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

Condition(s) targeted: Diabetes Mellitus, Type 2; Renal Insufficiency, Chronic

Intervention: Sitagliptin (Drug); Glipizide (Drug); Placebo for Sitagliptin (Drug); Placebo for Glipizide (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: 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.

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

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

Percentage of Participants With Hypoglycemic Events

Secondary outcome:

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

Change From Baseline in Body Weight at Week 54

Minimum age: 30 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Has type 2 diabetes mellitus

- Has moderate or severe renal insufficiency

Exclusion Criteria:

- Has type 1 diabetes mellitus or a history of ketoacidosis

- Is on a new weight loss program

- Has active liver disease

- Is on dialysis or is likely to need dialysis during the study

Starting date: October 2007
Last updated: April 27, 2015