Type 2 Diabetes Mellitus MedDRA version: 7.0 Level: LLT Classification code 10045242
Conditions
Interventions
Product Name: MK-0431
Product Code: L-000224715
Pharmaceutical Form: Tablet
Other descriptive name: L-000224715
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Sponsors
Merck & Co., Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who meet the criteria listed below will be recruited for enrollment into the study. All laboratory measurements are to be performed after an overnight fast =12 hours in duration. a. Patient has type 2 diabetes mellitus (T2DM). b. Patient is =18 and =78 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, as indicated by at least one “yes” answer to the following questions: 1) Patient is a male. 2) Patient is a surgically sterilized female. 3) Patient is a postmenopausal female =45 years of age with >2 years since last menses. 4) Patient is a non-sterilized premenopausal female and agrees to: (1) use 2 adequate methods of contraception to prevent pregnancy (either 2 barrier methods or a barrier method plus a hormonal contraceptive method) or (2) abstain from heterosexual activity throughout the study starting with Visit 1 and for 14 days after the last dose of study medication. Refer to Section I.E.12.a. for description of acceptable methods of contraception. f. Patient meets one of the following criteria as indicated by a “yes” answer to one of the following: 1) Patient is currently not on an antihyperglycemic agent (off therapy for =8 weeks) and has a Visit 1/Screening Visit HbA1c =7.5% and =11%. OR Patient is in 1 of the following 3 categories AND based upon review of the patient’s current diet, medical regimen, and Visit 1/Screening Visit HbA1c, patient is considered by the investigator to be likely to meet Visit 3 inclusion criterion of HbA1c =7.5% to =11% with diet/exercise counseling: 2) Patient is currently not on an antihyperglycemic agent (off therapy for =8 weeks) and has a Visit 1/Screening Visit HbA1c >11%. 3) Patient is currently on antihyperglycemic agent monotherapy or dual oral combination therapy and has a Visit 1/Screening Visit HbA1c =7% and =10%. 4) Patient is currently on dual oral combination therapy (which contains at least one agent dosed at >50% maximal labeled dose), has Visit 1/Screening Visit HbA1c =6.5% and =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: see the protocol for comprehensive list and additional clarification. a. Patient has a history of type 1 diabetes or ketoacidosis. b. Patient required insulin within the prior 8 weeks. c. Patient has an hypersensitivity contraindication to biguanide medication. d. Patient has a serum ALT or AST >2.0-fold the Upper Limit of Normal. Note: Patients whose serum ALT or AST exceeds this limit may be retested one time if the investigator does not believe the value reflects the patient’s clinical status. e. Serum creatinine 123.8 µmol/L in men and 114.9 µmol/L in women or estimated creatinine clearance (using Cockcroft-Gault formula) 270 mg/dL (14.99 mmol/L) and is not considered likely to improve glycemic control with diet and exercise counseling.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: After 24 weeks: (1) To assess the effect of co-administration of MK-0431 and metformin compared with the effect of metformin monotherapy on HbA1c; (2) To assess the effect of co-administration of MK-0431 and metformin compared with the effect of MK-0431 monotherapy on HbA1c; (3) To assess the safety and tolerability of co-administration of MK-0431 and metformin, MK-0431 monotherapy, and metformin monotherapy, including the incidence of selected gastrointestinal adverse events (i.e., abdominal pain, nausea, vomiting, and diarrhea). ;Secondary Objective: See Protocol-036 for the secondary objectives. ;Primary end point(s): HbA1c | — |
Countries
Hungary, Lithuania, Norway, United Kingdom
Outcome results
None listed