Type 2 Diabetes Mellitus MedDRA version: 7.0 Level: LLT Classification code 10045242
Conditions
Sponsors
Merck Sharp & Dohme Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 036 BASE STUDY: 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 <7%, and has been approved by the Merck clinical monitor. NOTE: Patients currently not on an antihyperglycemic agent, but off therapy for <8 weeks, may be enrolled following discussion with and approval by the Merck Clinical Monitor. g. HbA1c =7.5% and =11% measured at Visit 3. NOTE: Once a patient has initiated placebo run-in at Visit 3, if the Visit 3 HbA1c is not within the Visit 3 HbA1c inclusion criterion, a single repeat measurement may be performed at the discretion of the investigator. If repeat value meets Visit 3 HbA1c inclusion criterion, patient may continue in study. h. Patient has =75% compliance (as measured by tablet count) with placebo treatment during run-in. 036 EXTENSION STUDY: All laboratory measurements are to be performed after an overnight fast =12 hours in duration. At
Exclusion criteria
Exclusion criteria: 036 BASE STUDY See the BASE STUDY 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. 036 EXTENSION STUDY At Visit 14 a. Patient has developed any medical condition or disorder that, in the opinion of the investigator or Merck Clinical Monitor, might pose a risk to the patient or would make the use of metformin contraindicated based upon the product label in that country (refer to Appendix 11). b. Patient is on or likely to require an excluded medication (ie. Non-study antihyperglycemic medication, immunosuppressive/immunomodulating agent, etc. (See Appendix 1).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): HbA1c;Secondary Objective: See base study and extension Protocols-036 for the secondary objectives. ; Main Objective: After 24 weeks (036 base study), After 104 weeks (036 extension study): (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). | — |
Countries
Hungary, Lithuania, Norway, United Kingdom
Outcome results
None listed