MK0431A vs. Pioglitazone in Patients With Type 2 Diabetes Mellitus (0431A-066)

Phase 3

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: sitagliptin phosphate (+) metformin hydrochloride

• Registration Number: NCT00532935
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

A study to evaluate the efficacy and safety of MK0431A in comparison to a commonly used medication in patients with type 2 diabetes

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-09-19
• Study First Submitted QC: 2007-09-20
• Study First Posted: 2007-09-21
• Study Start: 2008-01-26
• Primary Completion: 2009-10-23
• Study Completion: 2009-10-23
• Results First Submitted: 2010-09-23
• Results First Submitted QC: 2010-09-23
• Results First Posted: 2010-10-18
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-11
• Last Update Posted: 2017-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 517

Inclusion Criteria

• Patient has type 2 diabetes mellitus
• Patient is inadequately controlled and not on treatment with insulin or oral antihyperglycemic therapy

General

Exclusion Criteria

• Patient has a history of type 1 diabetes mellitus or history of ketoacidosis
• Patient was on antihyperglycemic agent therapy (oral or insulin) within the prior 12 weeks
• Patient was on >4 weeks (cumulatively) of antihyperglycemic therapy (oral or insulin) over the prior 3 years

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	sitagliptin phosphate (+) metformin hydrochloride	Sitagliptin phosphate (+) metformin hydrochloride

Primary Outcome Measures

Name	Time	Method
Change From Baseline in A1C at Week 32	Baseline and Week 32	A1C is measured as a percent. Thus this change from baseline reflects the Week 32 A1C percent minus the baseline A1C percent

Secondary Outcome Measures

Name	Time	Method
Percent of Participants With A1C <7.0% at Week 32	Week 32
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 1	Baseline and Week 1	Change from baseline reflects the Week 1 FPG minus the baseline FPG. At Week 1, the dose was 50/500 mg b.i.d. for Sita/Met FDC and 30 mg q.d. for pioglitazone
Change From Baseline in 2-hour Post-Meal Glucose (PMG) at Week 32	Baseline and Week 32	Change from baseline reflects the Week 32 2-hour PMG minus the baseline 2-hour PMG
Change From Baseline in FPG at Week 32	Baseline and Week 32	Change from baseline reflects the Week 32 FPG minus the baseline FPG