Safety/Efficacy of Sitagliptin in Patient w/ Type 2 Diabetes (0431-801)

Phase 3

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: Sitagliptin

• Registration Number: NCT00541775
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

The purpose of this study is to test the safety and effectiveness of sitagliptin in patients with type 2 diabetes.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-06
• Primary Completion: 2007-03
• Study Completion: 2007-03
• Study First Submitted: 2007-10-05
• Study First Submitted QC: 2007-10-05
• Study First Posted: 2007-10-10
• Results First Submitted: 2010-05-17
• Results First Submitted QC: 2010-05-17
• Results First Posted: 2010-06-17
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-21
• Last Update Posted: 2015-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 273

Inclusion Criteria

• Patient has Type 2 diabetes
• Currently taking metformin >1500 mg/day for at least 10 weeks
• Male or female

Read More

Exclusion Criteria

• Patient has peripheral edema
• History of type 1 diabetes
• Patient required insulin within prior 8 weeks
• Have participated or are currently participating in another study with an investigational compound or device within 12 weeks of starting this study
• Participating in a weight loss program

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sitagliptin	Sitagliptin	sitagliptin 100 mg

Primary Outcome Measures

Name	Time	Method
Hemoglobin A1C (A1C) at Week 18	Baseline and 18 Weeks	A1C is measured as percent. Thus, this change from baseline reflects the Week 18 A1C percent minus the Week 0 A1C percent.; The study hypothesis comparison was between sitagliptin versus placebo.

Secondary Outcome Measures

Name	Time	Method
2-hour Post-meal Glucose (PMG) at Week 18	Baseline and 18 Weeks	The change from baseline is the Week 18 PMG minus the Week 0 PMG.
Fasting Plasma Glucose (FPG) at Week 18	Baseline and 18 Weeks	The change from baseline is the Week 18 FPG minus the Week 0 FPG.