Clinical trial NCT00767000: Dose Range Finding Study of MK-0941 in Patients With Type 2 Diabetes Mellitus on Insulin (MK-0941-007 AM3 EXT1 AM1)(TERMINATED)
Official title: A Phase IIb, Multicenter, Randomized, Double-Blind, Placebo-Controlled Dose-Range Finding Clinical Trial of MK0941 in Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Insulin
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2008-10-06
Enrollment: 813
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

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 could up-titrate to MK-0941 40 mg three times daily. Participants who complete the 54-week base study are eligible to enter the extension study and will remain in the treatment group to which they were assigned in the base study.

Eligibility 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

Primary outcomes:
measure: Change in Hemoglobin A1c (HbA1c) Level
timeFrame: Baseline and Weeks 14, 54, 106, and 158
measure: Percentage of Participants Who Experienced at Least One Adverse Event
timeFrame: Entire study including 54-week study and 104-week extension
measure: Percentage of Participants Who Discontinued Study Medication Due to an Adverse Event
timeFrame: Entire study including 54-week study and 104-week extension
Secondary outcomes:
measure: Change in the Two-hour Post Meal Glucose Level
timeFrame: Baseline and Weeks 14, 54, 106, and 158
measure: Change in the Fasting Plasma Glucose Level
timeFrame: Baseline and Weeks 14, 54, 106, and 158
measure: Percentage of Participants Who Achieve an HbA1c of <7.0%
timeFrame: Weeks 106 and 158
measure: Percentage of Participants Achieving an HbA1c of <7.0% at Week 54 Who Maintain an HbA1c of <7.0%
timeFrame: Weeks 54, 106 and 158
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Meininger GE, Scott R, Alba M, Shentu Y, Luo E, Amin H, Davies MJ, Kaufman KD, Goldstein BJ. Effects of MK-0941, a novel glucokinase activator, on glycemic control in insulin-treated patients with type 2 diabetes. Diabetes Care. 2011 Dec;34(12):2560-6. doi: 10.2337/dc11-1200. Epub 2011 Oct 12.