Sitagliptin Versus Glipizide in Participants With Type 2 Diabetes Mellitus and Chronic Renal Insufficiency (MK-0431-063 AM1)
This study has been completed.
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
First received: July 27, 2007
Last updated: August 30, 2013
Last verified: August 2013
The purpose of the study is to compare how sitagliptin and glipizide lower blood glucose levels in participants with moderate or severe renal insufficiency.
Diabetes Mellitus, Type 2
Renal Insufficiency, Chronic
Drug: Placebo for Sitagliptin
Drug: Placebo for Glipizide
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|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|
Resource links provided by NLM:
MedlinePlus related topics: Chronic Kidney Disease Diabetes Diabetes Medicines Diabetes Type 2 Kidney FailureU.S. FDA Resources
Further study details as provided by Merck Sharp & Dohme Corp.:
Primary Outcome Measures:
- Change From Baseline in Hemoglobin A1c (A1C) Levels at Week 54 [ Time Frame: Baseline to Week 54 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: No ]
- Change From Baseline in Body Weight at Week 54 [ Time Frame: Baseline to Week 54 ] [ Designated as safety issue: Yes ]
|Study Start Date:||October 2007|
|Study Completion Date:||March 2011|
|Primary Completion Date:||March 2011 (Final data collection date for primary outcome measure)|
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
Other Names: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: GlucotrolDrug: 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
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