframe: Baseline and Week 12.

Change From Baseline in Proinsulin/Insulin Ratio (Week 16).

The change between the ratio value of proinsulin and insulin collected at week 16 and the ratio value of proinsulin and insulin collected at baseline. (NCT00286468)
Timeframe: Baseline and Week 16.

Change From Baseline in Proinsulin/Insulin Ratio (Week 20).

The change between the ratio value of proinsulin and insulin collected at week 20 and the ratio value of proinsulin and insulin collected at baseline. (NCT00286468)
Timeframe: Baseline and Week 20.

Change From Baseline in Proinsulin/Insulin Ratio (Week 26).

The change between the ratio value of proinsulin and insulin collected at week 26 or final visit and the ratio value of proinsulin and insulin collected at baseline. (NCT00286468)
Timeframe: Baseline and Week 26.

Change From Baseline in Proinsulin/Insulin Ratio (Week 4).

The change between the ratio value of proinsulin and insulin collected at week 4 and the ratio value of proinsulin and insulin collected at baseline. (NCT00286468)
Timeframe: Baseline and Week 4.

Change From Baseline in Proinsulin/Insulin Ratio (Week 8).

The change between the ratio value of proinsulin and insulin collected at week 8 and the ratio value of proinsulin and insulin collected at baseline. (NCT00286468)
Timeframe: Baseline and Week 8.

Number of Participants Requiring Rescue.

The number of participants requiring rescue for failing to achieve pre-specified glycemic targets during the 26 week study. (NCT00286468)
Timeframe: 26 Weeks.

Number of Participants With Glycosylated Hemoglobin ≤ 6.5%.

Number of Participants With Glycosylated Hemoglobin ≤ 7.0%.

Number of Participants With Glycosylated Hemoglobin ≤ 7.5%.

Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 0.5%.

Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 1.0%.

The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 1.0% during the 26 week study. (NCT00286468)
Timeframe: Baseline and Week 26.

Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 1.5%.

The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 1.5% during the 26 week study. (NCT00286468)
Timeframe: Baseline and Week 26.

Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 2.0%.

The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 2.0% during the 26 week study. (NCT00286468)
Timeframe: Baseline and Week 26.

Number of Participants With Marked Hyperglycemia (Fasting Plasma Glucose ≥ 200 mg Per dL).

The number of participants with a fasting plasma glucose value greater than or equal to 200 mg per dL during the 26 week study. (NCT00286468)
Timeframe: 26 Weeks.

Change From Baseline in Body Weight (Week 12).

The change between Body Weight measured at week 12 and Body Weight measured at baseline. (NCT00286442)
Timeframe: Baseline and Week 12.

Change From Baseline in Body Weight (Week 20).

The change between Body Weight measured at week 20 and Body Weight measured at baseline. (NCT00286442)
Timeframe: Baseline and Week 20.

Change From Baseline in Body Weight (Week 26).

The change between Body Weight measured at week 26 or final visit and Body Weight measured at baseline. (NCT00286442)
Timeframe: Baseline and Week 26.

Change From Baseline in Body Weight (Week 8).

The change between Body Weight measured at week 8 and Body Weight measured at baseline. (NCT00286442)
Timeframe: Baseline and Week 8.

Change From Baseline in C-peptide (Week 12).

The change between the value of C-peptide collected at week 12 and C-peptide collected at baseline. (NCT00286442)
Timeframe: Baseline and Week 12.

Change From Baseline in C-peptide (Week 16).

The change between the value of C-peptide collected at week 16 and C-peptide collected at baseline. (NCT00286442)
Timeframe: Baseline and Week 16.

Change From Baseline in C-peptide (Week 20).

The change between the value of C-peptide collected at week 20 and C-peptide collected at baseline. (NCT00286442)
Timeframe: Baseline and Week 20.

Change From Baseline in C-peptide (Week 26).

The change between the value of C-peptide collected at week 26 or final visit and C-peptide collected at baseline. (NCT00286442)
Timeframe: Baseline and Week 26.

Change From Baseline in C-peptide (Week 4).

The change between the value of C-peptide collected at week 4 and C-peptide collected at baseline. (NCT00286442)
Timeframe: Baseline and Week 4.

Change From Baseline in C-peptide (Week 8).

The change between the value of C-peptide collected at week 8 and C-peptide collected at baseline. (NCT00286442)
Timeframe: Baseline and Week 8.

Change From Baseline in Fasting Plasma Glucose (Week 1).

The change between the value of fasting plasma glucose collected at final visit or week 1 and fasting plasma glucose collected at baseline. (NCT00286442)
Timeframe: Baseline and Week 1.

Change From Baseline in Fasting Plasma Glucose (Week 12).

The change between the value of fasting plasma glucose collected at week 12 and fasting plasma glucose collected at baseline. (NCT00286442)
Timeframe: Baseline and Week 12.

Change From Baseline in Fasting Plasma Glucose (Week 16).

The change between the value of fasting plasma glucose collected at week 16 and fasting plasma glucose collected at baseline. (NCT00286442)
Timeframe: Baseline and Week 16.

Change From Baseline in Fasting Plasma Glucose (Week 2).

The change between the value of fasting plasma glucose collected at week 2 and fasting plasma glucose collected at baseline. (NCT00286442)
Timeframe: Baseline and Week 2.

Change From Baseline in Fasting Plasma Glucose (Week 20).

The change between the value of fasting plasma glucose collected at week 20 and fasting plasma glucose collected at baseline. (NCT00286442)
Timeframe: Baseline and Week 20.

Change From Baseline in Fasting Plasma Glucose (Week 26).

The change between the value of fasting plasma glucose collected at week 26 or final visit and fasting plasma glucose collected at baseline. (NCT00286442)
Timeframe: Baseline and Week 26.

Change From Baseline in Fasting Plasma Glucose (Week 4).

The change between the value of fasting plasma glucose collected at week 4 and fasting plasma glucose collected at baseline. (NCT00286442)
Timeframe: Baseline and Week 4.

Change From Baseline in Fasting Plasma Glucose (Week 8).

The change between the value of fasting plasma glucose collected at week 8 and fasting plasma glucose collected at baseline. (NCT00286442)
Timeframe: Baseline and Week 8.

Change From Baseline in Fasting Proinsulin (Week 12).

The change between the value of fasting proinsulin collected at week 12 and fasting proinsulin collected at baseline. (NCT00286442)
Timeframe: Baseline and Week 12.

Change From Baseline in Fasting Proinsulin (Week 16).

The change between the value of fasting proinsulin collected at week 16 and fasting proinsulin collected at baseline. (NCT00286442)
Timeframe: Baseline and Week 16.

Change From Baseline in Fasting Proinsulin (Week 20).

The change between the value of fasting proinsulin collected at week 20 and fasting proinsulin collected at baseline. (NCT00286442)
Timeframe: Baseline and Week 20.

Change From Baseline in Fasting Proinsulin (Week 26).

The change between the value of fasting proinsulin collected at week 26 or final visit and fasting proinsulin collected at baseline. (NCT00286442)
Timeframe: Baseline and Week 26.

Change From Baseline in Fasting Proinsulin (Week 4).

The change between the value of fasting proinsulin collected at week 4 and fasting proinsulin collected at baseline. (NCT00286442)
Timeframe: Baseline and Week 4.

Change From Baseline in Fasting Proinsulin (Week 8).

The change between the value of fasting proinsulin collected at week 8 and fasting proinsulin collected at baseline. (NCT00286442)
Timeframe: Baseline and Week 8.

Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26.

Change From Baseline in Glycosylated Hemoglobin (Week 12).

Change From Baseline in Glycosylated Hemoglobin (Week 16).

Change From Baseline in Glycosylated Hemoglobin (Week 20).

Change From Baseline in Glycosylated Hemoglobin (Week 4).

Change From Baseline in Glycosylated Hemoglobin (Week 8).

Change From Baseline in Insulin (Week 12).

The change between the value of insulin collected at week 12 and insulin collected at baseline. (NCT00286442)
Timeframe: Baseline and Week 12.

Change From Baseline in Insulin (Week 16).

The change between the value of insulin collected at week 16 and insulin collected at baseline. (NCT00286442)
Timeframe: Baseline and Week 16.

Change From Baseline in Insulin (Week 20).

The change between the value of insulin collected at week 20 and insulin collected at baseline. (NCT00286442)
Timeframe: Baseline and Week 20.

Change From Baseline in Insulin (Week 26).

The change between the value of insulin collected at week 26 and insulin collected at baseline. (NCT00286442)
Timeframe: Baseline and Week 26.

Change From Baseline in Insulin (Week 4).

The change between the value of insulin collected at week 4 and insulin collected at baseline. (NCT00286442)
Timeframe: Baseline and Week 4.

Change From Baseline in Insulin (Week 8).

The change between the value of insulin collected at week 8 and insulin collected at baseline. (NCT00286442)
Timeframe: Baseline and Week 8.

Change From Baseline in Proinsulin/Insulin Ratio (Week 12).

The change between the ratio value of proinsulin and insulin collected at week 12 and the ratio value of proinsulin and insulin collected at baseline. (NCT00286442)
Timeframe: Baseline and Week 12.

Change From Baseline in Proinsulin/Insulin Ratio (Week 16).

The change between the ratio value of proinsulin and insulin collected at week 16 and the ratio value of proinsulin and insulin collected at baseline. (NCT00286442)
Timeframe: Baseline and Week 16.

Change From Baseline in Proinsulin/Insulin Ratio (Week 20).

The change between the ratio value of proinsulin and insulin collected at week 20 and the ratio value of proinsulin and insulin collected at baseline. (NCT00286442)
Timeframe: Baseline and Week 20.

Change From Baseline in Proinsulin/Insulin Ratio (Week 26).

The change between the ratio value of proinsulin and insulin collected at week 26 or final visit and the ratio value of proinsulin and insulin collected at baseline. (NCT00286442)
Timeframe: Baseline and Week 26.

Change From Baseline in Proinsulin/Insulin Ratio (Week 4).

The change between the ratio value of proinsulin and insulin collected at week 4 and the ratio value of proinsulin and insulin collected at baseline. (NCT00286442)
Timeframe: Baseline and Week 4.

Change From Baseline in Proinsulin/Insulin Ratio (Week 8).

The change between the ratio value of proinsulin and insulin collected at week 8 and the ratio value of proinsulin and insulin collected at baseline. (NCT00286442)
Timeframe: Baseline and Week 8.

Number of Participants Requiring Rescue.

The number of participants requiring rescue for failing to achieve pre-specified glycemic targets during the 26 week study. (NCT00286442)
Timeframe: 26 Weeks.

Number of Participants With Glycosylated Hemoglobin ≤ 6.5%.

Number of Participants With Glycosylated Hemoglobin ≤ 7.0%.

Number of Participants With Glycosylated Hemoglobin ≤ 7.5%.

Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 0.5%.

Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 1.0%.

The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 1.0% during the 26 week study. (NCT00286442)
Timeframe: Baseline and Week 26.

Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 1.5%.

The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 1.5% during the 26 week study. (NCT00286442)
Timeframe: Baseline and Week 26.

Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 2.0%.

The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 2.0% during the 26 week study. (NCT00286442)
Timeframe: Baseline and Week 26.

Number of Participants With Marked Hyperglycemia (Fasting Plasma Glucose ≥ 200 mg Per dL).

The number of participants with a fasting plasma glucose value greater than or equal to 200 mg per dL during the 26 week study. (NCT00286442)
Timeframe: 26 Weeks.

Change From Baseline in Body Weight (Week 12).

The change between Body Weight measured at week 12 and Body Weight measured at baseline. (NCT00286494)
Timeframe: Baseline and Week 12.

Change From Baseline in Body Weight (Week 20).

The change between Body Weight measured at week 20 and Body Weight measured at baseline. (NCT00286494)
Timeframe: Baseline and Week 20.

Change From Baseline in Body Weight (Week 26).

The change between Body Weight measured at week 26 or final visit and Body Weight measured at baseline. (NCT00286494)
Timeframe: Baseline and Week 26.

Change From Baseline in Body Weight (Week 8).

The change between Body Weight measured at week 8 and Body Weight measured at baseline. (NCT00286494)
Timeframe: Baseline and Week 8.

Change From Baseline in C-peptide (Week 12).

The change between the value of C-peptide collected at week 12 and C-peptide collected at baseline. (NCT00286494)
Timeframe: Baseline and Week 12.

Change From Baseline in C-peptide (Week 16).

The change between the value of C-peptide collected at week 16 and C-peptide collected at baseline. (NCT00286494)
Timeframe: Baseline and Week 16.

Change From Baseline in C-peptide (Week 20).

The change between the value of C-peptide collected at week 20 and C-peptide collected at baseline. (NCT00286494)
Timeframe: Baseline and Week 20.

Change From Baseline in C-peptide (Week 26).

The change between the value of C-peptide collected at week 26 or final visit and C-peptide collected at baseline. (NCT00286494)
Timeframe: Baseline and Week 26.

Change From Baseline in C-peptide (Week 4).

The change between the value of C-peptide collected at week 4 and C-peptide collected at baseline. (NCT00286494)
Timeframe: Baseline and Week 4.

Change From Baseline in C-peptide (Week 8).

The change between the value of C-peptide collected at week 8 and C-peptide collected at baseline. (NCT00286494)
Timeframe: Baseline and Week 8.

Change From Baseline in Fasting Plasma Glucose (Week 1).

The change between the value of fasting plasma glucose collected at final visit or week 1 and fasting plasma glucose collected at baseline. (NCT00286494)
Timeframe: Baseline and Week 1.

Change From Baseline in Fasting Plasma Glucose (Week 12).

The change between the value of fasting plasma glucose collected at week 12 and fasting plasma glucose collected at baseline. (NCT00286494)
Timeframe: Baseline and Week 12.

Change From Baseline in Fasting Plasma Glucose (Week 16).

The change between the value of fasting plasma glucose collected at week 16 and fasting plasma glucose collected at baseline. (NCT00286494)
Timeframe: Baseline and Week 16.

Change From Baseline in Fasting Plasma Glucose (Week 2).

The change between the value of fasting plasma glucose collected at week 2 and fasting plasma glucose collected at baseline. (NCT00286494)
Timeframe: Baseline and Week 2.

Change From Baseline in Fasting Plasma Glucose (Week 20).

The change between the value of fasting plasma glucose collected at week 20 and fasting plasma glucose collected at baseline. (NCT00286494)
Timeframe: Baseline and Week 20.

Change From Baseline in Fasting Plasma Glucose (Week 26).

The change between the value of fasting plasma glucose collected at week 26 or final visit and fasting plasma glucose collected at baseline. (NCT00286494)
Timeframe: Baseline and Week 26.

Change From Baseline in Fasting Plasma Glucose (Week 4).

The change between the value of fasting plasma glucose collected at week 4 and fasting plasma glucose collected at baseline. (NCT00286494)
Timeframe: Baseline and Week 4.

Change From Baseline in Fasting Plasma Glucose (Week 8).

The change between the value of fasting plasma glucose collected at week 8 and fasting plasma glucose collected at baseline. (NCT00286494)
Timeframe: Baseline and Week 8.

Change From Baseline in Fasting Proinsulin (Week 12).

The change between the value of fasting proinsulin collected at week 12 and fasting proinsulin collected at baseline. (NCT00286494)
Timeframe: Baseline and Week 12.

Change From Baseline in Fasting Proinsulin (Week 16).

The change between the value of fasting proinsulin collected at week 16 and fasting proinsulin collected at baseline. (NCT00286494)
Timeframe: Baseline and Week 16.

Change From Baseline in Fasting Proinsulin (Week 20).

The change between the value of fasting proinsulin collected at week 20 and fasting proinsulin collected at baseline. (NCT00286494)
Timeframe: Baseline and Week 20.

Change From Baseline in Fasting Proinsulin (Week 26).

The change between the value of fasting proinsulin collected at week 26 or final visit and fasting proinsulin collected at baseline. (NCT00286494)
Timeframe: Baseline and Week 26.

Change From Baseline in Fasting Proinsulin (Week 4).

The change between the value of fasting proinsulin collected at week 4 and fasting proinsulin collected at baseline. (NCT00286494)
Timeframe: Baseline and Week 4.

Change From Baseline in Fasting Proinsulin (Week 8).

The change between the value of fasting proinsulin collected at week 8 and fasting proinsulin collected at baseline. (NCT00286494)
Timeframe: Baseline and Week 8.

Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26.

Change From Baseline in Glycosylated Hemoglobin (Week 12).

Change From Baseline in Glycosylated Hemoglobin (Week 16).

Change From Baseline in Glycosylated Hemoglobin (Week 20).

Change From Baseline in Glycosylated Hemoglobin (Week 4).

Change From Baseline in Glycosylated Hemoglobin (Week 8).

Change From Baseline in Insulin (Week 12).

The change between the value of insulin collected at week 12 and insulin collected at baseline. (NCT00286494)
Timeframe: Baseline and Week 12.

Change From Baseline in Insulin (Week 16).

The change between the value of insulin collected at week 16 and insulin collected at baseline. (NCT00286494)
Timeframe: Baseline and Week 16.

Change From Baseline in Insulin (Week 20).

The change between the value of insulin collected at week 20 and insulin collected at baseline. (NCT00286494)
Timeframe: Baseline and Week 20.

Change From Baseline in Insulin (Week 26).

The change between the value of insulin collected at week 26 and insulin collected at baseline. (NCT00286494)
Timeframe: Baseline and Week 26.

Change From Baseline in Insulin (Week 4).

The change between the value of insulin collected at week 4 and insulin collected at baseline. (NCT00286494)
Timeframe: Baseline and Week 4.

Change From Baseline in Insulin (Week 8).

The change between the value of insulin collected at week 8 and insulin collected at baseline. (NCT00286494)
Timeframe: Baseline and Week 8.

Change From Baseline in Proinsulin/Insulin Ratio (Week 12).

The change between the ratio value of proinsulin and insulin collected at week 12 and the ratio value of proinsulin and insulin collected at baseline. (NCT00286494)
Timeframe: Baseline and Week 12.

Change From Baseline in Proinsulin/Insulin Ratio (Week 16).

The change between the ratio value of proinsulin and insulin collected at week 16 and the ratio value of proinsulin and insulin collected at baseline. (NCT00286494)
Timeframe: Baseline and Week 16.

Change From Baseline in Proinsulin/Insulin Ratio (Week 20).

The change between the ratio value of proinsulin and insulin collected at week 20 and the ratio value of proinsulin and insulin collected at baseline. (NCT00286494)
Timeframe: Baseline and Week 20.

Change From Baseline in Proinsulin/Insulin Ratio (Week 26).

The change between the ratio value of proinsulin and insulin collected at week 26 or final visit and the ratio value of proinsulin and insulin collected at baseline. (NCT00286494)
Timeframe: Baseline and Week 26.

Change From Baseline in Proinsulin/Insulin Ratio (Week 4).

The change between the ratio value of proinsulin and insulin collected at week 4 and the ratio value of proinsulin and insulin collected at baseline. (NCT00286494)
Timeframe: Baseline and Week 4.

Change From Baseline in Proinsulin/Insulin Ratio (Week 8).

The change between the ratio value of proinsulin and insulin collected at week 8 and the ratio value of proinsulin and insulin collected at baseline. (NCT00286494)
Timeframe: Baseline and Week 8.

Number of Participants Requiring Rescue.

The number of participants requiring rescue for failing to achieve pre-specified glycemic targets during the 26 week study. (NCT00286494)
Timeframe: 26 Weeks.

Number of Participants With Glycosylated Hemoglobin ≤ 6.5%.

Number of Participants With Glycosylated Hemoglobin ≤ 7.0%.

The number of participants with a value for the percentage of glycosylated hemoglobin less (the percentage of hemoglobin that is bound to glucose) than or equal to 7.0% during the 26 week study. (NCT00286494)
Timeframe: Baseline and Week 26.

Number of Participants With Glycosylated Hemoglobin ≤ 7.5%.

Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 0.5%.

Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 1.0%.

The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 1.0% during the 26 week study. (NCT00286494)
Timeframe: Baseline and Week 26.

Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 1.5%.

The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 1.5% during the 26 week study. (NCT00286494)
Timeframe: Baseline and Week 26.

Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 2.0%.

The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 2.0% during the 26 week study. (NCT00286494)
Timeframe: Baseline and Week 26.

Number of Participants With Marked Hyperglycemia (Fasting Plasma Glucose ≥ 200 mg Per dL).

The number of participants with a fasting plasma glucose value greater than or equal to 200 mg per dL during the 26 week study. (NCT00286494)
Timeframe: 26 Weeks.

Change From Baseline in Body Weight (Week 12).

The change between Body Weight measured at week 12 and Body Weight measured at baseline. (NCT00286429)
Timeframe: Baseline and Week 12.

Change From Baseline in Body Weight (Week 20).

The change between Body Weight measured at week 20 and Body Weight measured at baseline. (NCT00286429)
Timeframe: Baseline and Week 20.

Change From Baseline in Body Weight (Week 26).

The change between Body Weight measured at week 26 or final visit and Body Weight measured at baseline. (NCT00286429)
Timeframe: Baseline and Week 26.

Change From Baseline in Body Weight (Week 8).

The change between Body Weight measured at week 8 and Body Weight measured at baseline. (NCT00286429)
Timeframe: Baseline and Week 8.

Change From Baseline in C-peptide (Week 12).

The change between the value of C-peptide collected at week 12 and C-peptide collected at baseline. (NCT00286429)
Timeframe: Baseline and Week 12.

Change From Baseline in C-peptide (Week 16).

The change between the value of C-peptide collected at week 16 and C-peptide collected at baseline. (NCT00286429)
Timeframe: Baseline and Week 16.

Change From Baseline in C-peptide (Week 20).

The change between the value of C-peptide collected at week 20 and C-peptide collected at baseline. (NCT00286429)
Timeframe: Baseline and Week 20.

Change From Baseline in C-peptide (Week 26).

The change between the value of C-peptide collected at week 26 or final visit and C-peptide collected at baseline. (NCT00286429)
Timeframe: Baseline and Week 26.

Change From Baseline in C-peptide (Week 4).

The change between the value of C-peptide collected at week 4 and C-peptide collected at baseline. (NCT00286429)
Timeframe: Baseline and Week 4.

Change From Baseline in C-peptide (Week 8).

The change between the value of C-peptide collected at week 8 and C-peptide collected at baseline. (NCT00286429)
Timeframe: Baseline and Week 8.

Change From Baseline in Fasting Plasma Glucose (Week 1).

The change between the value of fasting plasma glucose collected at final visit or week 1 and fasting plasma glucose collected at baseline. (NCT00286429)
Timeframe: Baseline and Week 1.

Change From Baseline in Fasting Plasma Glucose (Week 12).

The change between the value of fasting plasma glucose collected at week 12 and fasting plasma glucose collected at baseline. (NCT00286429)
Timeframe: Baseline and Week 12.

Change From Baseline in Fasting Plasma Glucose (Week 16).

The change between the value of fasting plasma glucose collected at week 16 and fasting plasma glucose collected at baseline. (NCT00286429)
Timeframe: Baseline and Week 16.

Change From Baseline in Fasting Plasma Glucose (Week 2).

The change between the value of fasting plasma glucose collected at week 2 and fasting plasma glucose collected at baseline. (NCT00286429)
Timeframe: Baseline and Week 2.

Change From Baseline in Fasting Plasma Glucose (Week 20).

The change between the value of fasting plasma glucose collected at week 20 and fasting plasma glucose collected at baseline. (NCT00286429)
Timeframe: Baseline and Week 20.

Change From Baseline in Fasting Plasma Glucose (Week 26).

The change between the value of fasting plasma glucose collected at week 26 or final visit and fasting plasma glucose collected at baseline. (NCT00286429)
Timeframe: Baseline and Week 26.

Change From Baseline in Fasting Plasma Glucose (Week 4).

The change between the value of fasting plasma glucose collected at week 4 and fasting plasma glucose collected at baseline. (NCT00286429)
Timeframe: Baseline and Week 4.

Change From Baseline in Fasting Plasma Glucose (Week 8).

The change between the value of fasting plasma glucose collected at week 8 and fasting plasma glucose collected at baseline. (NCT00286429)
Timeframe: Baseline and Week 8.

Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26.

Change From Baseline in Glycosylated Hemoglobin (Week 12).

Change From Baseline in Glycosylated Hemoglobin (Week 16).

Change From Baseline in Glycosylated Hemoglobin (Week 20).

Change From Baseline in Glycosylated Hemoglobin (Week 4).

Change From Baseline in Glycosylated Hemoglobin (Week 8).

Number of Participants Requiring Rescue.

The number of participants requiring rescue for failing to achieve pre-specified glycemic targets during the 26 week study. (NCT00286429)
Timeframe: 26 Weeks.

Number of Participants With Glycosylated Hemoglobin ≤ 6.5%.

Number of Participants With Glycosylated Hemoglobin ≤ 7.0%.

Number of Participants With Glycosylated Hemoglobin ≤ 7.5%.

Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 0.5%.

Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 1.0%.

The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 1.0% during the 26 week study. (NCT00286429)
Timeframe: Baseline and Week 26.

Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 1.5%.

The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 1.5% during the 26 week study. (NCT00286429)
Timeframe: Baseline and Week 26.

Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 2.0%.

The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 2.0% during the 26 week study. (NCT00286429)
Timeframe: Baseline and Week 26.

Number of Participants With Marked Hyperglycemia (Fasting Plasma Glucose ≥ 200 mg Per dL).

The number of participants with a fasting plasma glucose value greater than or equal to 200 mg per dL during the 26 week study. (NCT00286429)
Timeframe: 26 Weeks.

Change From Baseline in Fasting Fructosamine (Day 43).

The change between the value of fasting fructosamine collected at day 43 and fasting fructosamine collected at baseline. (NCT00755846)
Timeframe: Baseline and Day 43.

Change From Baseline in Fasting Fructosamine (Day 85).

The change between the value of fasting fructosamine collected at day 85 or final visit and fasting fructosamine collected at baseline. (NCT00755846)
Timeframe: Baseline and Day 85.

Change From Baseline in Fasting Plasma Glucose (Day 43).

The change between the value of fasting plasma glucose collected at day 43 and fasting plasma glucose collected at baseline. (NCT00755846)
Timeframe: Baseline and Day 43

Change From Baseline in Fasting Plasma Glucose (Day 85).

The change between the value of fasting plasma glucose collected at day 85 or final visit and fasting plasma glucose collected at baseline. (NCT00755846)
Timeframe: Baseline and Day 85.

Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Day 85.

The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at day 85 or final visit and glycosylated hemoglobin collected at baseline. (NCT00755846)
Timeframe: Baseline and Day 85.

Change From Baseline in Glycosylated Hemoglobin at Day 43.

The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at day 43 and glycosylated hemoglobin collected at baseline. (NCT00755846)
Timeframe: Baseline and Day 43.

Change From Baseline in High-Density Lipoprotein Cholesterol (Day 43).

The change between high-density lipoprotein cholesterol collected at day 43 and high-density lipoprotein cholesterol collected at baseline. (NCT00755846)
Timeframe: Baseline and Day 43.

Change From Baseline in High-Density Lipoprotein Cholesterol (Day 85).

The change between high-density lipoprotein cholesterol collected at day 85 or final visit and high-density lipoprotein cholesterol collected at baseline. (NCT00755846)
Timeframe: Baseline and Day 85.

Change From Baseline in Low-Density Lipoprotein Cholesterol (Day 43).

The change between low-density lipoprotein cholesterol collected at day 43 and low-density lipoprotein cholesterol collected at baseline. (NCT00755846)
Timeframe: Baseline and Day 43.

Change From Baseline in Low-Density Lipoprotein Cholesterol (Day 85).

The change between low-density lipoprotein cholesterol collected at day 85 or final visit and low-density lipoprotein cholesterol collected at baseline. (NCT00755846)
Timeframe: Baseline and Day 85.

Change From Baseline in Total Cholesterol (Day 43).

The change between the value of cholesterol collected at day 43 and cholesterol collected at baseline. (NCT00755846)
Timeframe: Baseline and Day 43

Change From Baseline in Total Cholesterol (Day 85).

The change between the value of cholesterol collected at day 85 or final visit and cholesterol collected at baseline. (NCT00755846)
Timeframe: Baseline and Day 85.

Change From Baseline in Triglycerides (Day 43).

The change between triglycerides collected at day 43 and triglycerides collected at baseline. (NCT00755846)
Timeframe: Baseline and Day 43.

Change From Baseline in Triglycerides (Day 85).

The change between triglycerides collected at day 85 or final visit and triglycerides collected at baseline. (NCT00755846)
Timeframe: Baseline and Day 85.

Mean Percent Incidence of Marked Hyperglycemia (Fasting Plasma Glucose ≥ 200 mg/dL).

The incidence of marked hyperglycemia occurring in participants with a fasting plasma glucose value greater than or equal to 200 mg per dL during study. Overall mean obtained by weighting the hyperglycemia percent incidence values at each time point by number of days in between visits. Mean percent incidence of marked hyperglycemia at each time point is the percent of self-monitored blood glucose measurements greater than or equal to 200 mg per dL, calculated per participant and then averaged across population. (NCT00755846)
Timeframe: 85 Days.

Change From Baseline to Week 26 in Glycosylated Hemoglobin (HbA1c)

The change from Baseline to Week 26 in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound). (NCT00395512)
Timeframe: Baseline and Week 26

Percentage of Participants With a Decrease in Glycosylated Hemoglobin Greater Than or Equal to 0.5%

Clinical response at Week 26 was assessed by the percentage of participants with a decrease from Baseline in HbA1c of ≥ 0.5%. (NCT00395512)
Timeframe: Baseline and Week 26

Percentage of Participants With a Decrease in Glycosylated Hemoglobin Greater Than or Equal to 1.0%

Clinical response at Week 26 was assessed by the percentage of participants with a decrease from Baseline in HbA1c of ≥ 1%. (NCT00395512)
Timeframe: Baseline and Week 26

Percentage of Participants With a Decrease in Glycosylated Hemoglobin Greater Than or Equal to 1.5%.

Clinical response at Week 26 was assessed by the percentage of participants with a decrease from Baseline in HbA1c of ≥ 1.5%. (NCT00395512)
Timeframe: Baseline and Week 26

Percentage of Participants With a Decrease in Glycosylated Hemoglobin Greater Than or Equal to 2.0%

Clinical response at Week 26 was assessed by the percentage of participants with a decrease from Baseline in HbA1c of ≥ 2.0%. (NCT00395512)
Timeframe: Baseline and Week 26

Percentage of Participants With Glycosylated Hemoglobin Less Than or Equal to 6.5%

Clinical response at Week 26 was assessed by the percentage of participants with HbA1c ≤6.5%. (NCT00395512)
Timeframe: Week 26

Percentage of Participants With Glycosylated Hemoglobin Less Than or Equal to 7.0%

Clinical response at Week 26 was assessed by the percentage of participants with HbA1c ≤ 7%. (NCT00395512)
Timeframe: Week 26

Percentage of Participants With Glycosylated Hemoglobin Less Than or Equal to 7.5%

Clinical response at Week 26 was assessed by the percentage of participants with HbA1c ≤ 7.5%. (NCT00395512)
Timeframe: Week 26

Change From Baseline in Adiponectin

Change from Baseline in adiponectin was assessed at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline adiponectin as a covariate. (NCT00395512)
Timeframe: Baseline and Weeks 12 and 26.

Change From Baseline in Apolipoprotein A1

Change from Baseline in Apolipoprotein A1 was assessed at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and Baseline apolipoprotein A1 as a covariate. (NCT00395512)
Timeframe: Baseline and Weeks 12 and 26.

Change From Baseline in Apolipoprotein A2

Change from Baseline in apolipoprotein A2 was assessed at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline apolipoprotein A2 as a covariate. (NCT00395512)
Timeframe: Baseline and Weeks 12 and 26.

Change From Baseline in Apolipoprotein B

Change from Baseline in apolipoprotein B was assessed at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline apolipoprotein B as a covariate. (NCT00395512)
Timeframe: Baseline and Weeks 12 and 26.

Change From Baseline in Apolipoprotein C-III

Change from Baseline in apolipoprotein C-III was assessed at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline apolipoprotein C-III as a covariate. (NCT00395512)
Timeframe: Baseline and Weeks 12 and 26.

Change From Baseline in Body Weight

Change from Baseline in body weight was assessed at Weeks 8, 12, 20 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and Baseline weight as a covariate. (NCT00395512)
Timeframe: Baseline and Weeks 8, 12, 20 and 26.

Change From Baseline in C-peptide Levels

C-peptide is a byproduct created when the hormone insulin is produced and is measured by a blood test. Change from Baseline was assessed at Weeks 4, 8, 12, 16, 20 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline C-peptide as a covariate. (NCT00395512)
Timeframe: Baseline and Weeks 4, 8, 12, 16, 20 and 26.

Change From Baseline in Calculated Homeostatic Model Assessment Insulin Resistance

"The Homeostasis Model Assessment of insulin resistance (HOMA IR) measures insulin resistance based on fasting glucose and insulin measurements:~HOMA IR = fasting plasma insulin (µIU/mL) * fasting plasma glucose (mmol/L) / 22.5~A higher number indicates a greater degree of insulin resistance. The change from Baseline in HOMA IR was assessed at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline HOMA IR as a covariate." (NCT00395512)
Timeframe: Baseline and Weeks 12 and 26.

Change From Baseline in Fasting Plasma Glucose Over Time

The change from Baseline in fasting plasma glucose was assessed at weeks 1, 2, 4, 8, 12, 16, 20 and 26. Least Squares Means were from an ANCOVA model with treatment and geographic region as class variables and baseline plasma glucose as a covariate. (NCT00395512)
Timeframe: Baseline and Weeks 1, 2, 4, 8, 12, 16, 20 and 26.

Change From Baseline in Fasting Proinsulin

Proinsulin is a precursor to insulin, and was measured as an indicator of pancreatic function. The change from Baseline in fasting proinsulin was assessed at Weeks 4, 8, 12, 16, 20 and 26. Least Squares Means were from an ANCOVA model with treatment and geographic region as class variables and baseline proinsulin as a covariate. (NCT00395512)
Timeframe: Baseline and Weeks 4, 8, 12, 16, 20 and 26.

Change From Baseline in Free Fatty Acids

Change from Baseline in free fatty acids (FFA) was assessed at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline free fatty acid as a covariate. (NCT00395512)
Timeframe: Baseline and Weeks 12 and 26.

Change From Baseline in HbA1c Over Time

The change from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) at 4 week intervals during the study. Least Squares Means were from an Analysis of Covariance (ANCOVA) model with treatment and geographic region as class variables and baseline HbA1c as a covariate. (NCT00395512)
Timeframe: Baseline and Weeks 4, 8, 12, 16 and 20.

Change From Baseline in High Density Lipoprotein (HDL) Particles

"The change from Baseline in levels of total, large, medium and small HDL particles was assessed by NMR fractionation at Weeks 12 and 26.~Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline HDL particles as a covariate." (NCT00395512)
Timeframe: Baseline and Weeks 12 and 26.

Change From Baseline in High-Density Lipoprotein Cholesterol

Change from Baseline in high-density lipoprotein cholesterol (HDL-C) was assessed at Weeks 4, 8, 12, 16, 20 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline HDL cholesterol as a covariate. (NCT00395512)
Timeframe: Baseline and Weeks 4, 8, 12, 16, 20 and 26.

Change From Baseline in High-sensitivity C-Reactive Protein

Change from Baseline in high-sensitivity C-Reactive Protein (hsCRP) was assessed at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline hsCRP as a covariate. (NCT00395512)
Timeframe: Baseline and Weeks 12 and 26.

Change From Baseline in Homeostatic Model Assessment Beta Cell Function

"The Homeostasis Model Assessment (HOMA) estimates steady state beta cell function (%B) as a percentage of a normal reference population.~HOMA %B = 20 * insulin (µIU/mL) / fasting plasma glucose (mmol/L) - 3.5~The change from Baseline in the homeostasis model assessment of beta cell function was assessed at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline HOMA beta cell function as a covariate." (NCT00395512)
Timeframe: Baseline and Weeks 12 and 26.

Change From Baseline in Insulin

The change from Baseline in fasting insulin was assessed at Weeks 4, 8, 12, 16, 20 and 26. Least Squares Means were from an ANCOVA model with treatment and geographic region as class variables and baseline insulin as a covariate. (NCT00395512)
Timeframe: Baseline and Weeks 4, 8, 12, 16, 20 and 26.

Change From Baseline in Intermediate Density Lipoprotein (IDL) Particles

"The change from Baseline in levels of IDL particles was assessed by NMR fractionation at Weeks 12 and 26.~Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline IDL particles as a covariate." (NCT00395512)
Timeframe: Baseline and Weeks 12 and 26.

Change From Baseline in Low Density Lipoprotein (LDL) Particles

"The change from Baseline in levels of total, large, medium-small, total small and very small LDL particles was assessed by NMR fractionation at Weeks 12 and 26.~Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline LDL particles as a covariate." (NCT00395512)
Timeframe: Baseline and Weeks 12 and 26.

Change From Baseline in Low-Density Lipoprotein Cholesterol

Change from Baseline in low-density lipoprotein cholesterol (LDL-C) was assessed at Weeks 4, 8, 12, 16, 20 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline LDL cholesterol as a covariate. (NCT00395512)
Timeframe: Baseline and Weeks 4, 8, 12, 16, 20 and 26.

Change From Baseline in Mean HDL Particle Size

Change from Baseline in mean HDL particle size was assessed by NMR lipid fractionation at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline mean HDL particle size as a covariate. (NCT00395512)
Timeframe: Baseline and Weeks 12 and 26.

Change From Baseline in Mean LDL Particle Size

Change from Baseline in mean LDL particle size was assessed by NMR lipid fractionation at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline mean LDL particle size as a covariate. (NCT00395512)
Timeframe: Baseline and Weeks 12 and 26.

Change From Baseline in Mean VLDL Particle Size

Change from Baseline in mean VLDL particle size was assessed by NMR lipid fractionation at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline mean VLDL particle size as a covariate. (NCT00395512)
Timeframe: Baseline and Weeks 12 and 26.

Change From Baseline in Nuclear Magnetic Resonance Lipid Fractionation Total Triglycerides

Nuclear Magnetic Resonance (NMR) lipid fractionation was used to assess the change from Baseline in total triglyceride levels at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline NMR total triglycerides as a covariate. (NCT00395512)
Timeframe: Baseline and Weeks 12 and 26.

Change From Baseline in Plasminogen Activator Inhibitor-1

Change from Baseline in plasminogen activator inhibitor-1 was assessed at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline plasminogen activator inhibitor-1 as a covariate. (NCT00395512)
Timeframe: Baseline and Weeks 12 and 26.

Change From Baseline in Proinsulin/Insulin Ratio

The ratio of proinsulin to insulin was calculated as proinsulin (pmol/L) / insulin (μIU/mL) at weeks 4, 8, 12, 16, 20 and 26 relative to the Baseline value. Least squares means were from an ANCOVA model with treatment and geographic region as class variables and Baseline proinsulin/insulin ratio as a covariate. (NCT00395512)
Timeframe: Baseline and Weeks 4, 8, 12, 16, 20 and 26.

Change From Baseline in Total Cholesterol Level

Change from Baseline in total cholesterol level was assessed at Weeks 4, 8, 12, 16, 20 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline total cholesterol as a covariate. (NCT00395512)
Timeframe: Baseline and Weeks 4, 8, 12, 16, 20 and 26.

Change From Baseline in Triglyceride Levels

Change from Baseline in triglycerides was assessed at Weeks 4, 8, 12, 16, 20 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline triglycerides as a covariate. (NCT00395512)
Timeframe: Baseline and Weeks 4, 8, 12, 16, 20 and 26.

Change From Baseline in Very Low Density Lipoprotein (VLDL) / Chylomicron Particles

"The change from Baseline in levels of total VLDL/chylomicron particles and large VLDL/chylomicron particles was assessed by NMR lipid fractionation at Weeks 12 and 26.~Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline VLDL/chylomicron particles as a covariate." (NCT00395512)
Timeframe: Baseline and Weeks 12 and 26.

Change From Baseline in VLDL / Chylomicron Triglycerides

"The change from Baseline in levels of VLDL/chylomicron triglycerides was assessed by NMR lipid fractionation at Weeks 12 and 26.~Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline VLDL/chylomicron triglycerides as a covariate." (NCT00395512)
Timeframe: Baseline and Weeks 12 and 26.

Change From Baseline in VLDL Particles

"The change from Baseline in levels of medium VLDL particles and small VLDL particles was assessed by NMR fractionation at Weeks 12 and 26.~Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline VLDL particles as a covariate." (NCT00395512)
Timeframe: Baseline and Weeks 12 and 26.

Percentage of Participants Meeting Rescue Criteria

"Rescue was defined as meeting 1 of the following criteria, confirmed by a 2nd sample drawn within 5 days after the first sample and analyzed by the central laboratory:~After more than 4 weeks of treatment but prior to the Week 8 Visit: a single fasting plasma glucose ≥310 mg/dL (≥17.5 mmol/L);~From the Week 8 Visit but prior to the Week 12 Visit: a single fasting plasma glucose ≥275 mg/dL (≥15.27 mmol/L);~From the Week 12 Visit through the End-of-Treatment Visit: HbA1c ≥8.5% and ≤0.5% reduction in HbA1c as compared with the Baseline HbA1c." (NCT00395512)
Timeframe: Weeks 4, 8, 12, 16, 20 and 26.

Percentage of Participants With Marked Hyperglycemia

Marked Hyperglycemia is defined as fasting plasma glucose greater than or equal to 200 mg/dL. Study week windows are defined to place hyperglycemia into visit categories. (NCT00395512)
Timeframe: Weeks 1, 2, 4, 8, 12, 16, 20 and 26.

Percentage of Participants Meeting Hyperglycemic Rescue Criteria

"Rescue was defined as meeting 1 of the following criteria, confirmed by a 2nd sample drawn within 7 days after the first sample and analyzed by the central laboratory:~After more than 2 weeks of treatment but prior to the Week 4 Visit: A single fasting plasma glucose (FPG) ≥275 mg/dL;~From the Week 4 Visit but prior to the Week 8 Visit: A single FPG ≥250 mg/dL;~From the Week 8 Visit but prior to the Week 12 Visit: A single FPG ≥225 mg/dL;~From the Week 12 Visit through the End-of-Treatment Visit: HbA1c ≥8.5% AND ≤0.5% reduction in HbA1c as compared with the baseline HbA1c." (NCT00432276)
Timeframe: Baseline to Week 52

Percentage of Participants With Marked Hyperglycemia

Marked Hyperglycemia is defined as fasting plasma glucose greater than or equal to 200 mg/dL (11.10 mmol/L). (NCT00432276)
Timeframe: Baseline to Week 52

Change From Baseline in Adiponectin

Change from Baseline in adiponectin was assessed at Weeks 12, 26, 42 and 52. Least squares means are from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline adiponectin as covariates. (NCT00432276)
Timeframe: Baseline and Weeks 12, 26, 42 and 52.

Change From Baseline in Apolipoprotein A1

Change from Baseline in Apolipoprotein A1 was assessed at Weeks 12, 26, 42 and 52. Least squares means are from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein A1 as covariates. (NCT00432276)
Timeframe: Baseline and Weeks 12, 26, 42 and 52.

Change From Baseline in Apolipoprotein A2

Change from Baseline in Apolipoprotein A2 was assessed at Weeks 12, 26, 42 and 52. Least squares means are from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein A2 as covariates. (NCT00432276)
Timeframe: Baseline and Weeks 12, 26, 42 and 52.

Change From Baseline in Apolipoprotein B

Change from Baseline in Apolipoprotein B was assessed at Weeks 12, 26, 42 and 52. Least squares means are from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein B as covariates. (NCT00432276)
Timeframe: Baseline and Weeks 12, 26, 42 and 52.

Change From Baseline in Apolipoprotein C-III

Change from Baseline in Apolipoprotein C-III was assessed at Weeks 12, 26, 42 and 52. Least squares means are from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein C-III as covariates. (NCT00432276)
Timeframe: Baseline and Weeks 12, 26, 42 and 52.

Change From Baseline in Body Weight

Change from Baseline in body weight was assessed at Weeks 4, 8, 12, 26, 42 and 52. Least squares means are from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline body weight as covariates. (NCT00432276)
Timeframe: Baseline and Weeks 4, 8, 12, 26, 42 and 52.

Change From Baseline in C-peptide

C-peptide is a byproduct created when the hormone insulin is produced and is measured by a blood test. Change from Baseline was assessed at Weeks 4, 8, 12, 16, 20, 26, 34, 42 and 52. Least squares means are from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline fasting C-peptide as covariates. (NCT00432276)
Timeframe: Baseline and Weeks 4, 8, 12, 16, 20, 26, 34, 42 and 52.

Change From Baseline in Calculated HOMA Beta-cell Function

"The Homeostasis Model Assessment (HOMA) estimates steady state beta cell function (%B) as a percentage of a normal reference population.~HOMA %B = 20 * insulin (µIU/mL) / fasting plasma glucose (mmol/L) - 3.5~The change from Baseline in the homeostasis model assessment of beta cell function was assessed at Weeks 12, 26, 42 and 52. Least squares means are from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline HOMA beta cell function as covariates." (NCT00432276)
Timeframe: Baseline and Weeks 12, 26, 42 and 52.

Change From Baseline in Calculated HOMA Insulin Resistance

"The Homeostasis Model Assessment of insulin resistance (HOMA IR) measures insulin resistance based on fasting glucose and insulin measurements:~HOMA IR = fasting plasma insulin (µIU/mL) * fasting plasma glucose (mmol/L) / 22.5~A higher number indicates a greater degree of insulin resistance. The change from Baseline in HOMA IR was assessed at Weeks 12, 26, 42 and 52. Least squares means are from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline HOMA insulin resistance as covariates." (NCT00432276)
Timeframe: Baseline and Weeks 12, 26, 42 and 52.

Change From Baseline in Fasting Insulin

The change from Baseline in fasting insulin was assessed at Weeks 4, 8, 12, 16, 20, 26, 34, 42 and 52. Least Squares Means were from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline fasting insulin as covariates. (NCT00432276)
Timeframe: Baseline and Weeks 4, 8, 12, 16, 20, 26, 34, 42 and 52.

Change From Baseline in Fasting Plasma Glucose

The change from Baseline in fasting plasma glucose (FPG) was assessed at Weeks 2, 4, 8, 12, 16, 20, 26, 34, 42 and 52. Least Squares Means were from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline FPG as covariates. (NCT00432276)
Timeframe: Baseline and Weeks 2, 4, 8, 12, 16, 20, 26, 34, 42 and 52.

Change From Baseline in Fasting Proinsulin

Proinsulin is a precursor to insulin, and was measured as an indicator of pancreatic function. The change from Baseline in fasting proinsulin was assessed at Weeks 4, 8, 12, 16, 20, 26, 34, 42 and 52. Least Squares Means were from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline fasting proinsulin as covariates. (NCT00432276)
Timeframe: Baseline and Weeks 4, 8, 12, 16, 20, 26, 34, 42 and 52.

Change From Baseline in Free Fatty Acids

Change from Baseline in free fatty acids was assessed at Weeks 12, 26, 42 and 52. Least squares means are from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline free fatty acids as covariates. (NCT00432276)
Timeframe: Baseline and Weeks 12, 26, 42, and 52.

Change From Baseline in Glycosylated Hemoglobin (HbA1c)

The change from Baseline to Week 26 and Week 52 in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound). (NCT00432276)
Timeframe: Baseline and Weeks 26 and 52.

Change From Baseline in HbA1c Over Time

The change from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) during the study. Least Squares Means were from an Analysis of Covariance (ANCOVA) model with treatment, study schedule, and geographic region as class variables, and baseline metformin dose and baseline HbA1c as covariates. (NCT00432276)
Timeframe: Baseline and Weeks 4, 8, 12, 16, 20, 34 and 42.

Change From Baseline in High Density Lipoprotein (HDL) Particles

The change from Baseline in levels of total, large, medium and small HDL particles was assessed by NMR fractionation at Weeks 12, 26, 42 and 52. Least squares means are from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline HDL particles as covariates. (NCT00432276)
Timeframe: Baseline and Weeks 12, 26, 42 and 52.

Change From Baseline in High-Density Lipoprotein Cholesterol

Change from Baseline in high-density lipoprotein cholesterol (HDL-C) was assessed at Weeks 4, 8, 12, 16, 20, 26, 34, 42 and 52. Least squares means are from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline HDL cholesterol as covariates. (NCT00432276)
Timeframe: Baseline and Weeks 4, 8, 12, 16, 20, 26, 34, 42 and 52.

Change From Baseline in High-sensitivity C-Reactive Protein

Change from Baseline in high-sensitivity C-Reactive Protein (hsCRP) was assessed at Weeks 12, 26, 42 and 52. Least squares means are from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline hsCRP as covariates. (NCT00432276)
Timeframe: Baseline and Weeks 12, 26, 42 and 52.

Change From Baseline in Intermediate Density Lipoprotein (IDL) Particles

The change from Baseline in levels of IDL particles was assessed by NMR lipid fractionation at Weeks 12, 26, 42 and 52. Least squares means are from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline IDL particles as covariates. (NCT00432276)
Timeframe: Baseline and Weeks 12, 26, 42 and 52.

Change From Baseline in Low Density Lipoprotein (LDL) Particles

The change from Baseline in levels of total, large, medium-small, total small and very small LDL particles was assessed by NMR fractionation at Weeks 12, 26, 42 and 52. Least squares means are from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline LDL particles as covariates. (NCT00432276)
Timeframe: Baseline and Weeks 12, 26, 42 and 52.

Change From Baseline in Low-Density Lipoprotein Cholesterol

Change from Baseline in low-density lipoprotein cholesterol (LDL-C) was assessed at Weeks 4, 8, 12, 16, 20, 26, 34, 42 and 52. Least squares means are from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline LDL cholesterol as covariates. (NCT00432276)
Timeframe: Baseline and Weeks 4, 8, 12, 16, 20, 26, 34, 42 and 52.

Change From Baseline in Mean HDL Particle Size

Change from Baseline in mean HDL particle size was assessed by NMR lipid fractionation at Weeks 12, 26, 42 and 52. Least squares means are from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline mean HDL particle size as covariates. (NCT00432276)
Timeframe: Baseline and Weeks 12, 26, 42 and 52.

Change From Baseline in Mean LDL Particle Size

Change from Baseline in mean LDL particle size was assessed by NMR lipid fractionation at Weeks 12, 26, 42 and 52. Least squares means are from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline mean LDL particle size as covariates. (NCT00432276)
Timeframe: Baseline and Weeks 12, 26, 42 and 52.

Change From Baseline in Mean VLDL Particle Size

Change from Baseline in mean VLDL particle size was assessed by NMR lipid fractionation at Weeks 12, 26, 42 and 52. Least squares means are from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline mean VLDL particle size as covariates. (NCT00432276)
Timeframe: Baseline and Weeks 12, 26, 42 and 52.

Change From Baseline in Nuclear Magnetic Resonance Lipid Fractionation Total Triglycerides

Nuclear Magnetic Resonance (NMR) lipid fractionation was used to assess the change from Baseline in total triglyceride levels at Weeks 12, 26, 42 and 52. Least squares means are from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline NMR triglycerides as covariates. (NCT00432276)
Timeframe: Baseline and Weeks 12, 26, 42 and 52.

Change From Baseline in Plasminogen Activator Inhibitor-1

Change from Baseline in plasminogen activator inhibitor-1 (PAI-1) was assessed at Weeks 12, 26, 42 and 52. Least squares means are from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline PAI-1 as covariates. (NCT00432276)
Timeframe: Baseline and Weeks 12, 26, 42 and 52.

Change From Baseline in Proinsulin/Insulin Ratio

The ratio of proinsulin to insulin was calculated as proinsulin (pmol/L) / insulin (μIU/mL) at weeks 4, 8, 12, 16, 20, 26, 34, 42 and 52 relative to the Baseline value. Least squares means were from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline fasting proinsulin/insulin ratio as covariates. (NCT00432276)
Timeframe: Baseline and Weeks 4, 8, 12, 16, 20, 26, 34, 42 and 52.

Change From Baseline in Total Cholesterol

Change from Baseline in total cholesterol was assessed at Weeks 4, 8, 12, 16, 20, 26, 34, 42 and 52. Least squares means are from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline total cholesterol as covariates. (NCT00432276)
Timeframe: Baseline and Weeks 4, 8, 12, 16, 20, 26, 34, 42 and 52.

Change From Baseline in Triglycerides

Change from Baseline in triglycerides was assessed at Weeks 4, 8, 12, 16, 20, 26, 34, 42 and 52. Least squares means are from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline triglycerides as covariates. (NCT00432276)
Timeframe: Baseline and Weeks 4, 8, 12, 16, 20, 26, 34, 42 and 52.

Change From Baseline in Very Low Density Lipoprotein (VLDL) / Chylomicron Particles

"The change from Baseline in levels of total VLDL/chylomicron particles and large VLDL/chylomicron particles was assessed by NMR lipid fractionation at Weeks 12, 26, 42 and 52.~Least squares means are from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline VLDL/chylomicron particles as covariates." (NCT00432276)
Timeframe: Baseline and Weeks 12, 26, 42 and 52.

Change From Baseline in VLDL / Chylomicron Triglycerides

"The change from Baseline in levels of VLDL/chylomicron triglycerides was assessed by NMR lipid fractionation at Weeks 12, 26, 42 and 52.~Least squares means are from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline VLDL/chylomicron triglycerides as covariates." (NCT00432276)
Timeframe: Baseline and Weeks 12, 26, 42 and 52.

Change From Baseline in VLDL Particles

The change from Baseline in levels of medium VLDL particles and small VLDL particles was assessed by NMR fractionation at Weeks 12, 26, 42 and 52. Least squares means are from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline VLDL particles as covariates. (NCT00432276)
Timeframe: Baseline and Weeks 12, 26, 42 and 52.

Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥ 0.5%

Clinical response at Weeks 26 and 52 was assessed by the percentage of participants with a decrease from Baseline in HbA1c of greater than or equal to 0.5%. (NCT00432276)
Timeframe: Weeks 26 and 52.

Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥ 1.0%

Clinical response at Weeks 26 and 52 was assessed by the percentage of participants with a decrease from Baseline in HbA1c of greater than or equal to 1.0%. (NCT00432276)
Timeframe: Weeks 26 and 52.

Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥ 1.5%

Clinical response at Weeks 26 and 52 was assessed by the percentage of participants with a decrease from Baseline in HbA1c of greater than or equal to 1.5%. (NCT00432276)
Timeframe: Weeks 26 and 52.

Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥ 2.0%

Clinical response at Weeks 26 and 52 was assessed by the percentage of participants with a decrease from Baseline in HbA1c of greater than or equal to 2.0%. (NCT00432276)
Timeframe: Weeks 26 and 52.

Percentage of Participants With Glycosylated Hemoglobin ≤ 6.5%

Clinical response at Weeks 26 and 52 was assessed by the percentage of participants with HbA1c less than or equal to 6.5%. (NCT00432276)
Timeframe: Weeks 26 and 52.

Percentage of Participants With Glycosylated Hemoglobin ≤ 7.0%

Clinical response at Weeks 26 and 52 was assessed by the percentage of participants with HbA1c less than or equal to 7%. (NCT00432276)
Timeframe: Weeks 26 and 52.

Percentage of Participants With Glycosylated Hemoglobin ≤ 7.5%

Clinical response at Weeks 26 and 52 was assessed by the percentage of participants with HbA1c less than or equal to 7.5%. (NCT00432276)
Timeframe: Weeks 26 and 52.

Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value).

The change between the value of blood glucose collected at week 12 or final visit and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and at 2 hours after the start of the meal. (NCT01263483)
Timeframe: Baseline and Week 12.

Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)).

Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2).

The change between the value of C-peptide collected at week 12 or final visit and C-peptide collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and at 2 hours after the start of the meal. (NCT01263483)
Timeframe: Baseline and Week 12.

Change From Baseline in Fasting C-peptide (Week 12).

The change between the value of fasting C-peptide collected at week 12 or final visit and fasting C-peptide collected at baseline. (NCT01263483)
Timeframe: Baseline and Week 12.

Change From Baseline in Fasting C-peptide (Week 2).

The change between the value of fasting C-peptide collected at week 2 and fasting C-peptide collected at baseline. (NCT01263483)
Timeframe: Baseline and Week 2.

Change From Baseline in Fasting C-peptide (Week 4).

The change between the value of fasting C-peptide collected at week 4 and fasting C-peptide collected at baseline. (NCT01263483)
Timeframe: Baseline and Week 4.

Change From Baseline in Fasting C-peptide (Week 8).

The change between the value of fasting C-peptide collected at week 8 and fasting C-peptide collected at baseline. (NCT01263483)
Timeframe: Baseline and Week 8.

Change From Baseline in Fasting Plasma Glucose (Week 12).

The change between the value of fasting plasma glucose collected at week 12 or final visit and fasting plasma glucose collected at baseline. (NCT01263483)
Timeframe: Baseline and Week 12.

Change From Baseline in Fasting Plasma Glucose (Week 2).

The change between the value of fasting plasma glucose collected at week 2 and fasting plasma glucose collected at baseline. (NCT01263483)
Timeframe: Baseline and Week 2

Change From Baseline in Fasting Plasma Glucose (Week 4).

The change between the value of fasting plasma glucose collected at week 4 and fasting plasma glucose collected at baseline. (NCT01263483)
Timeframe: Baseline and Week 4.

Change From Baseline in Fasting Plasma Glucose (Week 8).

The change between the value of fasting plasma glucose collected at week 8 and fasting plasma glucose collected at baseline. (NCT01263483)
Timeframe: Baseline and Week 8.

Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)).

The change between the value of glucagons collected at week 12 or final visit and glucagons collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and at 2 hours after the start of the meal. (NCT01263483)
Timeframe: Baseline and Week 12

Change From Baseline in Glycosylated Hemoglobin (Week 12).

The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 12 or final visit and glycosylated hemoglobin collected at baseline. (NCT01263483)
Timeframe: Baseline and Week 12.

Change From Baseline in Glycosylated Hemoglobin (Week 2).

The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 2 and glycosylated hemoglobin collected at baseline. (NCT01263483)
Timeframe: Baseline and Week 2.

Change From Baseline in Glycosylated Hemoglobin (Week 4).

The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 4 and glycosylated hemoglobin collected at baseline. (NCT01263483)
Timeframe: Baseline and Week 4.

Change From Baseline in Glycosylated Hemoglobin (Week 8).

The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 8 and glycosylated hemoglobin collected at baseline. (NCT01263483)
Timeframe: Baseline and Week 8.

Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2).

The change between the value of insulin collected at week 12 or final visit and insulin collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and at 2 hours after the start of the meal. (NCT01263483)
Timeframe: Baseline and Week 12

Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value) (Final Visit).

The change between the value of blood glucose collected at week 52 or final visit and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal. (NCT01263509)
Timeframe: Baseline and Final Visit (up to Week 52).

Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value) (Week 12).

The change between the value of blood glucose collected at week 12 and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal. (NCT01263509)
Timeframe: Baseline and Week 12.

Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value) (Week 24).

The change between the value of blood glucose collected at week 24 and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal. (NCT01263509)
Timeframe: Baseline and Week 24.

Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value) (Week 52).

The change between the value of blood glucose collected at week 52 and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal. (NCT01263509)
Timeframe: Baseline and Week 52.

Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)) (Final Visit).

Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)) (Week 12).

Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)) (Week 24).

Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)) (Week 52).

Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2)) (Final Visit).

The change between the value of C-peptide collected at week 52 or final visit and C-peptide collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal. (NCT01263509)
Timeframe: Baseline and Final Visit (up to Week 52).

Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2)) (Week 12).

The change between the value of C-peptide collected at week 12 and C-peptide collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal. (NCT01263509)
Timeframe: Baseline and Week 12.

Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2)) (Week 24).

The change between the value of C-peptide collected at week 24 and C-peptide collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal. (NCT01263509)
Timeframe: Baseline and Week 24.

Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2)) (Week 52).

The change between the value of C-peptide collected at week 52 and C-peptide collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal. (NCT01263509)
Timeframe: Baseline and Week 52.

Change From Baseline in Fasting C-peptide (Final Visit).

The change between the value of fasting C-peptide collected at week 52 or final visit and fasting C-peptide collected at baseline. (NCT01263509)
Timeframe: Baseline and Final Visit (up to Week 52).

Change From Baseline in Fasting C-peptide (Week 12).

The change between the value of fasting C-peptide collected at week 12 and fasting C-peptide collected at baseline. (NCT01263509)
Timeframe: Baseline and Week 12.

Change From Baseline in Fasting C-peptide (Week 16).

The change between the value of fasting C-peptide collected at week 16 and fasting C-peptide collected at baseline. (NCT01263509)
Timeframe: Baseline and Week 16.

Change From Baseline in Fasting C-peptide (Week 20).

The change between the value of fasting C-peptide collected at week 20 and fasting C-peptide collected at baseline. (NCT01263509)
Timeframe: Baseline and Week 20.

Change From Baseline in Fasting C-peptide (Week 24).

The change between the value of fasting C-peptide collected at week 24 and fasting C-peptide collected at baseline. (NCT01263509)
Timeframe: Baseline and Week 24.

Change From Baseline in Fasting C-peptide (Week 28).

The change between the value of fasting C-peptide collected at week 28 and fasting C-peptide collected at baseline. (NCT01263509)
Timeframe: Baseline and Week 28.

Change From Baseline in Fasting C-peptide (Week 32).

The change between the value of fasting C-peptide collected at week 32 and fasting C-peptide collected at baseline. (NCT01263509)
Timeframe: Baseline and Week 32.

Change From Baseline in Fasting C-peptide (Week 36).

The change between the value of fasting C-peptide collected at week 36 and fasting C-peptide collected at baseline. (NCT01263509)
Timeframe: Baseline and Week 36.

Change From Baseline in Fasting C-peptide (Week 40).

The change between the value of fasting C-peptide collected at week 40 and fasting C-peptide collected at baseline. (NCT01263509)
Timeframe: Baseline and Week 40.

Change From Baseline in Fasting C-peptide (Week 44).

The change between the value of fasting C-peptide collected at week 44 and fasting C-peptide collected at baseline. (NCT01263509)
Timeframe: Baseline and Week 44.

Change From Baseline in Fasting C-peptide (Week 48).

The change between the value of fasting C-peptide collected at week 48 and fasting C-peptide collected at baseline. (NCT01263509)
Timeframe: Baseline and Week 48.

Change From Baseline in Fasting C-peptide (Week 52).

The change between the value of fasting C-peptide collected at week 52 and fasting C-peptide collected at baseline. (NCT01263509)
Timeframe: Baseline and Week 52.

Change From Baseline in Fasting C-peptide (Week 8).

The change between the value of fasting C-peptide collected at week 8 and fasting C-peptide collected at baseline. (NCT01263509)
Timeframe: Baseline and Week 8.

Change From Baseline in Fasting Plasma Glucose (Final Visit).

The change between the value of fasting plasma glucose collected at week 52 or final visit and fasting plasma glucose collected at baseline. (NCT01263509)
Timeframe: Baseline and Final Visit (up to Week 52).

Change From Baseline in Fasting Plasma Glucose (Week 12).

The change between the value of fasting plasma glucose collected at week 12 and fasting plasma glucose collected at baseline. (NCT01263509)
Timeframe: Baseline and Week 12.

Change From Baseline in Fasting Plasma Glucose (Week 16).

The change between the value of fasting plasma glucose collected at week 16 and fasting plasma glucose collected at baseline. (NCT01263509)
Timeframe: Baseline and Week 16.

Change From Baseline in Fasting Plasma Glucose (Week 20).

The change between the value of fasting plasma glucose collected at week 20 and fasting plasma glucose collected at baseline. (NCT01263509)
Timeframe: Baseline and Week 20.

Change From Baseline in Fasting Plasma Glucose (Week 24).

The change between the value of fasting plasma glucose collected at week 24 and fasting plasma glucose collected at baseline. (NCT01263509)
Timeframe: Baseline and Week 24.

Change From Baseline in Fasting Plasma Glucose (Week 28).

The change between the value of fasting plasma glucose collected at week 28 and fasting plasma glucose collected at baseline. (NCT01263509)
Timeframe: Baseline and Week 28.

Change From Baseline in Fasting Plasma Glucose (Week 32).

The change between the value of fasting plasma glucose collected at week 32 and fasting plasma glucose collected at baseline. (NCT01263509)
Timeframe: Baseline and Week 32.

Change From Baseline in Fasting Plasma Glucose (Week 36).

The change between the value of fasting plasma glucose collected at week 36 and fasting plasma glucose collected at baseline. (NCT01263509)
Timeframe: Baseline and Week 36.

Change From Baseline in Fasting Plasma Glucose (Week 40).

The change between the value of fasting plasma glucose collected at week 40 and fasting plasma glucose collected at baseline. (NCT01263509)
Timeframe: Baseline and Week 40.

Change From Baseline in Fasting Plasma Glucose (Week 44).

The change between the value of fasting plasma glucose collected at week 44 and fasting plasma glucose collected at baseline. (NCT01263509)
Timeframe: Baseline and Week 44.

Change From Baseline in Fasting Plasma Glucose (Week 48).

The change between the value of fasting plasma glucose collected at week 48 and fasting plasma glucose collected at baseline. (NCT01263509)
Timeframe: Baseline and Week 48.

Change From Baseline in Fasting Plasma Glucose (Week 52).

The change between the value of fasting plasma glucose collected at week 52 and fasting plasma glucose collected at baseline. (NCT01263509)
Timeframe: Baseline and Week 52.

Change From Baseline in Fasting Plasma Glucose (Week 8).

The change between the value of fasting plasma glucose collected at week 8 and fasting plasma glucose collected at baseline. (NCT01263509)
Timeframe: Baseline and Week 8.

Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)) (Final Visit).

The change between the value of glucagons collected at week 52 or final visit and glucagons collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal. (NCT01263509)
Timeframe: Baseline and Final Visit (up to Week 52).

Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)) (Week 12).

The change between the value of glucagons collected at week 12 and glucagons collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal. (NCT01263509)
Timeframe: Baseline and Week 12.

Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)) (Week 24).

The change between the value of glucagons collected at week 24 and glucagons collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal. (NCT01263509)
Timeframe: Baseline and Week 24.

Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)) (Week 52).

The change between the value of glucagons collected at week 52 and glucagons collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal. (NCT01263509)
Timeframe: Baseline and Week 52.

Change From Baseline in Glycosylated Hemoglobin (Final Visit).

The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 52 or final visit and glycosylated hemoglobin collected at baseline. (NCT01263509)
Timeframe: Baseline and Final Visit (up to Week 52).

Change From Baseline in Glycosylated Hemoglobin (Week 12).

The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 12 and glycosylated hemoglobin collected at baseline. (NCT01263509)
Timeframe: Baseline and Week 12.

Change From Baseline in Glycosylated Hemoglobin (Week 16).

The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 16 and glycosylated hemoglobin collected at baseline. (NCT01263509)
Timeframe: Baseline and Week 16.

Change From Baseline in Glycosylated Hemoglobin (Week 20).

The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 20 and glycosylated hemoglobin collected at baseline. (NCT01263509)
Timeframe: Baseline and Week 20.

Change From Baseline in Glycosylated Hemoglobin (Week 24).

The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 24 and glycosylated hemoglobin collected at baseline. (NCT01263509)
Timeframe: Baseline and Week 24.

Change From Baseline in Glycosylated Hemoglobin (Week 28).

The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 28 and glycosylated hemoglobin collected at baseline. (NCT01263509)
Timeframe: Baseline and Week 28.

Change From Baseline in Glycosylated Hemoglobin (Week 32).

The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 32 and glycosylated hemoglobin collected at baseline. (NCT01263509)
Timeframe: Baseline and Week 32.

Change From Baseline in Glycosylated Hemoglobin (Week 36).

The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 36 and glycosylated hemoglobin collected at baseline. (NCT01263509)
Timeframe: Baseline and Week 36.

Change From Baseline in Glycosylated Hemoglobin (Week 40).

The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 40 and glycosylated hemoglobin collected at baseline. (NCT01263509)
Timeframe: Baseline and Week 40.

Change From Baseline in Glycosylated Hemoglobin (Week 44).

The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 44 and glycosylated hemoglobin collected at baseline. (NCT01263509)
Timeframe: Baseline and Week 44.

Change From Baseline in Glycosylated Hemoglobin (Week 48).

The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 48 and glycosylated hemoglobin collected at baseline. (NCT01263509)
Timeframe: Baseline and Week 48.

Change From Baseline in Glycosylated Hemoglobin (Week 52).

The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 52 and glycosylated hemoglobin collected at baseline. (NCT01263509)
Timeframe: Baseline and Week 52.

Change From Baseline in Glycosylated Hemoglobin (Week 8).

Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2)) (Final Visit).

The change between the value of insulin collected at week 52 or final visit and insulin collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal. (NCT01263509)
Timeframe: Baseline and Final Visit (up to Week 52).

Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2)) (Week 12).

The change between the value of insulin collected at week 12 and insulin collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal. (NCT01263509)
Timeframe: Baseline and Week 12.

Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2)) (Week 24).

The change between the value of insulin collected at week 24 and insulin collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal. (NCT01263509)
Timeframe: Baseline and Week 24.

Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2)) (Week 52).

The change between the value of insulin collected at week 52 and insulin collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal. (NCT01263509)
Timeframe: Baseline and Week 52.

Number of Participants With Adverse Events.

A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug and within 30 days after receiving the last dose of study drug. A TEAE may also be a pre-treatment adverse event or a concurrent medical condition diagnosed prior to the date of first dose of study drug, which increases in intensity after the start of dosing. Adverse events data with onset occurring more than 30 days after last dose of study drug (AE start date - last dose date >30) will be listed, but not included in the summary tables below. (NCT01263509)
Timeframe: 52 Weeks.

Change From Baseline in Postprandial Incremental Area Under the Curve for Total Triglycerides at Week 16.

The change in postprandial (after eating a meal) incremental area under the plasma concentration-time curve from 0 to 8 hours (AUC (0-8h)) postdose at week 16 relative to baseline. (NCT00655863)
Timeframe: Baseline and Week 16.

Change From Baseline in Postprandial Incremental Area Under the Curve for Total Triglycerides at Week 4.

The change in postprandial incremental area under the plasma concentration-time curve from 0 to 8 hours (AUC(0-8h)) postdose at week 4 relative to baseline. (NCT00655863)
Timeframe: Baseline and Week 4.

Change From Baseline in Adiponectin

The change in adiponectin collected at each week indicated relative to baseline. (NCT00655863)
Timeframe: Baseline, Week 4 and Week 16.

Change From Baseline in Anti-Intercellular Adhesion Molecule (ICAM)

The change in ICAM collected at each week indicated relative to baseline. (NCT00655863)
Timeframe: Baseline, Week 4 and Week 16.

Change From Baseline in Anti-Vascular Cell Adhesion Molecule (VCAM)

The change in VCAM collected at each week indicated relative to baseline. (NCT00655863)
Timeframe: Baseline, Week 4 and Week 16.

Change From Baseline in e-Selectin

The change in e-Selectin collected at each week indicated relative to baseline. (NCT00655863)
Timeframe: Baseline, Week 4 and Week 16.

Change From Baseline in Endothelial Function Through Pulse Wave Tonometry

Pulse wave tonometry performed before the meal and 2 hours postmeal using one recording consisting of 15 to 20 sequentially recorded radial artery waveforms collected at each assessment. (NCT00655863)
Timeframe: Baseline and Week 16.

Change From Baseline in Fasting Plasma Glucose

The change in fasting plasma glucose collected at each week indicated relative to baseline. (NCT00655863)
Timeframe: Baseline, Week 4, Week 8 and Week 16.

Change From Baseline in Glycosylated Hemoglobin

The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at each week indicated relative to baseline. (NCT00655863)
Timeframe: Baseline, Week 8 and Week 16.

Change From Baseline in High-sensitive C-reactive Protein (Hs-CRP)

The change in hs-CRP collected at each week indicated relative to baseline. (NCT00655863)
Timeframe: Baseline, Week 4 and Week 16.

Change From Baseline in Postprandial C-Peptide

The change in postprandial C-peptide collected at each week indicated relative to baseline. (NCT00655863)
Timeframe: Baseline, Week 4 and Week 16.

Change From Baseline in Postprandial Incremental Area Under the Curve Changes for Lipid Parameters.

The change in postprandial incremental area under the plasma concentration-time curve for very-low-density lipoprotein (VLDL) cholesterol, VLDL triglycerides, VLDL2 cholesterol, VLDL2 triglycerides, chylomicron cholesterol, chylomicron triglycerides, intermediate-density lipoprotein (IDL) cholesterol, and IDL triglycerides from 0 to 8 hours postdose at week 4 and week 16 relative to baseline. (NCT00655863)
Timeframe: Baseline, Week 4 and Week 16.

Change From Baseline in Postprandial Incremental Area Under the Curve for Lipoprotein Parameters.

Postprandial incremental area under the curve changes for very-low-density lipoprotein (VLDL) Apo B-48, VLDL Apo B 100, VLDL2 Apo B-48, VLDL2 Apo B 100, chylomicron Apo B-48, chylomicron Apo B 100, and intermediate density lipoprotein (IDL) Apo B-48, IDL Apo B 100, and triglyceride-rich remnant (TRR) lipoproteins from 0 to 8 hours postdose at week 4 and week 16 relative to baseline. (NCT00655863)
Timeframe: Baseline, Week 4 and Week 16.

Change From Baseline in Postprandial Proinsulin

The change in postprandial proinsulin collected at each week indicated relative to baseline. (NCT00655863)
Timeframe: Baseline, Week 4 and Week 16.

Postprandial Changes Over Time From Baseline for Glucagon

Postprandial changes over time at each week indicated relative to baseline. (NCT00655863)
Timeframe: Baseline, Week 4 and Week 16.

Postprandial Changes Over Time From Baseline for Glucagon-like Peptide-1 (GLP-1)

Postprandial changes over time at each week indicated relative to baseline. (NCT00655863)
Timeframe: Baseline, Week 4 and Week 16.

Postprandial Changes Over Time From Baseline for Glucose

Postprandial changes over time at each week indicated relative to baseline. (NCT00655863)
Timeframe: Baseline, Week 4 and Week 16.

Postprandial Changes Over Time From Baseline for Insulin

Postprandial changes over time at each week indicated relative to baseline. (NCT00655863)
Timeframe: Baseline, Week 4 and Week 16.

Change From Baseline to Week 1 in Fasting Plasma Glucose

Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline fasting plasma glucose as covariates. (NCT00328627)
Timeframe: Baseline and Week 1

Change From Baseline to Week 12 in Adiponectin

Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline adiponectin as continuous covariates. (NCT00328627)
Timeframe: Baseline and Week 12

Change From Baseline to Week 12 in Apolipoprotein A1

Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein A1 as continuous covariates. (NCT00328627)
Timeframe: Baseline and Week 12

Change From Baseline to Week 12 in Apolipoprotein A2

Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein A2 as continuous covariates. (NCT00328627)
Timeframe: Baseline and Week 12

Change From Baseline to Week 12 in Apolipoprotein B

Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein B as continuous covariates. (NCT00328627)
Timeframe: Baseline and Week 12

Change From Baseline to Week 12 in Apolipoprotein C-III

Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein C-III as continuous covariates. (NCT00328627)
Timeframe: Baseline and Week 12

Change From Baseline to Week 12 in Body Weight

Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline weight as continuous covariates. (NCT00328627)
Timeframe: Baseline and Week 12

Change From Baseline to Week 12 in C-peptide Levels

Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline C-peptide as continuous covariates. (NCT00328627)
Timeframe: Baseline and Week 12

Change From Baseline to Week 12 in Calculated HOMA Beta-cell Function

"The Homeostasis Model Assessment (HOMA) estimates steady state beta cell function (%B) as a percentage of a normal reference population.~HOMA %B = 20 * insulin (µIU/mL) / fasting plasma glucose (mmol/L) - 3.5. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HOMA beta cell function as continuous covariates." (NCT00328627)
Timeframe: Baseline and Week 12

Change From Baseline to Week 12 in Calculated HOMA Insulin Resistance

"The Homeostasis Model Assessment of insulin resistance (HOMA IR) measures insulin resistance based on fasting glucose and insulin measurements:~HOMA IR = fasting plasma insulin (µIU/mL) * fasting plasma glucose (mmol/L) / 22.5.~A higher number indicates a greater degree of insulin resistance. Least Squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and HOMA-IR as continuous covariates." (NCT00328627)
Timeframe: Baseline and Week 12

Change From Baseline to Week 12 in Fasting Plasma Glucose

Change From Baseline to Week 12 in Fasting Proinsulin

Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline proinsulin as continuous covariates. (NCT00328627)
Timeframe: Baseline and Week 12

Change From Baseline to Week 12 in Free Fatty Acids

Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline free fatty acid as continuous covariates. (NCT00328627)
Timeframe: Baseline and Week 12

Change From Baseline to Week 12 in HbA1c

"The change from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) at week 12.~Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HbA1c as continuous covariates." (NCT00328627)
Timeframe: Baseline and Week 12

Change From Baseline to Week 12 in High-Density Lipoprotein Cholesterol

Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HDL cholesterol as continuous covariates. (NCT00328627)
Timeframe: Baseline and Week 12

Change From Baseline to Week 12 in High-sensitivity C-Reactive Protein

Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline hsCRP as continuous covariates. (NCT00328627)
Timeframe: Baseline and Week 12

Change From Baseline to Week 12 in IDL Particles

"The change from Baseline in levels of IDL particles was assessed by NMR lipid fractionation.~Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR IDL particles as continuous covariates." (NCT00328627)
Timeframe: Baseline and Week 12

Change From Baseline to Week 12 in Insulin Levels

Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline insulin as continuous covariates. (NCT00328627)
Timeframe: Baseline and Week 12

Change From Baseline to Week 12 in Low-Density Lipoprotein Cholesterol

Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline LDL cholesterol as continuous covariates. (NCT00328627)
Timeframe: Baseline and Week 12

Change From Baseline to Week 12 in Mean HDL Particle Size

The change from Baseline in mean HDL particle size was assessed by NMR lipid fractionation. Least squares means are from are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline mean HDL particle size as continuous covariates. (NCT00328627)
Timeframe: Baseline and Week 12

Change From Baseline to Week 12 in Mean LDL Particle Size

"The change from Baseline in mean LDL particle size was assessed by NMR lipid fractionation.~Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline mean LDL particle size as continuous covariates." (NCT00328627)
Timeframe: Baseline and Week 12

Change From Baseline to Week 12 in Mean VLDL Particle Size

"The change from Baseline in mean VLDL particle size was assessed by NMR lipid fractionation.~Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline mean VLDL particle size as continuous covariates." (NCT00328627)
Timeframe: Baseline and Week 12

Change From Baseline to Week 12 in NMR Lipid Fractionation Total Triglycerides

"NMR lipid fractionation was used to assess the change from Baseline in total triglyceride levels at Week 12.~Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR total triglycerides as continuous covariates." (NCT00328627)
Timeframe: Baseline and Week 12

Change From Baseline to Week 12 in Plasminogen Activator Inhibitor-1

Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline PAI-1 as continuous covariates. (NCT00328627)
Timeframe: Baseline and Week 12

Change From Baseline to Week 12 in Proinsulin/Insulin Ratio

"The ratio of proinsulin to insulin was calculated as proinsulin (pmol/L) / insulin (μIU/mL).~Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline proinsulin/insulin ratio as continuous covariates." (NCT00328627)
Timeframe: Baseline and Week 12

Change From Baseline to Week 12 in Total Cholesterol Levels

Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline total cholesterol as continuous covariates. (NCT00328627)
Timeframe: Baseline and Week 12

Change From Baseline to Week 12 in Triglyceride Levels

Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline triglycerides as continuous covariates. (NCT00328627)
Timeframe: Baseline and Week 12

Change From Baseline to Week 12 in VLDL / Chylomicron Triglycerides

The change from Baseline in VLDL/chylomicron triglyceride levels was assessed by NMR lipid fractionation. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR VLDL/chylomicron triglycerides as continuous covariates. (NCT00328627)
Timeframe: Baseline and Week 12

Change From Baseline to Week 16 in C-peptide Levels

Change From Baseline to Week 16 in Fasting Plasma Glucose

Change From Baseline to Week 16 in Fasting Proinsulin

Change From Baseline to Week 16 in HbA1c

The change from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) at week 16. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HbA1c as continuous covariates. (NCT00328627)
Timeframe: Baseline and Week 16

Change From Baseline to Week 16 in High-Density Lipoprotein Cholesterol

Change From Baseline to Week 16 in Insulin Levels

Change From Baseline to Week 16 in Low-Density Lipoprotein Cholesterol

Change From Baseline to Week 16 in Proinsulin/Insulin Ratio

Change From Baseline to Week 16 in Total Cholesterol Levels

Change From Baseline to Week 16 in Triglyceride Levels

Change From Baseline to Week 2 in Fasting Plasma Glucose

Change From Baseline to Week 20 in Body Weight

Change From Baseline to Week 20 in C-peptide Levels

Change From Baseline to Week 20 in Fasting Plasma Glucose

Change From Baseline to Week 20 in Fasting Proinsulin

Change From Baseline to Week 20 in HbA1c

"The change from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) at week 20.~Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HbA1c as continuous covariates." (NCT00328627)
Timeframe: Baseline and Week 20

Change From Baseline to Week 20 in High-Density Lipoprotein Cholesterol

Change From Baseline to Week 20 in Insulin Levels

Change From Baseline to Week 20 in Low-Density Lipoprotein Cholesterol

Change From Baseline to Week 20 in Proinsulin/Insulin Ratio

Change From Baseline to Week 20 in Total Cholesterol Levels

Change From Baseline to Week 20 in Triglyceride Levels

Change From Baseline to Week 26 in Adiponectin

Change From Baseline to Week 26 in Apolipoprotein A1

Change From Baseline to Week 26 in Apolipoprotein A2

Change From Baseline to Week 26 in Apolipoprotein B

Change From Baseline to Week 26 in Apolipoprotein C-III

Change From Baseline to Week 26 in Body Weight

Change From Baseline to Week 26 in C-peptide Levels

Change From Baseline to Week 26 in Calculated HOMA Beta-cell Function

"The Homeostasis Model Assessment (HOMA) estimates steady state beta cell function (%B) as a percentage of a normal reference population.~HOMA %B = 20 * insulin (µIU/mL) / fasting plasma glucose (mmol/L) - 3.5. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HOMA beta cell function as continuous covariates." (NCT00328627)
Timeframe: Baseline and Week 26

Change From Baseline to Week 26 in Calculated HOMA Insulin Resistance

"The Homeostasis Model Assessment of insulin resistance (HOMA IR) measures insulin resistance based on fasting glucose and insulin measurements:~HOMA IR = fasting plasma insulin (µIU/mL) * fasting plasma glucose (mmol/L) / 22.5.~A higher number indicates a greater degree of insulin resistance. Least Squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and HOMA-IR as continuous covariates." (NCT00328627)
Timeframe: Baseline and Week 26

Change From Baseline to Week 26 in Fasting Plasma Glucose

Change From Baseline to Week 26 in Fasting Proinsulin

Change From Baseline to Week 26 in Free Fatty Acids

Change From Baseline to Week 26 in Glycosylated Hemoglobin (HbA1c) (Grouped Analysis)

"The change from Baseline to Week 26 in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound).~The primary analysis compared the groupings (combinations of individual treatment groups) of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone (Pioglitazone Alone)." (NCT00328627)
Timeframe: Baseline and Week 26

Change From Baseline to Week 26 in HbA1c

The change from Baseline to Week 26 in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound). (NCT00328627)
Timeframe: Baseline and Week 26

Change From Baseline to Week 26 in High-Density Lipoprotein Cholesterol

Change From Baseline to Week 26 in High-sensitivity C-Reactive Protein

Change From Baseline to Week 26 in IDL Particles

Change From Baseline to Week 26 in Insulin Levels

Change From Baseline to Week 26 in Low-Density Lipoprotein Cholesterol

Change From Baseline to Week 26 in Mean HDL Particle Size

Change From Baseline to Week 26 in Mean LDL Particle Size

Change From Baseline to Week 26 in Mean VLDL Particle Size

Change From Baseline to Week 26 in NMR Lipid Fractionation Total Triglycerides

"NMR lipid fractionation was used to assess the change from Baseline in total triglyceride levels at Week 26.~Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR total triglycerides as continuous covariates." (NCT00328627)
Timeframe: Baseline and Week 26

Change From Baseline to Week 26 in Plasminogen Activator Inhibitor-1

Change From Baseline to Week 26 in Proinsulin/Insulin Ratio

Change From Baseline to Week 26 in Total Cholesterol Levels

Change From Baseline to Week 26 in Triglyceride Levels

Change From Baseline to Week 26 in VLDL / Chylomicron Triglycerides

Change From Baseline to Week 4 in C-peptide Levels

Change From Baseline to Week 4 in Fasting Plasma Glucose

Change From Baseline to Week 4 in Fasting Proinsulin

Change From Baseline to Week 4 in HbA1c

The change from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) at week 4. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HbA1c as continuous covariates. (NCT00328627)
Timeframe: Baseline and Week 4

Change From Baseline to Week 4 in High-Density Lipoprotein Cholesterol

Change From Baseline to Week 4 in Insulin Levels

Change From Baseline to Week 4 in Low-Density Lipoprotein Cholesterol

Change From Baseline to Week 4 in Proinsulin/Insulin Ratio

Change From Baseline to Week 4 in Total Cholesterol Levels

Change From Baseline to Week 4 in Triglyceride Levels

Change From Baseline to Week 8 in Body Weight

Change From Baseline to Week 8 in C-peptide Levels

Change From Baseline to Week 8 in Fasting Plasma Glucose

Change From Baseline to Week 8 in Fasting Proinsulin

Change From Baseline to Week 8 in HbA1c

The change from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) at week 8. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HbA1c as continuous covariates. (NCT00328627)
Timeframe: Baseline and Week 8

Change From Baseline to Week 8 in High-Density Lipoprotein Cholesterol

Change From Baseline to Week 8 in Insulin Levels

Change From Baseline to Week 8 in Low-Density Lipoprotein Cholesterol

Change From Baseline to Week 8 in Proinsulin/Insulin Ratio

Change From Baseline to Week 8 in Total Cholesterol Levels

Change From Baseline to Week 8 in Triglyceride Levels

Percentage of Participants Meeting Rescue Criteria

"Rescue was defined as meeting 1 of the following criteria, confirmed by a 2nd sample drawn within 5 days of the first and analyzed by the central laboratory:~After the Week 1 Visit but prior to the Week 4 Visit: a single fasting plasma glucose ≥300 mg/dL;~From the Week 4 Visit but prior to the Week 8 Visit: a single fasting plasma glucose ≥275 mg/dL;~From the Week 8 Visit but prior to the Week 12 Visit: a single fasting plasma glucose ≥250 mg/dL;~From the Week 12 Visit through the End-of-Treatment Visit: HbA1c ≥8.5% and ≤0.5% reduction in HbA1c as compared with Baseline HbA1c." (NCT00328627)
Timeframe: From Week 1 to Week 26

Percentage of Participants Meeting Rescue Criteria (Grouped Analysis)

Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥ 0.5%

Clinical response at Week 26 was assessed by the percentage of participants with a decrease from Baseline in HbA1c of greater than or equal to 0.5%. (NCT00328627)
Timeframe: Baseline and Week 26

Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥ 0.5% (Grouped Analysis)

"Clinical response at Week 26 was assessed by the percentage of participants with a decrease from Baseline in HbA1c of greater than or equal to 0.5%.~This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone." (NCT00328627)
Timeframe: Baseline and Week 26

Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥ 1.5%

Clinical response at Week 26 was assessed by the percentage of participants with a decrease from Baseline in HbA1c of greater than or equal to 1.5%. (NCT00328627)
Timeframe: Baseline and Week 26

Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥ 1.5% (Grouped Analysis)

"Clinical response at Week 26 was assessed by the percentage of participants with a decrease from Baseline in HbA1c of greater than or equal to 1.5%.~This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone." (NCT00328627)
Timeframe: Baseline and Week 26

Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥ 1%

Clinical response at Week 26 was assessed by the percentage of participants with a decrease from Baseline in HbA1c of greater than or equal to 1%. (NCT00328627)
Timeframe: Baseline and Week 26

Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥ 1% (Grouped Analysis)

"Clinical response at Week 26 was assessed by the percentage of participants with a decrease from Baseline in HbA1c of greater than or equal to 1%.~This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone." (NCT00328627)
Timeframe: Baseline and Week 26

Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥ 2.0% (Grouped Analysis)

"Clinical response at Week 26 was assessed by the percentage of participants with a decrease from Baseline in HbA1c of greater than or equal to 2.0%.~This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone." (NCT00328627)
Timeframe: Baseline and Week 26.

Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥ 2%

Clinical response at Week 26 was assessed by the percentage of participants with a decrease from Baseline in HbA1c of greater than or equal to 2%. (NCT00328627)
Timeframe: Baseline and Week 26

Percentage of Participants With Glycosylated Hemoglobin ≤ 6.5%

Clinical response at Week 26 was assessed by the percentage of participants with HbA1c less than or equal to 6.5%. (NCT00328627)
Timeframe: Week 26

Percentage of Participants With Glycosylated Hemoglobin ≤ 6.5% (Grouped Analysis)

"Clinical response at Week 26 was assessed by the percentage of participants with HbA1c less than or equal to 6.5%.~This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone." (NCT00328627)
Timeframe: Week 26

Percentage of Participants With Glycosylated Hemoglobin ≤ 7.0% (Grouped Analysis)

"Clinical response at Week 26 was assessed by the percentage of participants with HbA1c less than or equal to 7%.~This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone." (NCT00328627)
Timeframe: Week 26

Percentage of Participants With Glycosylated Hemoglobin ≤ 7.5%

Clinical response at Week 26 was assessed by the percentage of participants with HbA1c less than or equal to 7.5%. (NCT00328627)
Timeframe: Week 26

Percentage of Participants With Glycosylated Hemoglobin ≤ 7.5% (Grouped Analysis)

"Clinical response at Week 26 was assessed by the percentage of participants with HbA1c less than or equal to 7.5%.~This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone." (NCT00328627)
Timeframe: Week 26

Percentage of Participants With Glycosylated Hemoglobin ≤ 7%

Clinical response at Week 26 was assessed by the percentage of participants with HbA1c less than or equal to 7%. (NCT00328627)
Timeframe: Week 26

Percentage of Participants With Marked Hyperglycemia

Marked hyperglycemia is defined as fasting plasma glucose greater than or equal to 200 mg/dL (11.10 mmol/L). (NCT00328627)
Timeframe: From Week 1 to Week 26

Percentage of Participants With Marked Hyperglycemia (Grouped Analysis)

"Marked hyperglycemia is defined as fasting plasma glucose greater than or equal to 200 mg/dL (11.10 mmol/L).~This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone." (NCT00328627)
Timeframe: From Week 1 to Week 26

Change From Baseline in Adiponectin Over Time (Grouped Analysis)

Change from Baseline in adiponectin was assessed at Weeks 12 and 26. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline adiponectin as continuous covariates. (NCT00328627)
Timeframe: Baseline and Weeks 12 and 26.

Change From Baseline in Apolipoprotein A1 Over Time (Grouped Analysis)

Change from Baseline in Apolipoprotein A1 was assessed at Weeks 12 and 26. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein A1 as continuous covariates. (NCT00328627)
Timeframe: Baseline and Weeks 12 and 26.

Change From Baseline in Apolipoprotein A2 Over Time (Grouped Analysis)

Change from Baseline in Apolipoprotein A2 was assessed at Weeks 12 and 26. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein A2 as continuous covariates. (NCT00328627)
Timeframe: Baseline and Weeks 12 and 26

Change From Baseline in Apolipoprotein B Over Time (Grouped Analysis)

Change from Baseline in Apolipoprotein B was assessed at Weeks 12 and 26. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein B as continuous covariates. (NCT00328627)
Timeframe: Baseline and Weeks 12 and 26

Change From Baseline in Apolipoprotein C-III Over Time (Grouped Analysis)

Change from Baseline in apolipoprotein C-III was assessed at Weeks 12 and 26. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein C-III as continuous covariates. (NCT00328627)
Timeframe: Baseline and Weeks 12 and 26

Change From Baseline in Body Weight Over Time (Grouped Analysis)

Change from Baseline in body weight was assessed at Weeks 8, 12, 20 and 26. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline weight as continuous covariates. (NCT00328627)
Timeframe: Baseline and Weeks 8, 12, 20 and 26.

Change From Baseline in C-peptide Over Time (Grouped Analysis)

"C-peptide is a byproduct created when the hormone insulin is produced and is measured by a blood test. Change from Baseline was assessed at Weeks 4, 8, 12, 16, 20 and 26.~This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline C-peptide as continuous covariates." (NCT00328627)
Timeframe: Baseline and Weeks 4, 8, 12, 16, 20 and 26.

Change From Baseline in Calculated Homeostatic Model Assessment Insulin Resistance (HOMA IR) (Grouped Analysis)

"HOMA IR measures insulin resistance based on fasting glucose and insulin measurements:~HOMA IR = fasting plasma insulin (µIU/mL) * fasting plasma glucose (mmol/L) / 22.5.~A higher number indicates a greater insulin resistance. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone.~Least Squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and HOMA-IR as continuous covariates." (NCT00328627)
Timeframe: Baseline and Weeks 12 and 26.

Change From Baseline in Fasting Plasma Glucose Over Time (Grouped Analysis)

"The change from Baseline in fasting plasma glucose was assessed at weeks 1, 2, 4, 8, 12, 16, 20 and 26.~This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline fasting plasma glucose as covariates." (NCT00328627)
Timeframe: Baseline and Weeks 1, 2, 4, 8, 12, 16, 20 and 26.

Change From Baseline in Fasting Proinsulin Over Time (Grouped Analysis)

"Proinsulin is a precursor to insulin, and was measured as an indicator of pancreatic function. The change from Baseline in fasting proinsulin was assessed at Weeks 4, 8, 12, 16, 20 and 26.~This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and proinsulin as continuous covariates." (NCT00328627)
Timeframe: Baseline and Weeks 4, 8, 12, 16, 20 and 26.

Change From Baseline in Free Fatty Acids Over Time (Grouped Analysis)

Change from Baseline in free fatty acids (FFA) was assessed at Weeks 12 and 26. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline free fatty acid as continuous covariates. (NCT00328627)
Timeframe: Baseline and Weeks 12 and 26.

Change From Baseline in HbA1c Over Time (Grouped Analysis)

"The change from Baseline to Weeks 4, 8, 12, 16 and 20 in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound).~This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an analysis of covariance (ANCOVA) model with treatment and geographic region as class variables, and baseline metformin dose and HbA1c as continuous covariates." (NCT00328627)
Timeframe: Baseline and Weeks 4, 8, 12, 16 and 20.

Change From Baseline in High Density Lipoprotein (HDL) Particles Over Time (Grouped Analysis)

"The change from Baseline in levels of total, large, medium and small HDL particles was assessed by NMR fractionation at Weeks 12 and 26.~This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR HDL particles as continuous covariates." (NCT00328627)
Timeframe: Baseline and Weeks 12 and 26.

Change From Baseline in High-Density Lipoprotein Cholesterol Over Time (Grouped Analysis)

"Change from Baseline in high-density lipoprotein cholesterol (HDL-C) was assessed at Weeks 4, 8, 12, 16, 20 and 26.~This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HDL cholesterol as continuous covariates." (NCT00328627)
Timeframe: Baseline and Weeks 4, 8, 12, 16, 20 and 26.

Change From Baseline in High-sensitivity C-Reactive Protein Over Time (Grouped Analysis)

"Change from Baseline in high-sensitivity C-Reactive Protein (hsCRP) was assessed at Weeks 12 and 26.~This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline hsCRP as continuous covariates." (NCT00328627)
Timeframe: Baseline and Weeks 12 and 26.

Change From Baseline in Homeostatic Model Assessment Beta Cell Function (Grouped Analysis)

"The homeostatic model assessment estimates steady state beta cell function as a percentage of a normal reference population (%B).~HOMA %B = 20 * insulin (µIU/mL) / fasting plasma glucose (mmol/L) - 3.5.~This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HOMA beta cell function as continuous covariates." (NCT00328627)
Timeframe: Baseline and Weeks 12 and 26

Change From Baseline in Insulin Over Time (Grouped Analysis)

The change from Baseline in fasting insulin was assessed at Weeks 4, 8, 12, 16, 20 and 26. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline insulin as continuous covariates. (NCT00328627)
Timeframe: Baseline and Weeks 4, 8, 12, 16, 20 and 26.

Change From Baseline in Intermediate Density Lipoprotein (IDL) Particles Over Time (Grouped Analysis)

"The change from Baseline in levels of IDL particles was assessed by NMR lipid fractionation at Weeks 12 and 26.~This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR IDL particles as continuous covariates." (NCT00328627)
Timeframe: Baseline and Weeks 12 and 26

Change From Baseline in Low Density Lipoprotein (LDL) Particles Over Time (Grouped Analysis)

"The change from Baseline in levels of total, large, medium-small, total small and very small LDL particles was assessed by NMR fractionation at Weeks 12 and 26.~This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR LDL particles as continuous covariates." (NCT00328627)
Timeframe: Baseline and Weeks 12 and 26

Change From Baseline in Low-Density Lipoprotein Cholesterol Over Time (Grouped Analysis)

"Change from Baseline in low-density lipoprotein cholesterol (LDL-C) was assessed at Weeks 4, 8, 12, 16, 20 and 26.~This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline LDL cholesterol as continuous covariates." (NCT00328627)
Timeframe: Baseline and Weeks 4, 8, 12, 16, 20 and 26.

Change From Baseline in Mean HDL Particle Size Over Time (Grouped Analysis)

"The change from Baseline in mean HDL particle size was assessed by NMR lipid fractionation at Weeks 12 and 26.~This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline mean HDL particle size as continuous covariates." (NCT00328627)
Timeframe: Baseline and Weeks 12 and 26

Change From Baseline in Mean LDL Particle Size Over Time (Grouped Analysis)

"The change from Baseline in mean LDL particle size was assessed by NMR lipid fractionation at Weeks 12 and 26.~This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone.~Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline mean LDL particle size as continuous covariates." (NCT00328627)
Timeframe: Baseline and Weeks 12 and 26

Change From Baseline in Mean VLDL Particle Size Over Time (Grouped Analysis)

"The change from Baseline in mean VLDL particle size was assessed by NMR lipid fractionation at Weeks 12 and 26.~This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline mean VLDL particle size as continuous covariates." (NCT00328627)
Timeframe: Baseline and Weeks 12 and 26

Change From Baseline in Nuclear Magnetic Resonance Lipid Fractionation Total Triglycerides Over Time (Grouped Analysis)

"Nuclear Magnetic Resonance (NMR) lipid fractionation was used to assess the change from Baseline in total triglyceride levels at Weeks 12 and 26.~This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR total triglycerides as continuous covariates." (NCT00328627)
Timeframe: Baseline and Weeks 12 and 26.

Change From Baseline in Plasminogen Activator Inhibitor-1 Over Time (Grouped Analysis)

"Change from Baseline in plasminogen activator inhibitor-1 (PAI-1) was assessed at Weeks 12 and 26.~This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline PAI-1 as continuous covariates." (NCT00328627)
Timeframe: Baseline and Weeks 12 and 26.

Change From Baseline in Proinsulin/Insulin Ratio Over Time (Grouped Analysis)

"The ratio of proinsulin to insulin was calculated as proinsulin (pmol/L) / insulin (μIU/mL) at weeks 4, 8, 12, 16, 20 and 26 relative to the Baseline value.~This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline proinsulin/insulin ratio as continuous covariates." (NCT00328627)
Timeframe: Baseline and Weeks 4, 8, 12, 16, 20 and 26.

Change From Baseline in Total Cholesterol Over Time (Grouped Analysis)

Change from Baseline in total cholesterol was assessed at Weeks 4, 8, 12, 16, 20 and 26. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline total cholesterol as continuous covariates. (NCT00328627)
Timeframe: Baseline and Weeks 4, 8, 12, 16, 20 and 26.

Change From Baseline in Triglycerides Over Time (Grouped Analysis)

Change from Baseline in triglycerides was assessed at Weeks 4, 8, 12, 16, 20 and 26. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline triglycerides as continuous covariates. (NCT00328627)
Timeframe: Baseline and Weeks 4, 8, 12, 16, 20 and 26.

Change From Baseline in Very Low Density Lipoprotein (VLDL) / Chylomicron Particles Over Time (Grouped Analysis)

"The change from Baseline in levels of total VLDL/chylomicron particles and large VLDL/chylomicron particles was assessed by NMR lipid fractionation at Weeks 12 and 26.~This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR VLDL/chylomicron particles as continuous covariates." (NCT00328627)
Timeframe: Baseline and Weeks 12 and 26

Change From Baseline in VLDL / Chylomicron Triglycerides Over Time (Grouped Analysis)

"The change from Baseline in levels of VLDL/chylomicron triglycerides was assessed by NMR lipid fractionation at Weeks 12 and 26.~This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR VLDL/chylomicron triglycerides as continuous covariates." (NCT00328627)
Timeframe: Baseline and Weeks 12 and 26

Change From Baseline in VLDL Particles Over Time (Grouped Analysis)

"The change from Baseline in levels of medium VLDL particles and small VLDL particles was assessed by NMR fractionation at Weeks 12 and 26.~This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR VLDL particles as continuous covariates." (NCT00328627)
Timeframe: Baseline and Weeks 12 and 26

Change From Baseline to Week 12 in HDL Particles

"The change from Baseline in levels of total, large, medium and small HDL particles was assessed by NMR lipid fractionation.~Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR HDL particles as continuous covariates." (NCT00328627)
Timeframe: Baseline and Week 12

Change From Baseline to Week 12 in LDL Particles

"The change from Baseline in levels of total, large, medium-small, total small and very small LDL particles was assessed by NMR lipid fractionation.~Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR LDL particles as continuous covariates." (NCT00328627)
Timeframe: Baseline and Week 12

Change From Baseline to Week 12 in VLDL / Chylomicron Particles

"The change from Baseline in levels of total VLDL/chylomicron particles and large VLDL/chylomicron particles was assessed by NMR lipid fractionation.~Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR VLDL/chylomicron particles as continuous covariates." (NCT00328627)
Timeframe: Baseline and Week 12

Change From Baseline to Week 12 in VLDL Particles

"The change from Baseline in levels of medium VLDL particles and small VLDL particles was assessed by NMR lipid fractionation.~Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR VLDL particles as continuous covariates." (NCT00328627)
Timeframe: Baseline and Week 12

Change From Baseline to Week 26 in HDL Particles

Change From Baseline to Week 26 in LDL Particles

Change From Baseline to Week 26 in VLDL / Chylomicron Particles

Change From Baseline to Week 26 in VLDL Particles

Intervention	mg/dL (Least Squares Mean)
Placebo QD	2.5
Alogliptin 12.5 mg QD	-14.3
Alogliptin 25 mg QD	-19.8

Intervention	pmol/L (Least Squares Mean)
Placebo QD	-2.8
Alogliptin 12.5 mg QD	-3.2
Alogliptin 25 mg QD	-8.5

Intervention	pmol/L (Least Squares Mean)
Placebo QD	-0.6
Alogliptin 12.5 mg QD	-4.5
Alogliptin 25 mg QD	-6.6

Intervention	pmol/L (Least Squares Mean)
Placebo QD	-0.8
Alogliptin 12.5 mg QD	-6.0
Alogliptin 25 mg QD	-6.3

Intervention	pmol/L (Least Squares Mean)
Placebo QD	-2.1
Alogliptin 12.5 mg QD	-6.1
Alogliptin 25 mg QD	-7.4

Intervention	pmol/L (Least Squares Mean)
Placebo QD	2.9
Alogliptin 12.5 mg QD	-4.7
Alogliptin 25 mg QD	-10.4

Intervention	pg/mL (Mean)
Placebo QD	-1.2
Alogliptin 12.5 mg QD	0.8
Alogliptin 25 mg QD	2.8

Intervention	percentage of Glycosylated Hemoglobin (Least Squares Mean)
Placebo QD	-0.02
Alogliptin 12.5 mg QD	-0.56
Alogliptin 25 mg QD	-0.59

Intervention	percentage of Glycosylated Hemoglobin (Least Squares Mean)
Placebo QD	-0.13
Alogliptin 12.5 mg QD	-0.57
Alogliptin 25 mg QD	-0.66

Intervention	percentage of Glycosylated Hemoglobin (Least Squares Mean)
Placebo QD	-0.12
Alogliptin 12.5 mg QD	-0.59
Alogliptin 25 mg QD	-0.65

Intervention	percentage of Glycosylated Hemoglobin (Least Squares Mean)
Placebo QD	-0.11
Alogliptin 12.5 mg QD	-0.37
Alogliptin 25 mg QD	-0.45

Intervention	ϻIU/mL (Least Squares Mean)
Placebo QD	-1.66
Alogliptin 12.5 mg QD	0.94
Alogliptin 25 mg QD	-1.60

Intervention	ϻIU/mL (Least Squares Mean)
Placebo QD	-0.41
Alogliptin 12.5 mg QD	0.55
Alogliptin 25 mg QD	-1.46

Intervention	ϻIU/mL (Least Squares Mean)
Placebo QD	-1.32
Alogliptin 12.5 mg QD	-0.32
Alogliptin 25 mg QD	-1.12

Intervention	ϻIU/mL (Least Squares Mean)
Placebo QD	0.87
Alogliptin 12.5 mg QD	0.14
Alogliptin 25 mg QD	-1.27

Intervention	ϻIU/mL (Least Squares Mean)
Placebo QD	-0.35
Alogliptin 12.5 mg QD	1.18
Alogliptin 25 mg QD	0.94

Intervention	ratio (Least Squares Mean)
Placebo QD	0.025
Alogliptin 12.5 mg QD	-0.043
Alogliptin 25 mg QD	-0.047

Intervention	ratio (Least Squares Mean)
Placebo QD	0.001
Alogliptin 12.5 mg QD	-0.044
Alogliptin 25 mg QD	-0.039

Intervention	ratio (Least Squares Mean)
Placebo QD	0.119
Alogliptin 12.5 mg QD	-0.043
Alogliptin 25 mg QD	-0.040

Intervention	ratio (Least Squares Mean)
Placebo QD	0.046
Alogliptin 12.5 mg QD	-0.040
Alogliptin 25 mg QD	-0.038

Intervention	ratio (Least Squares Mean)
Placebo QD	0.008
Alogliptin 12.5 mg QD	-0.043
Alogliptin 25 mg QD	-0.063

Intervention	ratio (Least Squares Mean)
Placebo QD	0.014
Alogliptin 12.5 mg QD	-0.054
Alogliptin 25 mg QD	-0.038

Intervention	kg (Least Squares Mean)
Placebo	-0.30
Alogliptin 12.5 mg QD	0.79
Alogliptin 25 mg QD	0.61

Intervention	kg (Least Squares Mean)
Placebo	-0.20
Alogliptin 12.5 mg QD	0.60
Alogliptin 25 mg QD	0.68

Intervention	kg (Least Squares Mean)
Placebo	-0.27
Alogliptin 12.5 mg QD	0.47
Alogliptin 25 mg QD	0.33

Intervention	ng/mL (Least Squares Mean)
Placebo	-0.020
Alogliptin 12.5 mg QD	0.162
Alogliptin 25 mg QD	0.206

Intervention	ng/mL (Least Squares Mean)
Placebo	-0.007
Alogliptin 12.5 mg QD	0.222
Alogliptin 25 mg QD	0.153

Intervention	ng/mL (Least Squares Mean)
Placebo	-0.016
Alogliptin 12.5 mg QD	-0.001
Alogliptin 25 mg QD	0.122

Intervention	ng/mL (Least Squares Mean)
Placebo	-0.215
Alogliptin 12.5 mg QD	-0.140
Alogliptin 25 mg QD	-0.153

Intervention	ng/mL (Least Squares Mean)
Placebo	-0.041
Alogliptin 12.5 mg QD	0.122
Alogliptin 25 mg QD	0.136