uracil and Weight Gain studies

Research Excerpts

Excerpt	Relevance	Reference
"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)
"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)
"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)
"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)
"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)
" 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 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)
"Ecological evidence suggests that niacin (nicotinamide and nicotinic acid) fortification may be involved in the increased prevalence of obesity and type 2 diabetes, both of which are associated with insulin resistance and epigenetic changes."	3.79	Nicotinamide supplementation induces detrimental metabolic and epigenetic changes in developing rats. ( Cao, JM; Cao, Y; Gong, XJ; Guo, J; Guo, M; Li, D; Lun, YZ; Luo, N; Sun, WP; Tian, YJ; Zhou, SS, 2013)
" 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)

Research

Studies (11)

Authors

Clinical Trials (3)

Trial Overview

Trial Outcomes

Change From Baseline in Body Weight (Week 12).

Timeframe	Studies, this research(%)	All Research%
pre-1990	0 (0.00)	18.7374
1990's	1 (9.09)	18.2507
2000's	1 (9.09)	29.6817
2010's	7 (63.64)	24.3611
2020's	2 (18.18)	2.80

Authors	Studies
Ferreira, JP	1
Rossignol, P	1
Bakris, G	1
Mehta, C	1
White, WB	1
Zannad, F	1
Sohn, JH	1
Mutlu, B	1
Latorre-Muro, P	1
Liang, J	1
Bennett, CF	1
Sharabi, K	1
Kantorovich, N	1
Jedrychowski, M	1
Gygi, SP	1
Banks, AS	1
Puigserver, P	1
Rosenstock, J	2
Wilson, C	2
Fleck, P	2
Li, D	1
Tian, YJ	1
Guo, J	1
Sun, WP	1
Lun, YZ	1
Guo, M	1
Luo, N	1
Cao, Y	1
Cao, JM	1
Gong, XJ	1
Zhou, SS	1
Kaku, K	1
Mori, M	1
Kanoo, T	1
Katou, M	1
Seino, Y	1
Del Prato, S	1
Chaudhari, P	1
Rendell, MS	1
Gross, JL	1
Fleck, PR	1
Wilson, CA	1
Mekki, Q	1
Davidson, EP	1
Coppey, LJ	1
Dake, B	1
Yorek, MA	1
Scheen, AJ	1
Kusunoki, Y	1
Katsuno, T	1
Myojin, M	1
Miyakoshi, K	1
Ikawa, T	1
Matsuo, T	1
Ochi, F	1
Tokuda, M	1
Murai, K	1
Miuchi, M	1
Hamaguchi, T	1
Miyagawa, J	1
Namba, M	1
Giesecke, D	1
Gallenmüller, P	1
Tiemeyer, W	1
Gropp, J	1

Trial	Phase	Enrollment	Study Type	Start Date	Status
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
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
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
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

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).

Intervention	kg (Least Squares Mean)
Placebo	0.50
Alogliptin 12.5 mg QD	0.44
Alogliptin 25 mg QD	0.31

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).

Intervention	kg (Least Squares Mean)
Placebo	0.73
Alogliptin 12.5 mg QD	0.55
Alogliptin 25 mg QD	0.45

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).

Intervention	kg (Least Squares Mean)
Placebo	0.63
Alogliptin 12.5 mg QD	0.68
Alogliptin 25 mg QD	0.60

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).

Intervention	kg (Least Squares Mean)
Placebo	0.39
Alogliptin 12.5 mg QD	0.10
Alogliptin 25 mg QD	0.18

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).

Intervention	ng/mL (Least Squares Mean)
Placebo	0.207
Alogliptin 12.5 mg QD	0.333
Alogliptin 25 mg QD	0.390

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).

Intervention	ng/mL (Least Squares Mean)
Placebo	0.241
Alogliptin 12.5 mg QD	0.319
Alogliptin 25 mg QD	0.396

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).

Intervention	ng/mL (Least Squares Mean)
Placebo	0.239
Alogliptin 12.5 mg QD	0.318
Alogliptin 25 mg QD	0.281

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).

Intervention	ng/mL (Least Squares Mean)
Placebo	-0.083
Alogliptin 12.5 mg QD	0.199
Alogliptin 25 mg QD	0.042

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).

Intervention	ng/mL (Least Squares Mean)
Placebo	-0.023
Alogliptin 12.5 mg QD	0.132
Alogliptin 25 mg QD	0.453

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).

Intervention	ng/mL (Least Squares Mean)
Placebo	-0.024
Alogliptin 12.5 mg QD	0.178
Alogliptin 25 mg QD	0.348

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).

Intervention	mg/dL (Least Squares Mean)
Placebo	6.3
Alogliptin 12.5 mg QD	-5.0
Alogliptin 25 mg QD	-9.9

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).

Intervention	mg/dL (Least Squares Mean)
Placebo	-1.4
Alogliptin 12.5 mg QD	-5.2
Alogliptin 25 mg QD	-2.9

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).

Intervention	mg/dL (Least Squares Mean)
Placebo	4.6
Alogliptin 12.5 mg QD	-5.3
Alogliptin 25 mg QD	-6.3

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).

Intervention	mg/dL (Least Squares Mean)
Placebo	1.0
Alogliptin 12.5 mg QD	-3.1
Alogliptin 25 mg QD	-11.4

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).

Intervention	mg/dL (Least Squares Mean)
Placebo	8.6
Alogliptin 12.5 mg QD	-4.2
Alogliptin 25 mg QD	-11.3

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).

Intervention	mg/dL (Least Squares Mean)
Placebo	5.8
Alogliptin 12.5 mg QD	2.3
Alogliptin 25 mg QD	-11.7

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).

Intervention	mg/dL (Least Squares Mean)
Placebo	5.3
Alogliptin 12.5 mg QD	-5.0
Alogliptin 25 mg QD	-12.1

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.

Intervention	mg/dL (Least Squares Mean)
Placebo	5.4
Alogliptin 12.5 mg QD	-13.5
Alogliptin 25 mg QD	-14.1

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. (NCT00286429)
Timeframe: Baseline and Week 26.

Change From Baseline in Glycosylated Hemoglobin (Week 12).

Intervention	percentage of Glycosylated Hemoglobin (Least Squares Mean)
Placebo	-0.13
Alogliptin 12.5 mg QD	-0.63
Alogliptin 25 mg QD	-0.71

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. (NCT00286429)
Timeframe: Baseline and Week 12.

Change From Baseline in Glycosylated Hemoglobin (Week 16).

Intervention	percentage of Glycosylated Hemoglobin (Least Squares Mean)
Placebo	-0.27
Alogliptin 12.5 mg QD	-0.84
Alogliptin 25 mg QD	-0.81

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. (NCT00286429)
Timeframe: Baseline and Week 16.

Change From Baseline in Glycosylated Hemoglobin (Week 20).

Intervention	percentage of Glycosylated Hemoglobin (Least Squares Mean)
Placebo	-0.22
Alogliptin 12.5 mg QD	-0.80
Alogliptin 25 mg QD	-0.76

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. (NCT00286429)
Timeframe: Baseline and Week 20.

Change From Baseline in Glycosylated Hemoglobin (Week 4).

Intervention	percentage of Glycosylated Hemoglobin (Least Squares Mean)
Placebo	-0.17
Alogliptin 12.5 mg QD	-0.76
Alogliptin 25 mg QD	-0.74

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. (NCT00286429)
Timeframe: Baseline and Week 4.

Change From Baseline in Glycosylated Hemoglobin (Week 8).

Intervention	percentage of Glycosylated Hemoglobin (Least Squares Mean)
Placebo	-0.26
Alogliptin 12.5 mg QD	-0.47
Alogliptin 25 mg QD	-0.58

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. (NCT00286429)
Timeframe: Baseline and Week 8.

Number of Participants Requiring Rescue.

Intervention	percentage of Glycosylated Hemoglobin (Least Squares Mean)
Placebo	-0.27
Alogliptin 12.5 mg QD	-0.76
Alogliptin 25 mg QD	-0.84

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%.

Intervention	participants (Number)
Placebo	52
Alogliptin 12.5 mg QD	27
Alogliptin 25 mg QD	25

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. (NCT00286429)
Timeframe: Baseline and Week 26.

Number of Participants With Glycosylated Hemoglobin ≤ 7.0%.

Intervention	participants (Number)
Placebo	0
Alogliptin 12.5 mg QD	3
Alogliptin 25 mg QD	3

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. (NCT00286429)
Timeframe: Baseline and Week 26.

Number of Participants With Glycosylated Hemoglobin ≤ 7.5%.

Intervention	participants (Number)
Placebo	1
Alogliptin 12.5 mg QD	11
Alogliptin 25 mg QD	10

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. (NCT00286429)
Timeframe: Baseline and Week 26.

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

Intervention	participants (Number)
Placebo	5
Alogliptin 12.5 mg QD	22
Alogliptin 25 mg QD	33

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. (NCT00286429)
Timeframe: Baseline and Week 26.

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

Intervention	participants (Number)
Placebo	40
Alogliptin 12.5 mg QD	70
Alogliptin 25 mg QD	70

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%.

Intervention	participants (Number)
Placebo	17
Alogliptin 12.5 mg QD	41
Alogliptin 25 mg QD	47

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%.

Intervention	participants (Number)
Placebo	6
Alogliptin 12.5 mg QD	22
Alogliptin 25 mg QD	23

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).

Intervention	participants (Number)
Placebo	0
Alogliptin 12.5 mg QD	11
Alogliptin 25 mg QD	11

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.

Article	Year
Alogliptin versus glipizide monotherapy in elderly type 2 diabetes mellitus patients with mild hyperglycaemia: a prospective, double-blind, randomized, 1-year study. Diabetes, obesity & metabolism, 2013, Volume: 15, Issue:10 Topics: Aged; Aged, 80 and over; Blood Glucose; Diabetes Mellitus, Type 2; Dipeptidyl-Peptidase IV Inhibitor	2013
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. Expert opinion on pharmacotherapy, 2014, Volume: 15, Issue:15 Topics: Aged; Blood Glucose; Diabetes Mellitus, Type 2; Double-Blind Method; Drug Therapy, Combination; Fema	2014
Comparison of alogliptin and glipizide for composite endpoint of glycated haemoglobin reduction, no hypoglycaemia and no weight gain in type 2 diabetes mellitus. Diabetes, obesity & metabolism, 2016, Volume: 18, Issue:6 Topics: Adult; Aged; Aged, 80 and over; Blood Glucose; Diabetes Mellitus, Type 2; Double-Blind Method; Drug	2016
Alogliptin added to insulin therapy in patients with type 2 diabetes reduces HbA(1C) without causing weight gain or increased hypoglycaemia. Diabetes, obesity & metabolism, 2009, Volume: 11, Issue:12 Topics: Adolescent; Adult; Aged; Aged, 80 and over; Blood Glucose; Diabetes Mellitus, Type 2; Double-Blind M	2009
Effect of additional administration of acarbose on blood glucose fluctuations and postprandial hyperglycemia in patients with type 2 diabetes mellitus under treatment with alogliptin. Endocrine journal, 2013, Volume: 60, Issue:4 Topics: Acarbose; Blood Glucose; Body Mass Index; Diabetes Mellitus, Type 2; Dipeptidyl-Peptidase IV Inhibit	2013

Article	Year
Body weight changes in patients with type 2 diabetes and a recent acute coronary syndrome: an analysis from the EXAMINE trial. Cardiovascular diabetology, 2021, 09-14, Volume: 20, Issue:1 Topics: Acute Coronary Syndrome; Aged; Body Mass Index; Comorbidity; Diabetes Mellitus, Type 2; Dipeptidyl-P	2021
Liver mitochondrial cristae organizing protein MIC19 promotes energy expenditure and pedestrian locomotion by altering nucleotide metabolism. Cell metabolism, 2023, 08-08, Volume: 35, Issue:8 Topics: Animals; Diet, High-Fat; Energy Metabolism; Liver; Mice; Mitochondria, Liver; Mitochondrial Proteins	2023
Nicotinamide supplementation induces detrimental metabolic and epigenetic changes in developing rats. The British journal of nutrition, 2013, Volume: 110, Issue:12 Topics: Animals; Betaine; Choline; CpG Islands; Dietary Supplements; DNA; DNA Damage; DNA Methylation; Epige	2013
Treatment of streptozotocin-induced diabetic rats with alogliptin: effect on vascular and neural complications. Experimental diabetes research, 2011, Volume: 2011 Topics: Animals; Blood Glucose; Diabetes Mellitus, Experimental; Diabetes Mellitus, Type 1; Diabetic Angiopa	2011
[Effect of purine-rich nutrients on weight gain, catabolites in blood plasma and the uric acid transport of erythrocytes--a model study in dogs]. Zeitschrift fur Ernahrungswissenschaft, 1990, Volume: 29, Issue:2 Topics: Allantoin; Animals; Biological Transport, Active; Dogs; Erythrocytes; Female; Purines; Uracil; Uric	1990

uracil and Weight Gain