Type 2 Diabetes Mellitus MedDRA version: 7.0 Level: LLT Classification code 10045242
Conditions
Sponsors
Merck & Co., Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: a. Patient has type 2 diabetes mellitus (T2DM). b. Patient is ?18 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 ?7% and ?10% 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 >1.7 mg/dL (150.3 µmol/L) in men and >1.6 mg/dL ( 141.4 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 pioglitazone at a dose of 30 mg/day or 45 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 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 fasting plasma glucose (FPG).;Primary end point(s): HbA1c | — |
Countries
Denmark, Hungary, Italy, Lithuania
Outcome results
None listed