Sitagliptin Versus Glipizide in Participants With Type 2 Diabetes Mellitus and Chronic Renal Insufficiency (MK-0431-063 AM1)
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|ClinicalTrials.gov Identifier: NCT00509262|
Recruitment Status : Completed
First Posted : July 31, 2007
Results First Posted : March 28, 2012
Last Update Posted : May 12, 2017
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
The purpose of the study is to compare how sitagliptin and glipizide lower blood glucose levels in participants with moderate or severe renal insufficiency.
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Type 2 Renal Insufficiency, Chronic||Drug: Sitagliptin Drug: Glipizide Drug: Placebo for Sitagliptin Drug: Placebo for Glipizide||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||426 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||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|
|Actual Study Start Date :||October 9, 2007|
|Actual Primary Completion Date :||March 16, 2011|
|Actual Study Completion Date :||March 16, 2011|
Sitagliptin + Placebo for Glipizide
Participants with moderate renal insufficiency will receive two sitagliptin 25 mg tablets orally daily; participants with severe renal insufficiency will receive one sitagliptin 25 mg tablet orally daily
Drug: Placebo for Glipizide
Participants will receive 1/2 tablet of placebo for glipizide orally once daily up to 2 tablets orally twice daily
Active Comparator: Glipizide
Glipizide + Placebo for Sitagliptin
Participants will receive glipizide 2.5 mg (1/2 tablet) orally once daily up to 20 mg orally daily (10 mg twice daily)
Other Name: Glucotrol
Drug: Placebo for Sitagliptin
Participants with moderate renal insufficiency will receive 2 placebo for sitagliptin tablets orally daily; participants with severe renal insufficiency will receive 1 placebo for sitagliptin tablet orally daily
Primary Outcome Measures :
- Change From Baseline in Hemoglobin A1c (A1C) Levels at Week 54 [ Time Frame: Baseline to Week 54 ]A1C represents percentage of glycosylated hemoglobin.
- Percentage of Participants With Hypoglycemic Events [ Time Frame: Baseline up to 28 days following the last dose of study therapy ]Percentage of participants with at least one symptomatic hypoglycemic adverse event, excluding data after initiation of glycemic rescue therapy.
Secondary Outcome Measures :
- Change From Baseline in Fasting Plasma Glucose (FPG) at Week 54 [ Time Frame: Baseline to Week 54 ]
- Change From Baseline in Body Weight at Week 54 [ Time Frame: Baseline to Week 54 ]
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