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

Phase 1

• Conditions: Type 2 diabetes mellitus; MedDRA version: 9.1 Level: LLT Classification code 10012601 Term: Diabetes mellitus

• Registration Number: EUCTR2008-002121-36-BG
• Lead Sponsor: Merck & Co. Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-01-21
• Study Completion: 2010-06-25
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 950

Inclusion Criteria

Patient is 21 to 70 years old and currently on a stable dose of insulin for Type 2 Diabetes.
HbA1c at visit 4 ( randomization) HbA1c =7.5% and =11.0%
BMI > 20kg/m² and <43 kg/m² at visit 1 ( screening)
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
<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> ;<br> 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> ;<br> Primary end point(s): HbA1c<br> FPG<br>