Type 2 Diabetes Mellitus MedDRA version: 7.0 Level: LLT Classification code 10045242
Conditions
Interventions
Product Name: MK-0431
Pharmaceutical Form: Tablet
Current Sponsor code: MK-0431
Other descriptive name: L-000224715
Concentration unit: mg/g milligram(s)/gram
Concentration type: up to
Concentration n
Sponsors
Merck & Co., Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: a. Patient has type 2 diabetes mellitus (T2DM). b. Patient is ?18 and ?75 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. Patient’s renal function is reflected below as indicated by a “yes” answer to one of the following: 1) Patient is a male = 65 years of age and serum creatinine >1.8 mg/dL (159.1 µmol/L). 2) Patient is a male > 65 years of age and serum creatinine >1.6 mg/dL (141.4 µmol/L). 3) Patient is a female = 65 years of age and serum creatinine >1.6 mg/dL (141.4 µmol/L). 4) Patient is a female > 65 years of age and serum creatinine >1.3 mg/dL (114.9 µmol/L). 5) Creatinine clearance is 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. 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. Patient’s renal function is reflected below as indicated by a “yes” answer to one of the following: 1) Patient is a male = 65 years of age and serum creatinine >1.8 mg/dL (159.1 µmol/L). 2) Patient is a male > 65 years of age and serum creatinine >1.6 mg/dL (141.4 µmol/L). 3) Patient is a female = 65 years of age and serum creatinine >1.6 mg/dL (141.4 µmol/L). 4) Patient is a female > 65 years of age and serum creatinine >1.3 mg/dL (114.9 µmol/L). 5) Creatinine clearance is 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 diet and exercise: (1) After 24 weeks, to assess the effect 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 treatment with MK-0431 compared with placebo on: (1) fasting plasma glucose (FPG) and fructosamine; and (2) the plasma glucose profile after a standard meal challenge. Over 104 weeks, to assess the effect of treatment with MK-0431 on: (3) HbA1C and FPG; (4) the durability of glycemic efficacy; (5) 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. (6) In a subset of patients undergoing intravenous glucose tolerance testing: indices of insulin secretion derived from the C-peptide, insulin, and glucose profile.;Primary end point(s): 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. Patient’s renal function is reflected below as indicated by a “yes” answer to one of the following: 1) Patient is a male = 65 years of age and serum creatinine >1.8 mg/dL (159.1 µmol/L). 2) Patient is a male > 65 years of age and serum creatinine >1.6 mg/dL (141.4 µmol/L). 3) Patient is a female = 65 years of age and serum creatinine >1.6 mg/dL (141.4 µmol/L). 4) Patient is a female > 65 years of age and serum creatinine >1.3 mg/dL (114.9 µmol/L). 5) Creatinine clearance is 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 t | — |
Countries
Hungary, United Kingdom
Outcome results
None listed