Type II Diabetes MedDRA version: 9.0 Level: LLT Classification code 10045242
Conditions
Interventions
Product Name: MK-0893
Product Code: NA
Pharmaceutical Form: Tablet
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Tablet
Ro
Sponsors
Merck & Co., Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patient is a male or female (non-childbearing potential) between the ages of 21 and 65 years with type 2 diabetes and whose weight is a Body Mass Index (BMI) that is from 20 to 40 kg/m2. 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) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subject has clinically significant abnormalities in the physical examination or laboratory safety tests, history of cardiovascular disease, renal disease, type 1 diabetes, hepatic disease, and neoplastic disease or in the opinion of the investigator has any condition which may compromise safety or the clear interpretation of data from the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Main objective: (1) To assess the effect of treatment with MK-0893 compared to placebo on 24-hour weighted mean glucose (WMG). (2) To assess the safety and tolerability of MK-0893. ;Secondary Objective: Secondary objectives : (1) To assess the effects of MK-0893 on parameters of glycemic control (i.e., fasting plasma glucose, postprandial glucose excursions, fructosamine, and 1-5 anhydroglucitol) (2) To assess the effect of treatment with metformin compared to placebo on 24-hour weighted mean glucose (WMG) (3) To estimate the difference in the effects of MK-0893 and metformin on 24-hour WMG and other parameters of glycemic control (i.e., fasting plasma glucose, postprandial glucose excursions, fructosamine, and 1-5 anhydroglucitol). (4) To estimate the effects of MK-0893 on glucagon, GLP-1, insulin and C-peptide levels.(5) To estimate the effects of MK-0893 on 24-hour WMG as assessed by continuous glucose monitoring. ;Primary end point(s): In patients with type 2 diabetes mellitus after 28 days of treatment, MK-0893 will provide significantly greater reduction in 24-hour WMG compared to placebo and MK-0893 will be sufficiently well-tolerated to permit continued clinical development for use to treat patients with type 2 diabetes. | — |
Countries
Germany
Outcome results
None listed