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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus, Type 2; Renal Insufficiency, Chronic

Treatments: Drug: Placebo for Sitagliptin; Drug: Glipizide; Drug: Placebo for Glipizide; Drug: Sitagliptin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00509262

2007_549 (Other Identifier)

0431-063

Details and patient eligibility

About

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

Enrollment: 426 patients

Sex: All

Ages: 30+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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426 participants in 2 patient groups

Sitagliptin

Experimental group

Description:

Sitagliptin + Placebo for Glipizide

Treatment:

Drug: Sitagliptin

Drug: Placebo for Glipizide

Glipizide

Active Comparator group

Description:

Glipizide + Placebo for Sitagliptin

Treatment:

Drug: Placebo for Sitagliptin

Drug: Glipizide