Compounds > glipizide
Page last updated: 2024-10-28

glipizide and Body Weight

glipizide has been researched along with Body Weight in 23 studies

Glipizide: An oral hypoglycemic agent which is rapidly absorbed and completely metabolized.
glipizide : An N-sulfonylurea that is glyburide in which the (5-chloro-2-methoxybenzoyl group is replaced by a (5-methylpyrazin-2-yl)carbonyl group. An oral hypoglycemic agent, it is used in the treatment of type 2 diabetes mellitus.

Body Weight: The mass or quantity of heaviness of an individual. It is expressed by units of pounds or kilograms.

Research Excerpts

ExcerptRelevanceReference
"In patients completing 4 years of treatment, dapagliflozin was well tolerated and associated with sustained glycaemic efficacy and greater reductions in body weight and SBP versus glipizide."5.20Long-term glycaemic response and tolerability of dapagliflozin versus a sulphonylurea as add-on therapy to metformin in patients with type 2 diabetes: 4-year data. ( Del Prato, S; Durán-Garcia, S; Maffei, L; Nauck, M; Parikh, S; Rohwedder, K; Theuerkauf, A, 2015)
"A retrospective analysis was conducted to determine the effects of metformin on glycosylated hemoglobin (HbA1c), body weight, and adverse events in an African-American population."3.69A retrospective analysis of the efficacy and safety of metformin in the African-American patient. ( Anderson, D; Briscoe, TA; Cooper, GS; Usifo, OS, 1997)
" Adverse events (AE) and hypoglycemia were monitored."2.79Saxagliptin efficacy and safety in patients with type 2 diabetes mellitus stratified by cardiovascular disease history and cardiovascular risk factors: analysis of 3 clinical trials. ( Bryzinski, B; Cook, W; Hirshberg, B; Minervini, G, 2014)
" There was a lower incidence of symptomatic hypoglycemia adverse events (AEs) with sitagliptin versus glipizide (6."2.78Efficacy and safety of sitagliptin versus glipizide in patients with type 2 diabetes and moderate-to-severe chronic renal insufficiency. ( Arjona Ferreira, JC; Barzilai, N; Goldstein, BJ; Golm, GT; Guo, H; Kaufman, KD; Marre, M; Sisk, CM, 2013)
"Glipizide or placebo was added (randomized) at Week 15 if the fasting plasma glucose level in patients exceeded 115 mg/dl."2.66Achieving therapeutic goals in insulin-using diabetic patients with non-insulin-dependent diabetes mellitus. A weight reduction-exercise-oral agent approach. ( Carroll-Michals, L; Darga, LL; Kasim, S; Kinhal, V; Lucas, CP; Patton, S; Spafford, TR; Stepke, T, 1987)
") and in Study 2 (n = 12) the comparison was between intake once-daily before breakfast and dosing before breakfast, lunch, and at bedtime (10 p."2.66Therapeutic equivalence of once- and thrice-daily glipizide. ( Groop, L; Groop, PH; Karhumaa, S; Melander, A; Tötterman, KJ; Wåhlin-Boll, E, 1986)
" Post-dose glipizide concentrations were three times higher than those of glibenclamide, due to the incomplete bioavailability of the latter."2.66Pharmacokinetics and metabolic effects of glibenclamide and glipizide in type 2 diabetics. ( Fyhrqvist, F; Groop, L; Groop, PH; Melander, A; Tolppanen, EM; Tötterman, KJ; Wåhlin-Boll, E, 1985)
" Mean initial dosage was 7."2.64Glipizide in the treatment of maturity-onset diabetes: a multi-centre, out-patient study. ( Fowler, LK, 1978)
" Aqueous extract of Annona squamosa was administered orally at 350 mg/kg body weight alone and in combination with reduced and reducing dose combinations of Glipizide."1.39Polypharmacy (herbal and synthetic drug combination): a novel approach in the treatment of type-2 diabetes and its complications in rats. ( Afzal, M; Ahamd, I; Ahmad, S; Ahmed, Z; Ali, B; Anwar, F; Kaur, R; Kazmi, I, 2013)
"Hypoglycemia was defined as blood glucose (BG) concentration < 60 mg/dl."1.30Prospective multicenter study of sulfonylurea ingestion in children. ( Anderson, BD; Anderson, DL; Fenn, J; Gorman, SE; Krenzelok, EP; Muir, SJ; Rodgers, GC; Rose, SR; Spiller, HA; Villalobos, D, 1997)
"Ten Type 2 diabetics were examined during long-term treatment, at two dosage levels, with chlorpropamide once daily and glipizide t."1.26Impaired effect of sulfonylurea following increased dosage. ( Melander, A; Sartor, G; Scherstén, B; Wåhlin-Boll, E, 1982)

Research

Studies (23)

TimeframeStudies, this research(%)All Research%
pre-199011 (47.83)18.7374
1990's4 (17.39)18.2507
2000's2 (8.70)29.6817
2010's6 (26.09)24.3611
2020's0 (0.00)2.80

Authors

AuthorsStudies
Nauck, M2
del Prato, S3
Meier, JJ1
Durán-García, S3
Rohwedder, K3
Elze, M1
Parikh, SJ2
Nauck, MA1
Langkilde, AM1
Sugg, J1
Cook, W1
Minervini, G1
Bryzinski, B1
Hirshberg, B1
Maffei, L1
Theuerkauf, A1
Parikh, S1
Kaur, R1
Afzal, M1
Kazmi, I1
Ahamd, I1
Ahmed, Z1
Ali, B1
Ahmad, S1
Anwar, F1
Arjona Ferreira, JC1
Marre, M1
Barzilai, N1
Guo, H1
Golm, GT1
Sisk, CM1
Kaufman, KD1
Goldstein, BJ1
Halperin, F1
Ingelfinger, JR1
McMahon, GT1
Lebovitz, HE2
Feinglos, MN1
Wåhlin-Boll, E5
Sartor, G2
Melander, A5
Scherstén, B2
Nelson, RW1
Feldman, EC1
Ford, SL1
Roemer, OP1
Spiller, HA1
Villalobos, D1
Krenzelok, EP1
Anderson, BD1
Gorman, SE1
Rose, SR1
Fenn, J1
Anderson, DL1
Muir, SJ1
Rodgers, GC1
Briscoe, TA1
Anderson, D1
Usifo, OS1
Cooper, GS1
Martin, G1
Rand, J1
Fowler, LK1
Bitzén, PO1
Svensson, M1
Rosenstock, J1
Meisel, A1
Raskin, P1
Lucas, CP1
Patton, S1
Stepke, T1
Kinhal, V1
Darga, LL1
Carroll-Michals, L1
Spafford, TR1
Kasim, S1
Ursing, D1
Nilsson-Ehle, P1
Groop, L2
Karhumaa, S1
Groop, PH2
Tötterman, KJ2
Liu, GC1
Coulston, AM1
Lardinois, CK1
Hollenbeck, CB1
Moore, JG1
Reaven, GM1
Gerich, JE1
Tolppanen, EM1
Fyhrqvist, F1

Clinical Trials (8)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
A 52-Week International, Multi-centre, Randomised, Parallel-group, Double-blind, Active-controlled, Phase III Study With a 156-Week Extension Period to Evaluate the Efficacy and Safety of Dapagliflozin in Combination With Metformin Compared With Sulphonyl[NCT00660907]Phase 31,217 participants (Actual)Interventional2008-03-31Completed
A Study of the Effects of Dapagliflozin on Ambulatory Aortic Pressure, Arterial Stiffness and Urine Albumin Excretion in Patients With Type 2 Diabetes[NCT02887677]Phase 485 participants (Actual)Interventional2016-10-31Terminated (stopped due to On February 2019 Astra-Zeneca Greece decided to stop the financial support of the study.)
Effectiveness of the Treatment With Dapagliflozin and Metformin Compared to Metformin Monotherapy for Weight Loss on Diabetic and Prediabetic Patients With Obesity Class III[NCT03968224]Phase 2/Phase 390 participants (Anticipated)Interventional2018-07-07Recruiting
A Multicenter, Randomized, Double-Blind, Phase 3 Trial to Evaluate the Efficacy and Safety of Saxagliptin Added to Insulin Monotherapy or to Insulin in Combination With Metformin in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Ins[NCT00757588]Phase 3455 participants (Actual)Interventional2008-11-30Completed
A 52-Week International, Multi-centre, Randomized, Parallel-group, Double-blind, Active-controlled, Phase III Study With a 52-Week Extension Period to Evaluate the Safety and Efficacy of Saxagliptin in Combination With Metformin Compared With Sulphonylure[NCT00575588]Phase 3891 participants (Actual)Interventional2007-12-31Completed
A Multicenter, Randomized, Double-Blind Active-Controlled, Phase 3 Trial to Evaluate the Efficacy and Safety of Saxagliptin in Combination With Metformin IR as Initial Therapy Compared to Saxagliptin Monotherapy and to Metformin IR Monotherapy in Subjects[NCT00327015]Phase 31,306 participants (Actual)Interventional2006-05-31Completed
Prospective, Parallel Goups Study, Aimed to Evaluating Possible Benefits of the Treatment of New Generation Hypoglycaemic Drugs Compared to Sulphonylureas for the Tratment of Type 2 Diabetes Mellitus[NCT04272359]138 participants (Anticipated)Observational [Patient Registry]2019-05-06Recruiting
A Multicenter, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Sitagliptin Versus Glipizide in Patients With Type 2 Diabetes Mellitus and Chronic Renal Insufficiency Who Have Inadequate Glycemic Control[NCT00509262]Phase 3426 participants (Actual)Interventional2007-10-09Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

Adjusted Mean Change in Body Weight

To assess the effect of dapagliflozin plus metformin compared to glipizide plus metformin on body weight after 52 weeks double-blind treatment. (NCT00660907)
Timeframe: Baseline to Week 52

Interventionkg (Least Squares Mean)
Dapagliflozin Plus Metformin-3.22
Glipizide Plus Metformin1.44

Adjusted Mean Change in HbA1c Levels

To assess the effect of dapagliflozin plus metformin compared to glipizide plus metformin on the absolute change from baseline in HbA1c level after 52 weeks double-blind treatment in patients with type 2 diabetes who have inadequate glycaemic control on 1500 mg/day or higher doses of metformin therapy alone. (NCT00660907)
Timeframe: Baseline to Week 52

Interventionpercent (Least Squares Mean)
Dapagliflozin Plus Metformin-0.52
Glipizide Plus Metformin-0.52

Proportion of Participants With at Least One Episode of Hypoglycemia

To assess the effect of dapagliflozin plus metformin treatment compared to glipizide plus metformin on the occurrence of hypoglycemic events. Least Squares Mean represents the percent of participants adjusted for HbA1c baseline value. (NCT00660907)
Timeframe: Baseline to Week 52

InterventionPercentage of participants (Least Squares Mean)
Dapagliflozin Plus Metformin3.5
Glipizide Plus Metformin40.8

Proportion of Participants With Body Weight Reduction of at Least 5%

To evaluate the effect of dapagliflozin plus metformin compared to glipizide plus metformin on body weight assessed by a reduction after 52 weeks of at least 5% compared to baseline. Least Squares Mean represents the percent of participants adjusted for baseline value. (NCT00660907)
Timeframe: Baseline to Week 52

InterventionPercentage of participants (Least Squares Mean)
Dapagliflozin Plus Metformin33.3
Glipizide Plus Metformin2.5

Adjusted Mean Change From Baseline in A1C Levels (Last Observation Carried Forward [LOCF])

Change from baseline: post-pre. Adjusted for baseline (value and metformin use). ANCOVA model: difference between week t and baseline values=baseline values + treatment + metformin use (NCT00757588)
Timeframe: Baseline to Week 24

InterventionPercentage of change (Mean)
Saxagliptin, 5 mg + Insulin-0.73
Placebo + Insulin-0.32

Change From Baseline in 120-minute PPG Values During an MTT

An MTT is a 2-part test that measures glucose and insulin levels after an overnight fast and before ingesting a meal consisting of a nutritional drink and power bar and again at prespecified times (30, 60, 120, and 180 minutes) after the start of ingestion of the meal. (NCT00757588)
Timeframe: Baseline to Week 24

Interventionmg/dL (Mean)
Saxagliptin, 5 mg + Insulin-27.2
Placebo + Insulin-4.2

Change From Baseline in Fasting Plasma Glucose Values

(NCT00757588)
Timeframe: Baseline to Week 24

Interventionmg/dL (Mean)
Saxagliptin, 5 mg + Insulin-10.1
Placebo + Insulin-6.1

Change From Baseline in Mean Total Daily Dose of Insulin (MTDDI) (LOCF)

Based on information recorded in the participant's daily diary. The MTDDI was calculated at every visit using the values patients recorded since the last regularly scheduled visit (minimum of 80% of days with a value). At every visit, the MTDDI was compared with the participant's baseline MTDDI (measured during a 4-week lead-in period) to identify any changes in insulin use at that visit compared with insulin use at baseline. (NCT00757588)
Timeframe: Baseline to Week 24

InterventionUnits (Mean)
Saxagliptin, 5 mg + Insulin1.71
Placebo + Insulin5.01

Change From Baseline in Postprandial Glucose (PPG) Area Under the Curve (AUC) Response to an Meal Tolerance Test (MTT)

An MTT is a 2-part test that measures glucose and insulin levels after an overnight fast and before ingesting a meal consisting of a nutritional drink and power bar and again at prespecified times (30, 60, 120, and 180 minutes) after the start of ingestion of the meal (NCT00757588)
Timeframe: Baseline to Week 24

Interventionmg*min/dL (Mean)
Saxagliptin, 5 mg + Insulin-4548.5
Placebo + Insulin-718.8

Number of Participants With Abnormal Changes From Baseline in Electrocardiogram (ECG) Results

"ECG abnormalities included those in nonspecific other categories (Other nonspecific ST/T, Other intraventricular conduction defect, Other, and Other rhythm abnormalities)and nonspecific findings, such as sinus bradycardia, sinus arrythmia, sinus tachycardia, poor R-wave progression, and ventricular premature contractions." (NCT00757588)
Timeframe: Baseline to Week 52

InterventionParticipants (Number)
Saxagliptin, 5 mg + Insulin15
Placebo + Insulin11

Percentage of Participants Achieving a Therapeutic Glycemic Response

Therapeutic glycemic response is defined as an A1C<7%. Significance was not interpreted with a p value. (NCT00757588)
Timeframe: Baseline to Week 24

InterventionPercentage of participants (Number)
Saxagliptin, 5 mg + Insulin17.3
Placebo + Insulin6.7

Mean Changes From Baseline in Heart Rate

(NCT00757588)
Timeframe: Baseline to Weeks 2, 4, 6, 8, 12, 16, 20, 24, 28, 36, 44, and 52

,
InterventionBeats per minute (Number)
Week 2 (n=294, 147)Week 4 (n=293, 144)Week 6 (n=280, 141)Week 8 (n=290, 142)Week 12 (n=286, 144)Week 16 (n=278, 139)Week 20 (n=276, 137)Week 24 (n=273, 134)Week 28 (n=264, 132)Week 36 (n=261, 129)Week 44 (n=250, 125)Week 52 (n=246, 125)
Placebo + Insulin-0.7-1.0-0.9-0.70.2-0.60.4-1.0-0.6-0.0-0.70.2
Saxagliptin, 5 mg + Insulin-0.5-0.5-0.5-0.00.3-1.0-0.50.0-1.00.00.2-0.3

Mean Changes From Baseline in Systolic and Diastolic Blood Pressure Readings

(NCT00757588)
Timeframe: Baseline to Weeks 2, 4, 6, 8, 12, 16, 20, 24, 28, 36, 44, and 52

,
Interventionmm Hg (Number)
Systolic blood pressure (Week 2) (n=294, 147)Systolic blood pressure (Week 4) (n=293, 144)Systolic blood pressure (Week 6) (n=280, 141)Systolic blood pressure (Week 8) (n=290, 142)Systolic blood pressure (Week 12) (n=286, 144)Systolic blood pressure (Week 16) (n=278, 139)Systolic blood pressure (Week 20) (n=276, 137)Systolic blood pressure (Week 24) (n=273, 134)Systolic blood pressure (Week 28) (n=264, 132)Systolic blood pressure (Week 36) (n=261, 129)Systolic blood pressure (Week 44) (n=250, 125)Systolic blood pressure (Week 52) (n=246, 125)Diastolic blood pressure (Week 2) (n=294, 147)Diastolic blood pressure (Week 4) (n=293, 144)Diastolic blood pressure (Week 6) (n=280, 141)Diastolic blood pressure (Week 8) (n=290, 142)Diastolic blood pressure (Week 12) (n=286, 144)Diastolic blood pressure (Week 16) (n=278, 139)Diastolic blood pressure (Week 20) (n=276, 137)Diastolic blood pressure (Week 24) (n=273, 134)Diastolic blood pressure (Week 28) (n=264, 132)Diastolic blood pressure (Week 36) (n=261, 129)Diastolic blood pressure (Week 44) (n=250, 125)Diastolic blood pressure (Week 52) (n=246, 125)
Placebo + Insulin2.30.01.02.42.21.11.3-0.11.83.62.61.01.41.80.32.11.01.31.10.50.20.20.40.1
Saxagliptin, 5 mg + Insulin-1.0-1.2-0.8-0.8-1.7-1.2-0.6-1.5-1.4-0.7-0.60.00.10.00.0-0.5-0.8-1.1-0.7-1.7-1.6-1.2-0.3-0.5

Number of Participants With at Least 1 Adverse Event (AE), at Least 1 Treatment-related AE, Death as Outcome, at Least 1 Serious Adverse Event (SAE), at Least 1 Treatment-related SAE, Discontinuations Due to SAEs, and Discontinuations Due to AEs

An AE is any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical event that at any dose: results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; requires inpatient hospitalization; or prolongs existing hospitalization. Treatment-related=possibly, probably, or certainly related to and of unknown relationship to study treatment. (NCT00757588)
Timeframe: Baseline to Week 52, continuously

,
InterventionParticipants (Number)
At least 1 AEAt least 1 treatment-related AEDeathsAt least 1 SAEAt least 1 treatment-related SAEDiscontinuations due to SAEsDiscontinuations due to AEs
Placebo + Insulin10834013003
Saxagliptin, 5 mg + Insulin20256225349

Number of Participants With Marked Laboratory Abnormalities During the 24-Week ST + 52-Week LT Treatment Period

"Marked abnormality=a laboratory value lying outside the predefined criteria and more extreme (farther from the limit)on-treatment than at baseline. ULN=upper limit of normal; LLN=lower limit of normal; prx=pre-RX=pretreatment.~Criteria 1: if prx=0 use >=2, if prx=0.5 or 1 use >=3, if prx=2 use 4." (NCT00757588)
Timeframe: Baseline and during and up to 14 days after last dose of study drug (in Week 52)

,
InterventionParticipants (Number)
Hemoglobin <8 g/dL (n=300; 150)Hematocrit <0.75*prx (n=300; 150)Platelets <50*10^9 c/L (n=297; 145)Platelets >1.5*ULN (n=297; 145)Leukocytes <2*1000 c/uL (n=300; 150)Neutrophils <1*1000 c/uL (n=296; 150)Eosinophils >0.9*1000 c/uL (n=296; 150)Lymphocytes <=0.75*1000 c/uL (n=296; 150)Alkaline phosphatase >3*prx & >ULN (n=302; 150)Alkaline phosphatase >1.5 ULN (n=302; 150)Aspartate aminotransferase >3* ULN (n=298; 148)Aspartate aminotransferase>5* ULN (n=298; 148)Aspartate aminotransferase >10*ULN (n=298; 148)Aspartate aminotransferase >20*ULN (n=298; 148)Alanine transaminase >3*ULN (n=300; 148)Alanine transaminase >5*ULN (n=300; 148)Alanine transaminase >10*ULN (n=300; 148)Alanine transaminase >20*ULN (n=300; 148)Bilirubin, total >2 mg/dL (n=301; 150)Bilirubin, total >1.5*ULN (n=301; 150)Bilirubin, total >2*ULN (n=301; 150)Blood urea nitrogen >2*prx & >ULN (n=302; 150)Creatinine >2.5 mg/dL (n=303; 150)Glucose, serum fasting <50 mg/dL (n=0; 0)Glucose, serum fasting >500 mg/dL (n=0; 0)Glucose, serum unspecified <50 mg/dL (n=0; 0)Glucose, serum unspecified >500 mg/dL (n=0; 0)Glucose, plasma fasting <50 mg/dL (n=301;150)Glucose, plasma fasting >500 mg/dL (n=301;150)Glucose, plasma unspecified <50 mg/dL (n=272; 133)Glucose, plasma unspecified >500 mg/d (n=272; 133)Sodium, serum <0.9*prx & <=130 mEq/L (n=302; 150)Sodium, serum >1.1*prx & >=150 mEq/L (n=302; 150)Potassium, serum <0.8 prx &<=3.2 mEq/L(n=300; 148)Potassium, serum >1.2*prx&>= 6.0 mEq/L(n=300; 148)Chloride, serum <90 mEq/L (n=302; 150)Chloride, serum >120 mEq/L (n=302; 150)Albumin <0.9*LLN; if prxCreatine kinase >5*ULN (n=301, 148)Uric acid >1.5*ULN; if prx >ULN, >2 (n=0,0)Protein urine (see criteria 1) (n=297,146)Blood urine (see criteria 1) (n=297; 146)Red blood cells urine (see criteria 1) (n=53; 31)White blood cells urine (see criteria 1)(n=115;53)
Placebo + Insulin020010721500003000010700000011100180002032310
Saxagliptin, 5 mg + Insulin22000193210210051000005000005051103810160814835

Percentage of Participants With Reported and Confirmed Hypoglycemia

Confirmed hypoglycemia=fingerstick glucose measurement of ≤50 mg/dL with associated symptoms/ (NCT00757588)
Timeframe: Baseline to Week 52

,
InterventionPercentage of Participants (Number)
ReportedConfirmed
Placebo + Insulin24.56.6
Saxagliptin, 5 mg + Insulin19.47.6

Shift in Absolute Lymphocyte Counts From Baseline to Selected Visits (LOCF)

Absolute lymphocyte count=value*10^3 c/uL (NCT00757588)
Timeframe: Baseline and Weeks 24 and 52

,
InterventionParticipants (Number)
Baseline <= 0.75; Week 24 <= 0.75Baseline <= 0.75; Week 24 >0.75- <= 5.00Baseline <= 0.75; Week 24 >5.00Baseline >0.75- <= 5.00; Week 24 <= 0.75Baseline >0.75- <= 5.00; Week 24 >0.75- <= 5.00Baseline >0.75- <= 5.00; Week 24 >5.00Baseline >5.00; Week 24 <= 0.75Baseline >5.00; Week 24 >0.75- <= 5.00Baseline >5.00; Week 24 >5.00Baseline <= 0.75; Week 52 <= 0.75Baseline <= 0.75; Week 52 >0.75- <= 5.00Baseline <= 0.75; Week 52 >5.00Baseline >0.75- <= 5.00; Week 52 <= 0.75Baseline >0.75- <= 5.00; Week 52 >0.75- <= 5.00Baseline >0.75- <= 5.00; Week 52 >5.00Baseline >5.00; Week 52 <= 0.75Baseline >5.00; Week 52 >0.75- <= 5.00Baseline >5.00; Week 52 >5.00
Placebo + Insulin0200148000002001471000
Saxagliptin, 5 mg + Insulin0001293100100002950001

Shift in Platelet Counts From Baseline to Selected Visits (LOCF)

Platelet count=value*10^9 c/L (NCT00757588)
Timeframe: Baseline and Weeks 24 and 52

,
InterventionParticipants (Number)
Baseline <= 100; Week 24 <= 100Baseline <= 100; Week 24 >100 - <= 600Baseline <= 100; Week 24 >600Baseline >100 - <= 600; Week 24 <= 100Baseline >100 - <= 600; Week 24 >100 - <= 600Baseline >100 - <= 600; Week 24 >600Baseline >600; Week 24 <= 100Baseline >600; Week 24 >100 - <= 600Baseline >600; Week 24 >600Baseline <= 100; Week 52 <= 100Baseline <= 100; Week 52 >100 - <= 600Baseline <= 100; Week 52 >600Baseline >100 - <= 600; Week 52 <= 100Baseline >100 - <= 600; Week 52 >100 - <= 600Baseline >100 - <= 600; Week 52 >600Baseline >600; Week 52 <= 100Baseline >600; Week 52 >100 - <= 600Baseline >600; Week 52 >600
Placebo + Insulin0001143000001001440000
Saxagliptin, 5 mg + Insulin0001296000000022950000

Mean Slope of the Regressions of Change From Week 24 to Week 104 in HbA1c

Mean slopes of regression of change from Week 24 to Week 104 in HbA1c for saxagliptin added on to metformin versus glipizide added on to metformin (Full Analysis Set) achieved by fitting a mixed model with subject specific slopes for the time effect (weeks on randomized treatment was utilized). This analysis gives an assessment of the durability of the HbA1c effect. (NCT00575588)
Timeframe: Week 24 to Week 104

InterventionPercent (Mean)
Saxagliptin + Metformin0.0041
Glipizide + Metformin0.0076

Mean Slope of the Regressions of Change From Week 24 to Week 52 in HbA1c

Mean slopes of regression of change from Week 24 to Week 52 in HbA1c for saxagliptin added on to metformin versus glipizide added on to metformin (Per Protocol Analysis Set) achieved by fitting a mixed model with subject specific slopes for the time effect (weeks on randomized treatment was utilized). This analysis gives an assessment of the durability of the HbA1c effect. (NCT00575588)
Timeframe: Week 24 to Week 52

InterventionPercent (Mean)
Saxagliptin + Metformin0.001
Glipizide + Metformin0.004

Proportion of Participants Reporting at Least One Episode of Any Hypoglycaemic Event Over 104 Weeks

Proportion of participants reporting at least one episode of any hypoglycaemic event for saxagliptin added on to metformin versus glipizide added on to metformin over 104 weeks (Safety Analysis Set) (NCT00575588)
Timeframe: Baseline, Week 104

InterventionPercentage of Participants (Number)
Saxagliptin + Metformin3.5
Glipizide + Metformin38.4

Proportion of Participants Reporting at Least One Episode of Any Hypoglycaemic Event Over 52 Weeks

Proportion of participants reporting at least one episode of any hypoglycaemic event for saxagliptin added on to metformin versus glipizide added on to metformin over 52 weeks (Safety Analysis Set) (NCT00575588)
Timeframe: From Baseline to Week 52

InterventionPercentage of Participants (Number)
Saxagliptin + Metformin3
Glipizide + Metformin36.3

Body Weight Change From Baseline to Week 104

Adjusted mean change from baseline in Body Weight achieved with saxagliptin added on to metformin versus glipizide added on to metformin at Week 104. Body Weight is a continuous measure, the change from baseline for each participant is calculated as the Week 104 value minus the baseline value. (NCT00575588)
Timeframe: Baseline, Week 104

,
Interventionkilograms (Mean)
BaselineWeek 104Adjusted Change from Baseline to Week 104
Glipizide + Metformin88.5789.801.29
Saxagliptin + Metformin88.6987.47-1.47

Body Weight Change From Baseline to Week 52

Adjusted mean change from baseline in Body Weight achieved with saxagliptin added on to metformin versus glipizide added on to metformin at Week 52 (Safety Analysis Set). Body Weight is a continuous measure, the change from baseline for each participant is calculated as the Week 52 (LOCF) value minus the baseline value. (NCT00575588)
Timeframe: Baseline, Week 52 (Last Observation Carried Forward)

,
Interventionkilogram (Mean)
BaselineWeek 52Adjusted Change from Baseline to Week 52
Glipizide + Metformin88.689.71.1
Saxagliptin + Metformin88.787.6-1.1

Hemoglobin A1c (HbA1c) Change From Baseline to Week 104

Adjusted mean change from baseline in HbA1c achieved with saxagliptin added on to metformin versus glipizide added on to metformin at Week 104 (Full Analysis Set). HbA1c is a continuous measure, the change from baseline for each participant is calculated as the Week 104 value minus the baseline value. (NCT00575588)
Timeframe: Baseline, Week 104

,
InterventionPercent (Mean)
BaselineWeek 104Adjusted Change from Baseline to Week 104
Glipizide + Metformin7.657.27-0.35
Saxagliptin + Metformin7.657.27-0.41

Hemoglobin A1c (HbA1c) Change From Baseline to Week 52

Adjusted mean change from baseline in HbA1c achieved with saxagliptin added on to metformin versus glipizide added on to metformin at Week 52 (Per Protocol Analysis Set). HbA1c is a continuous measure, the change from baseline for each participant is calculated as the Week 52 value minus the baseline value. (NCT00575588)
Timeframe: Baseline to 52 Weeks

,
InterventionPercent (Mean)
BaselineWeek 52Adjusted Change from Baseline to Week 52
Glipizide + Metformin7.536.71-0.80
Saxagliptin + Metformin7.466.74-0.74

Percentage of Participants Achieving A1C < 7% at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy

Percentage of participants achieving A1C < 7%, the American Diabetes Association's defined goal for glycemia, at each dose of saxagliptin plus metformin versus metformin alone at Week 24. (NCT00327015)
Timeframe: Week 24

InterventionPercentage of participants (Number)
Saxagliptin 5 mg + Metformin60.3
Saxagliptin 10 mg + Metformin59.7
Metformin41.1

Percentage of Participants Achieving A1C < 7% at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy

Percentage of participants achieving A1C < 7%, the American Diabetes Association's defined goal for glycemia, at each dose of saxagliptin plus metformin versus saxagliptin alone at Week 24. (NCT00327015)
Timeframe: Week 24

InterventionPercentage of participants (Number)
Saxagliptin 5 mg + Metformin60.3
Saxagliptin 10 mg + Metformin59.7
Saxagliptin 10 mg32.2

Percentage of Participants Achieving A1C ≤6.5% at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy

Percentage of participants achieving A1C ≤6.5%, at each dose of saxagliptin plus metformin versus metformin alone at Week 24. (NCT00327015)
Timeframe: Week 24

InterventionPercentage of participants (Number)
Saxagliptin 5 mg + Metformin45.3
Saxagliptin 10 mg + Metformin40.6
Metformin29.0

Percentage of Participants Achieving A1C ≤6.5% at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy

Percentage of participants achieving A1C ≤6.5%, at each dose of saxagliptin plus metformin versus saxagliptin alone at Week 24. (NCT00327015)
Timeframe: Week 24

InterventionPercentage of Participants (Number)
Saxagliptin 5 mg + Metformin45.3
Saxagliptin 10 mg + Metformin40.6
Saxagliptin 10 mg20.3

Percentage of Participants Requiring Rescue or Discontinuation at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy

Percentage of participants requiring rescue for failing to achieve pre-specified glycemic targets or discontinuing for lack of efficacy within the 24-week treatment period at each dose of saxagliptin plus metformin versus metformin alone. (NCT00327015)
Timeframe: Week 24

InterventionPercentage of participants (Number)
Saxagliptin 5 mg + Metformin7.5
Saxagliptin 10 mg + Metformin5.9
Metformin10.1

Percentage of Participants Requiring Rescue or Discontinuation at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy

Percentage of participants requiring rescue for failing to achieve pre-specified glycemic targets or discontinuing for lack of efficacy within the 24-week treatment period at each dose of saxagliptin plus metformin versus saxagliptin alone. (NCT00327015)
Timeframe: Week 24

InterventionPercentage of participants (Number)
Saxagliptin 5 mg + Metformin7.5
Saxagliptin 10 mg + Metformin5.9
Saxagliptin 10 mg21.2

Change From Baseline in A1C at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy

Mean change from baseline in A1C at Week 24, adjusted for baseline value. (NCT00327015)
Timeframe: Baseline, Week 24

,,
Interventionpercent (Mean)
Baseline MeanWeek 24 MeanAdjusted Mean Change from Baseline
Metformin9.437.48-1.99
Saxagliptin 10 mg + Metformin9.537.02-2.49
Saxagliptin 5 mg + Metformin9.416.93-2.53

Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy

Mean change from baseline in FPG at Week 24, adjusted for baseline value. (NCT00327015)
Timeframe: Baseline, Week 24

,,
Interventionmg/dL (Mean)
Baseline MeanWeek 24 MeanAdjusted Mean Change from Baseline
Metformin199.1152.7-47.3
Saxagliptin 10 mg + Metformin204.3140.1-62.2
Saxagliptin 5 mg + Metformin198.9140.2-59.8

Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy

Mean change from baseline in FPG at Week 24, adjusted for baseline value. (NCT00327015)
Timeframe: Baseline, Week 24

,,
Interventionmg/dL (Mean)
Baseline MeanWeek 24 MeanAdjusted Mean Change from Baseline
Saxagliptin 10 mg200.9169.9-30.9
Saxagliptin 10 mg + Metformin204.3140.1-62.2
Saxagliptin 5 mg + Metformin198.9140.2-59.8

Change From Baseline in Hemoglobin A1c (A1C) at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy

Mean change from baseline in A1C at Week 24, adjusted for baseline value. (NCT00327015)
Timeframe: Baseline, Week 24

,,
Interventionpercent (Mean)
Baseline MeanWeek 24 MeanAdjusted Mean Change from Baseline
Saxagliptin 10 mg9.617.86-1.69
Saxagliptin 10 mg + Metformin9.537.02-2.49
Saxagliptin 5 mg + Metformin9.416.93-2.53

Changes From Baseline in Postprandial Glucose (PPG) Area Under the Curve (AUC) Response to an Oral Glucose Tolerance Test (OGTT) at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy

Mean change from baseline for 0 to 180 minutes PPG AUC at Week 24, adjsuted for baseline value. (NCT00327015)
Timeframe: Baseline, Week 24

,,
Interventionmg*min/dL (Mean)
Baseline MeanWeek 24 MeanAdjusted Mean Change from Baseline
Metformin5793742428-15005
Saxagliptin 10 mg + Metformin5721935790-21336
Saxagliptin 5 mg + Metformin5553135324-21080

Changes From Baseline in Postprandial Glucose (PPG) Area Under the Curve (AUC) Response to an Oral Glucose Tolerance Test (OGTT) at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy

Mean change from baseline for 0 to 180 minutes PPG AUC at Week 24, adjusted for baseline value. (NCT00327015)
Timeframe: Baseline, Week 24

,,
Interventionmg*min/dL (Mean)
Baseline MeanWeek 24 MeanAdjusted Mean Change from Baseline
Saxagliptin 10 mg5758441229-16054
Saxagliptin 10 mg + Metformin5721935790-21336
Saxagliptin 5 mg + Metformin5553135324-21080

Change From Baseline in Body Weight at Week 54

(NCT00509262)
Timeframe: Baseline to Week 54

Interventionkg (Least Squares Mean)
Sitagliptin-0.6
Glipizide1.2

Percentage of Participants With Hypoglycemic Events

Percentage of participants with at least one symptomatic hypoglycemic adverse event, excluding data after initiation of glycemic rescue therapy. (NCT00509262)
Timeframe: Baseline up to 28 days following the last dose of study therapy

Interventionpercentage of participants (Number)
Sitagliptin6.2
Glipizide17.0

Change From Baseline in Fasting Plasma Glucose (FPG) at Week 54

(NCT00509262)
Timeframe: Baseline to Week 54

,
Interventionmg/dL (Mean)
BaselineChange from Baseline at Week 54
Glipizide143.9-20.2
Sitagliptin148.6-16.7

Change From Baseline in Hemoglobin A1c (A1C) Levels at Week 54

A1C represents percentage of glycosylated hemoglobin. (NCT00509262)
Timeframe: Baseline to Week 54

,
InterventionPercent of glycosylated hemoglobin (Mean)
BaselineChange from Baseline at Week 54
Glipizide7.79-0.62
Sitagliptin7.76-0.70

Reviews

2 reviews available for glipizide and Body Weight

ArticleYear
Current understanding of feline diabetes: part 2, treatment.
    Journal of feline medicine and surgery, 2000, Volume: 2, Issue:1

    Topics: Animals; Blood Glucose; Body Weight; Cat Diseases; Cats; Diabetes Complications; Diabetes Mellitus;

2000
Sulfonylureas in the treatment of diabetes mellitus--1985.
    Mayo Clinic proceedings, 1985, Volume: 60, Issue:7

    Topics: Blood Glucose; Body Weight; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Drug Therapy, Comb

1985

Trials

13 trials available for glipizide and Body Weight

ArticleYear
[Dapagliflozin versus glipizide as add-on therapy in patients with type 2 diabetes who have inadequate glycemic control with metformin].
    Deutsche medizinische Wochenschrift (1946), 2013, Volume: 138 Suppl 1

    Topics: Aged; Balanitis; Benzhydryl Compounds; Blood Glucose; Body Weight; Candidiasis, Vulvovaginal; Diabet

2013
Durability of glycaemic efficacy over 2 years with dapagliflozin versus glipizide as add-on therapies in patients whose type 2 diabetes mellitus is inadequately controlled with metformin.
    Diabetes, obesity & metabolism, 2014, Volume: 16, Issue:11

    Topics: Benzhydryl Compounds; Blood Glucose; Blood Pressure; Body Weight; Diabetes Mellitus, Type 2; Dose-Re

2014
Durability of glycaemic efficacy over 2 years with dapagliflozin versus glipizide as add-on therapies in patients whose type 2 diabetes mellitus is inadequately controlled with metformin.
    Diabetes, obesity & metabolism, 2014, Volume: 16, Issue:11

    Topics: Benzhydryl Compounds; Blood Glucose; Blood Pressure; Body Weight; Diabetes Mellitus, Type 2; Dose-Re

2014
Durability of glycaemic efficacy over 2 years with dapagliflozin versus glipizide as add-on therapies in patients whose type 2 diabetes mellitus is inadequately controlled with metformin.
    Diabetes, obesity & metabolism, 2014, Volume: 16, Issue:11

    Topics: Benzhydryl Compounds; Blood Glucose; Blood Pressure; Body Weight; Diabetes Mellitus, Type 2; Dose-Re

2014
Durability of glycaemic efficacy over 2 years with dapagliflozin versus glipizide as add-on therapies in patients whose type 2 diabetes mellitus is inadequately controlled with metformin.
    Diabetes, obesity & metabolism, 2014, Volume: 16, Issue:11

    Topics: Benzhydryl Compounds; Blood Glucose; Blood Pressure; Body Weight; Diabetes Mellitus, Type 2; Dose-Re

2014
Saxagliptin efficacy and safety in patients with type 2 diabetes mellitus stratified by cardiovascular disease history and cardiovascular risk factors: analysis of 3 clinical trials.
    Postgraduate medicine, 2014, Volume: 126, Issue:6

    Topics: Adamantane; Adult; Blood Glucose; Body Weight; Cardiovascular Diseases; Diabetes Mellitus, Type 2; D

2014
Saxagliptin efficacy and safety in patients with type 2 diabetes mellitus stratified by cardiovascular disease history and cardiovascular risk factors: analysis of 3 clinical trials.
    Postgraduate medicine, 2014, Volume: 126, Issue:6

    Topics: Adamantane; Adult; Blood Glucose; Body Weight; Cardiovascular Diseases; Diabetes Mellitus, Type 2; D

2014
Saxagliptin efficacy and safety in patients with type 2 diabetes mellitus stratified by cardiovascular disease history and cardiovascular risk factors: analysis of 3 clinical trials.
    Postgraduate medicine, 2014, Volume: 126, Issue:6

    Topics: Adamantane; Adult; Blood Glucose; Body Weight; Cardiovascular Diseases; Diabetes Mellitus, Type 2; D

2014
Saxagliptin efficacy and safety in patients with type 2 diabetes mellitus stratified by cardiovascular disease history and cardiovascular risk factors: analysis of 3 clinical trials.
    Postgraduate medicine, 2014, Volume: 126, Issue:6

    Topics: Adamantane; Adult; Blood Glucose; Body Weight; Cardiovascular Diseases; Diabetes Mellitus, Type 2; D

2014
Saxagliptin efficacy and safety in patients with type 2 diabetes mellitus stratified by cardiovascular disease history and cardiovascular risk factors: analysis of 3 clinical trials.
    Postgraduate medicine, 2014, Volume: 126, Issue:6

    Topics: Adamantane; Adult; Blood Glucose; Body Weight; Cardiovascular Diseases; Diabetes Mellitus, Type 2; D

2014
Saxagliptin efficacy and safety in patients with type 2 diabetes mellitus stratified by cardiovascular disease history and cardiovascular risk factors: analysis of 3 clinical trials.
    Postgraduate medicine, 2014, Volume: 126, Issue:6

    Topics: Adamantane; Adult; Blood Glucose; Body Weight; Cardiovascular Diseases; Diabetes Mellitus, Type 2; D

2014
Saxagliptin efficacy and safety in patients with type 2 diabetes mellitus stratified by cardiovascular disease history and cardiovascular risk factors: analysis of 3 clinical trials.
    Postgraduate medicine, 2014, Volume: 126, Issue:6

    Topics: Adamantane; Adult; Blood Glucose; Body Weight; Cardiovascular Diseases; Diabetes Mellitus, Type 2; D

2014
Saxagliptin efficacy and safety in patients with type 2 diabetes mellitus stratified by cardiovascular disease history and cardiovascular risk factors: analysis of 3 clinical trials.
    Postgraduate medicine, 2014, Volume: 126, Issue:6

    Topics: Adamantane; Adult; Blood Glucose; Body Weight; Cardiovascular Diseases; Diabetes Mellitus, Type 2; D

2014
Saxagliptin efficacy and safety in patients with type 2 diabetes mellitus stratified by cardiovascular disease history and cardiovascular risk factors: analysis of 3 clinical trials.
    Postgraduate medicine, 2014, Volume: 126, Issue:6

    Topics: Adamantane; Adult; Blood Glucose; Body Weight; Cardiovascular Diseases; Diabetes Mellitus, Type 2; D

2014
Long-term glycaemic response and tolerability of dapagliflozin versus a sulphonylurea as add-on therapy to metformin in patients with type 2 diabetes: 4-year data.
    Diabetes, obesity & metabolism, 2015, Volume: 17, Issue:6

    Topics: Aged; Benzhydryl Compounds; Blood Glucose; Blood Pressure; Body Weight; Diabetes Mellitus, Type 2; D

2015
Efficacy and safety of sitagliptin versus glipizide in patients with type 2 diabetes and moderate-to-severe chronic renal insufficiency.
    Diabetes care, 2013, Volume: 36, Issue:5

    Topics: Body Weight; Diabetes Mellitus, Type 2; Female; Glipizide; Humans; Hypoglycemic Agents; Male; Pyrazi

2013
Clinical utility of oral hypoglycemic agents in the management of patients with noninsulin-dependent diabetes mellitus.
    The American journal of medicine, 1983, Nov-30, Volume: 75, Issue:5B

    Topics: Administration, Oral; Adult; Age Factors; Blood Glucose; Body Weight; Clinical Trials as Topic; Diab

1983
Glipizide in the treatment of maturity-onset diabetes: a multi-centre, out-patient study.
    Current medical research and opinion, 1978, Volume: 5, Issue:5

    Topics: Adult; Aged; Blood Glucose; Body Weight; Clinical Trials as Topic; Diabetes Mellitus; Female; Glipiz

1978
Conversion from low-dose insulin therapy to glipizide in patients with non-insulin-dependent diabetes mellitus.
    The American journal of medicine, 1987, Sep-18, Volume: 83, Issue:3A

    Topics: Adult; Blood Glucose; Body Weight; Clinical Trials as Topic; Diabetes Mellitus, Type 2; Drug Adminis

1987
Achieving therapeutic goals in insulin-using diabetic patients with non-insulin-dependent diabetes mellitus. A weight reduction-exercise-oral agent approach.
    The American journal of medicine, 1987, Sep-18, Volume: 83, Issue:3A

    Topics: Adult; Aged; Behavior Therapy; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Diet, Reducing

1987
Lack of primary effect of sulphonylurea (glipizide) on plasma lipoproteins and insulin action in former type 2 diabetics with attenuated insulin secretion.
    European journal of clinical pharmacology, 1987, Volume: 33, Issue:3

    Topics: Blood Glucose; Body Weight; C-Peptide; Diabetes Mellitus, Type 2; Double-Blind Method; Glipizide; Gl

1987
Therapeutic equivalence of once- and thrice-daily glipizide.
    European journal of clinical pharmacology, 1986, Volume: 31, Issue:1

    Topics: Adult; Blood Glucose; Body Weight; Clinical Trials as Topic; Diabetes Mellitus, Type 2; Drug Adminis

1986
Moderate weight loss and sulfonylurea treatment of non-insulin-dependent diabetes mellitus. Combined effects.
    Archives of internal medicine, 1985, Volume: 145, Issue:4

    Topics: Blood Glucose; Body Weight; Combined Modality Therapy; Diabetes Mellitus, Type 2; Diet, Reducing; Fa

1985
Pharmacokinetics and metabolic effects of glibenclamide and glipizide in type 2 diabetics.
    European journal of clinical pharmacology, 1985, Volume: 28, Issue:6

    Topics: Aged; Blood Glucose; Body Weight; C-Peptide; Diabetes Mellitus, Type 2; Double-Blind Method; Erythro

1985

Other Studies

8 other studies available for glipizide and Body Weight

ArticleYear
Polypharmacy (herbal and synthetic drug combination): a novel approach in the treatment of type-2 diabetes and its complications in rats.
    Journal of natural medicines, 2013, Volume: 67, Issue:3

    Topics: Administration, Oral; Animals; Annona; Behavior, Animal; Blood Glucose; Body Weight; Catalase; Diabe

2013
Clinical decisions. Management of type 2 diabetes--polling results.
    The New England journal of medicine, 2008, Feb-14, Volume: 358, Issue:7

    Topics: Body Weight; Cost-Benefit Analysis; Diabetes Mellitus, Type 2; Drug Therapy, Combination; Exenatide;

2008
Sulfonylurea treatment of insulin-independent diabetes mellitus.
    Metabolism: clinical and experimental, 1980, Volume: 29, Issue:5

    Topics: Blood Glucose; Body Weight; Diabetes Mellitus; Diet, Diabetic; Glipizide; Humans; Hypoglycemic Agent

1980
Impaired effect of sulfonylurea following increased dosage.
    European journal of clinical pharmacology, 1982, Volume: 22, Issue:1

    Topics: Aged; Blood Glucose; Body Weight; Chlorpropamide; Diabetes Mellitus; Dose-Response Relationship, Dru

1982
Effect of an orally administered sulfonylurea, glipizide, for treatment of diabetes mellitus in cats.
    Journal of the American Veterinary Medical Association, 1993, Sep-15, Volume: 203, Issue:6

    Topics: Administration, Oral; Alanine Transaminase; Alkaline Phosphatase; Animals; Blood Glucose; Body Weigh

1993
Prospective multicenter study of sulfonylurea ingestion in children.
    The Journal of pediatrics, 1997, Volume: 131, Issue:1 Pt 1

    Topics: Accidents; Administration, Oral; Blood Glucose; Body Weight; Child; Child, Preschool; Confidence Int

1997
A retrospective analysis of the efficacy and safety of metformin in the African-American patient.
    Journal of the National Medical Association, 1997, Volume: 89, Issue:11

    Topics: Adult; Aged; Aged, 80 and over; Black People; Body Weight; Diabetes Mellitus, Type 2; Drug Therapy,

1997
Long-term effects of glipizide on insulin secretion and blood glucose control in patients with non-insulin-dependent diabetes mellitus.
    European journal of clinical pharmacology, 1992, Volume: 42, Issue:1

    Topics: Blood Glucose; Body Mass Index; Body Weight; C-Peptide; Diabetes Mellitus, Type 2; Energy Intake; Gl

1992