Type 2 Diabetes Mellitus MedDRA version: 7.0 Level: LLT Classification code 10045242
Conditions
Sponsors
Merck Sharp & Dohme
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: a. Patient has type 2 diabetes mellitus (T2DM). b. Patient is greater than or equal to18 and less than or equal to78 years of age. c. Patient has an understanding of the study procedures and agrees to participate in the study by giving written informed consent. d. Patient is not pregnant or breast-feeding and does not plan to become pregnant for the duration of the study and poststudy follow-up period. e. Patient is a male, or a female who is highly unlikely to conceive f. HbA1c greater than or equal to 7% and less than or equal to10% measured at, or within 2 weeks prior to, Visit 3. 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: a. Patient has a history of type 1 diabetes mellitus or a history of ketoacidosis b. Patient has an ALT or AST >2.0-fold the Upper Limit of Normal (ULN) c. Serum creatinine greater than or equal to1.4 mg/dL (123.8 µmol/L) in men and greater than or equal to 1.3 mg/dL (114.9 µmol/L) in women or estimated creatinine clearance (using Cockcroft-Gault formula) 43 kg/m2 g. Patient has a positive urine pregnancy test h. Patient has any other condition or therapy which, in the opinion of the investigator or Merck medical monitor, might pose a risk to the patient or make participation not in the patient’s best interest. i. Patient has poor mental function or any other reason to expect that the patient may have difficulty in complying with the requirements of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Main objective : In patients with type 2 diabetes mellitus with inadequate glycemic control on metformin at a dose of greater than or equal to 1500 mg/day: (1) After 24 weeks, to assess the effect of the addition of treatment with MK-0431 compared with placebo on HbA1c; (2) To assess the safety and the tolerability of MK-0431.;Secondary Objective: Secondary objectives : After 24 weeks, to assess the effect of the addition of treatment with MK-0431 compared with placebo on: (1) fasting plasma glucose (FPG); (2) the plasma glucose profile after a standard meal challenge; (3) in a subset of patients undergoing more extensive blood sampling after a standard meal challenge: indices of insulin secretion derived from the C-peptide, insulin, and glucose profile. Over 104 weeks, to assess the effect of the addition of treatment of MK-0431 on: (4) HbA1c and FPG; (5) the durability of glycemic efficacy.;Primary end point(s): HbA1c | — |
Countries
Austria, Belgium, Denmark, Italy, Sweden
Outcome results
None listed