Sulfonylurea Add-on Study in Patients With Type 2 Diabetes Mellitus (0431-035)

Phase 3

Completed

• Conditions: Diabetes Mellitus, Type 2

• Registration Number: NCT00106704
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

The purpose of this clinical study is to determine the safety and efficacy of an investigational drug in patients with Type 2 diabetes mellitus.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-03
• Study First Submitted: 2005-03-29
• Study First Submitted QC: 2005-03-29
• Study First Posted: 2005-03-30
• Primary Completion: 2006-06
• Study Completion: 2007-01
• Results First Submitted: 2010-11-19
• Results First Submitted QC: 2010-11-19
• Results First Posted: 2010-12-17
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-04
• Last Update Posted: 2015-07-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 441

Inclusion Criteria

• Patients with Type 2 Diabetes Mellitus with inadequate glycemic control

Exclusion Criteria

• Patients with Type 1 Diabetes Mellitus

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in FPG at Week 24	Baseline and 24 Weeks	The change from baseline is the Week 24 Fasting Plasma Glucose (FPG) minus the Week 0 FPG.