Status:
TERMINATED
Dose Range Finding Study of MK-0941 in Patients With Type 2 Diabetes Mellitus on Insulin (MK-0941-007 AM3 EXT1 AM1)(TERMINATED)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
21-70 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to test the effect of MK-0941 as add-on therapy for participants taking insulin for type 2 diabetes mellitus. The primary hypotheses of this study are that treatment with ...
Detailed Description
This study is a 54-week randomized, double-blind base study with an optional 104-week extension study (MK-0941-007-11). Beginning on Week 16, participants not randomized to the maximum dose of MK-0941...
Eligibility Criteria
Inclusion
- has type 2 diabetes mellitus
- has body mass index \>20 and \<43 kg/m\^2
- is a male, or a female who is unlikely to conceive
- currently on a stable dose of insulin with or without metformin for Type 2 diabetes mellitus
- Extension Study
- completed the base study either on double-blind study medication or as part of the post-treatment follow up population
- had ≥85% compliance with double-blind and open-label medication during the base study double-blind treatment period
Exclusion
- has any history of Type 1 diabetes mellitus or ketoacidosis
- has received more that 1 week of thiazolidinedione (such as pioglitazone or rosiglitazone) therapy or injectable increatin-based therapy (such as Byetta) within the prior 8 weeks
- has had ≥2 episodes during their lifetime or \>1 episode within the past year resulting in hypoglycemic seizures, comas, or unconsciousness
- 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
- has undergone surgery within 30 days prior to Visit 1 or has planned major surgery
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
813 Patients enrolled
Trial Details
Trial ID
NCT00767000
Start Date
October 1 2008
End Date
June 1 2010
Last Update
February 19 2015
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