An Investigational Drug in Patients With Type 2 Diabetes Mellitus and Chronic Renal Insufficiency (0431-028)(COMPLETED)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus, Type 2; Chronic Renal Insufficiency

Treatments: Drug: glipizide; Drug: Placebo to glipizide; Drug: Placebo to Sitagliptin; Drug: sitagliptin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00095056

0431-028

2004_054

Details and patient eligibility

About

The purpose of this study is to determine the safety and tolerability of an investigational drug in patients with Type 2 Diabetes Mellitus (a specific type of diabetes) and Chronic Renal Insufficiency (inadequate kidney function).

Enrollment: 91 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who are at least 18 years of age diagnosed with type 2 diabetes mellitus (T2DM) (a specific type of diabetes).
• Patient has renal (kidney) insufficiency (inadequate kidney function)

Exclusion criteria

• Patient has had heart problems (such as a heart attack or chest pain) or stroke within the past 6 months or any condition or therapy which, in the opinion of the investigator, may not be in the patient's best interest to participate.
• Pregnant or breast feeding

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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91 participants in 2 patient groups, including a placebo group

Sitagliptin

Experimental group

Description:

Participants in the Sitagliptin treatment sequence will receive sitagliptin in Phase A and placebo to glipizide in Phase B.

Treatment:

Drug: glipizide

Drug: Placebo to glipizide

Drug: sitagliptin

Placebo

Placebo Comparator group

Description:

Participants in the Placebo treatment sequence will receive placebo to sitagliptin in Phase A and glipizide in Phase B.

Treatment:

Drug: glipizide

Drug: Placebo to Sitagliptin