A 104-Week Extension to: 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 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-SE

Lead Sponsor: Merck Sharp & Dohme (Sweden) AB

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 550

Inclusion Criteria

1) Patient completed the base study either as a patient on double-blind study medication or as part of the post-treatment follow-up population.

2) Patients on double-blind study medication must have >85% compliance with double-blind open-label study medication during the base study double-blind treatment period.

3) Patient understands the extension study procedures and agrees to participate in the extension by giving written informed consent.

4) Women of childbearing potential on double-blind study medication must continue to comply with the protocol-specified contraceptive methods as previously outlined in the base study.
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 currently meets any of the base study criteria for discontinuation from study drug.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 1) After 106 and 158 weeks, to assess the effect of treatment with MK-0941<br>compared with placebo on HbA1c when added to basal insulin.<br>2) After 106 and 158 weeks, to assess the safety and tolerability of MK-0941.<br>;Secondary Objective: 1) After 106 and 158 weeks, to assess the effect of treatment with MK-0941<br>compared with placebo on fasting plasma glucose when added to basal insulin.<br>2) After 106 and 158 weeks, to assess the proportion of patients who acheive an HbA1c of <7.0% (<6.5%).<br>3) For patients who have acheived an HbA1c of <7.0% (<6.5%) at week 54, to assess the proportion of patients who maintain the HbA1c of <7.0% (<6.5%) after 106 and 158 weeks.<br>4) After 106 and 158 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><br>;Primary end point(s): HbA1c

Secondary Outcome Measures