Initial Combination With Pioglitazone Study (0431-064)

Phase 3

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: sitagliptin 100 mg q.d./pioglitazone 30 mg q.d

• Registration Number: NCT00397631
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

A clinical study to evaluate the safety and efficacy of the initial combination therapy with sitagliptin and pioglitazone in patients with type 2 diabetes mellitus not on treatment with insulin or oral antihyperglycemic therapy.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2006-11-08
• Study First Submitted QC: 2006-11-08
• Study First Posted: 2006-11-09
• Study Start: 2006-12-19
• Primary Completion: 2008-06-28
• Study Completion: 2008-06-28
• Results First Submitted: 2009-05-19
• Results First Submitted QC: 2009-05-19
• Results First Posted: 2009-07-10
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-07
• Last Update Posted: 2017-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 520

Inclusion Criteria

• Patients ≥18 years old with Type 2 Diabetes Mellitus (a specific type of diabetes)

General

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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 4 months
• Patient was on >4 weeks (cumulatively) of antihyperglycemic therapy (oral or insulin) over the prior 2 years

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	sitagliptin 100 mg q.d./pioglitazone 30 mg q.d	sitagliptin 100 mg q.d./pioglitazone 30 mg q.d.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in HbA1c (Hemoglobin A1C) at Week 24	Baseline and 24 weeks	HbA1c is measured as a percent. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the Week 0 HbA1c percent.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in FPG (Fasting Plasma Glucose) at Week 24	Baseline and Week 24	Change from baseline at Week 24 is defined as Week 24 minus Week 0.
Change From Baseline in 2-hour PPG (Post-prandial Glucose) at Week 24	Baseline and Week 24	Change from baseline at Week 24 is defined as Week 24 minus Week 0.