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

Phase 3

Completed

• Conditions: Diabetes Mellitus, Type 2; Chronic Renal Insufficiency
• Interventions: Drug: Placebo to Sitagliptin; Drug: sitagliptin; Drug: glipizide; Drug: Placebo to glipizide

• Registration Number: NCT00095056
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2004-10
• Study First Submitted: 2004-10-29
• Study First Submitted QC: 2004-10-29
• Study First Posted: 2004-11-01
• Primary Completion: 2006-07
• Study Completion: 2006-07
• Results First Submitted: 2010-06-22
• Results First Submitted QC: 2010-06-22
• Results First Posted: 2010-07-23
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-12
• Last Update Posted: 2015-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 91

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Safety and Tolerability of Sitagliptin After 12 Weeks of Treatment	Week 0 through Week 12	Safety and tolerability were measured in terms of the number of patients with clinical adverse experiences (CAEs), serious CAEs, drug-related CAEs, laboratory adverse experiences (LAEs), serious LAEs, and drug-related LAEs. Drug-relationship was assessed by the study investigator according to his/her best clinical judgment.

Secondary Outcome Measures

Name	Time	Method
Safety and Tolerability of Sitagliptin Over 54 Weeks	Week 0 through Week 54	Safety and tolerability were measured in terms of the number of patients with clinical adverse experiences (CAEs), serious CAEs, drug-related CAEs, laboratory adverse experiences (LAEs), serious LAEs, and drug-related LAEs. Drug-relationship was assessed by the study investigator according to his/her best clinical judgment.