A Phase IIb/III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Dose-Range Finding Clinical Trial of MK-0941 in Patients With Type 2 Diabetes MellitusWith Inadequate Glycemic Control on Insulin - Dose-Range Finding Study of MK-0941 in Patients with Type 2 Diabetes on Insuli

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

• Registration Number: EUCTR2008-002121-36-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: 2009-01-20
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 550

Inclusion Criteria

Patient is 21 to 70 years old and currently on a stable dose of insulin for Type 2 Diabetes.
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

Patient has any history of Type 1 Diabetes; patient is on a weight loss program and is not in the maintenance phase, or patient is taking a weight loss medication (e.g., orlistat, sibutramine, rimonabant) within 8 weeks of Visit 1;patient has undergone surgery within 30 days prior to Visit 1 or has planned major surgery.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: 1) After 14 weeks, to assess the effect of treatment with MK-0941<br>compared with placebo on HbA1c when added to basal insulin.<br>2) To assess the safety and tolerability of MK-0941.<br>;Secondary Objective: 1) After 14 weeks, to assess the effect of treatment with MK-0941<br>compared with placebo on 2-hour postprandial glucose when added to basal insulin.<br>2) After 14 weeks, to assess the effect of treatment with MK-0941<br>compared with placebo on fasting plasma glucose when added to basal insulin.<br><br>;Primary end point(s): HbA1c