NCT00509262

Sitagliptin Versus Glipizide in Participants With Type 2 Diabetes Mellitus and Chronic Renal Insufficiency (MK-0431-063 AM1)

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 426 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 30 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to compare how sitagliptin and glipizide lower blood glucose levels in participants with moderate or severe renal insufficiency.

Conditions

• Diabetes Mellitus, Type 2
• Renal Insufficiency, Chronic

Interventions

Type	Name	Description
DRUG	Sitagliptin	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	Glipizide	Participants will receive glipizide 2.5 mg (1/2 tablet) orally once daily up to 20 mg orally daily (10 mg twice daily)
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
DRUG	Placebo for Glipizide	Participants will receive 1/2 tablet of placebo for glipizide orally once daily up to 2 tablets orally twice daily

Timeline

• Start date: 2007-10-09
• Primary completion: 2011-03-16
• Completion: 2011-03-16
• First posted: 2007-07-31
• Last updated: 2017-05-12
• Results posted: 2012-03-28