Dose Range Finding Study of MK-0941 in Patients With Type 2 Diabetes Mellitus on Insulin (MK-0941-007 AM3 EXT1 AM1)(TERMINATED)

• Status: Terminated
• Trial end date: 2010-06-01
• Target enrollment: 0
• Participant gender: All

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 MK-0941 added to insulin will provide greater reduction in hemoglobin A1c (HbA1c) level than will placebo added to insulin at 14 weeks, and that MK-0941 will be well-tolerated at 1 or more doses that demonstrate efficacy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Insulin; Insulin Glargine; Insulin, Globin Zinc; Metformin

Criteria

Inclusion Criteria:

• 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 Inclusion Criteria:

• 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 Criteria:

• 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