A Phase IIa, Multicenter, Randomized, Placebo- and Active-Comparator Controlled,Cross-Over Clinical Trial to Study the Safety and Efficacy of MK-3577 in Patients withType 2 Diabetes Mellitus Who Have Inadequate Glycemic Control - A Study of the Safety and Efficacy of MK-3577 in Patients with Type 2 Diabetes Mellitus.

• Conditions: Type 2 Diabetes Mellitus; MedDRA version: 9.1Level: LLTClassification code 10012601Term: Diabetes mellitus

• Registration Number: EUCTR2009-009517-18-DE
• Lead Sponsor: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08-07
• Last Update Posted: 29 October 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 333

Inclusion Criteria

T2DM patients aged 18-70 years who are either drug naïve (AIC range of 6.5-9.5%) or on oral AHA monotherapy or low-dose combination therapy (AIC range of 6.0-9.0%)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

No treatment with PPAR-? agonists (TZDs) or statins within 12 weeks

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the 24-hour weighted mean glucose (WMG)-lowering efficacy, safety and tolerability of MK-3577;Secondary Objective: To assess the effect of morning and/or evening administration of MK-3577 on fasting glucose levels, 2-hour postprandial glucose levels after the morning meal and LDL-C;Primary end point(s): 24-hour Weighted Mean Glucose (WMG)