Treatment of Type 2 Diabetes MedDRA version: 9.1 Level: LLT Classification code 10012601 Term: Diabetes mellitus
Conditions
Sponsors
Merck & Co., Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patient is 21 to 70 years old and currently on a stable dose of insulin for Type 2 Diabetes. 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1) After 14 weeks, to assess the effect of treatment with MK-0941 compared with placebo on HbA1c when added to basal insulin. 2) To assess the safety and tolerability of MK-0941. ; Secondary Objective: 1) After 14 weeks, to assess the effect of treatment with MK-0941 compared with placebo on 2-hour postprandial glucose when added to basal insulin. 2) After 14 weeks, to assess the effect of treatment with MK-0941 compared with placebo on fasting plasma glucose when added to basal insulin. ;Primary end point(s): HbA1c | — |
Countries
Austria, Bulgaria, Denmark, Finland, France, Germany, Hungary, Italy, Sweden
Outcome results
None listed