MK0431 Monotherapy Study in Patients With Type 2 Diabetes Mellitus (0431-040)

Phase 3

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: sitagliptin phosphate

• Registration Number: NCT00289848
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

This is a clinical study to determine the safety and efficacy of an investigational drug in patients with type 2 diabetes mellitus.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-02-07
• Study First Submitted QC: 2006-02-08
• Study First Posted: 2006-02-10
• Study Start: 2006-03
• Primary Completion: 2007-03
• Study Completion: 2007-03
• Results First Submitted: 2010-03-18
• Results First Submitted QC: 2010-03-18
• Results First Posted: 2010-04-02
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-20
• Last Update Posted: 2015-06-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 530

Inclusion Criteria

• Patients have Type 2 Diabetes Mellitus and have laboratory results that are within the values established by the study such as an Hemoglobin A1c (HbA1c) >=7.5% and <=11% and a Fasting Plasma Glucose (FPG) >=130 mg/dL and <=280 mg/dL

Exclusion Criteria :

• Patients have Type 1 Diabetes Mellitus or required insulin therapy within the past 12 months

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	sitagliptin phosphate	sitagliptin 100 mg

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Hemoglobin A1c (HbA1c) at Week 18	Baseline and Week 18	A1C was measured as a percent. Thus, this change from baseline reflects the Week 18 A1C percent minus the Week 0 A1C percent.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 18	Baseline and Week 18	Change from baseline at Week 18 is defined as Week 18 FPG minus Week 0 FPG.
Change From Baseline in 2-hr Post-Meal Glucose (PMG) at Week 18	Baseline and Week 18	Change from baseline at Week 18 is defined as Week 18 minus Week 0.