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

Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

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.

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.

Clinical Details

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

Eligibility

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

Locations and Contacts

Additional Information

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

Page last updated: August 23, 2015

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