Type 2 Diabetes Mellitus MedDRA version: 7.0 Level: LLT Classification code 10045242
Conditions
Interventions
Product Name: sitagliptin
Product Code: MK-0431
Pharmaceutical Form: Tablet
Current Sponsor code: MK-0431
Other descriptive name: sitagliptin
Concentration unit: mg milligram(s)
Concentration type:
Sponsors
Merck Sharp & Dohme (Sweden) AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 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. At Visit 1 a) Patient has type 2 diabetes mellitus (T2DM). b) Patient is = 18 and = 75 years of age on the day of signing informed consent. c) Patient understands the study procedures, alternative treatments available, and risks involved with the study, and voluntarily agrees to participate by giving written informed consent. d) Patient is a male, or 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 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 method) or (2) to abstain from heterosexual activity throughout the study starting with Screening Visit/Visit 1 and for 14 days after the last dose of study medication. Refer to Section I.E.11.a. for description of acceptable methods of contraception. e) Patient meets one of the following criteria as indicated by a “yes” answer to one of the following: I. Patient is currently on monotherapy with metformin at a dose of = 1500 mg/day and has a Screening Visit/Visit 1 HbA1c = 7% and = 11%. 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: Product: MK-0431 Protocol/Amendment No.: 801-00 Approved 28 MK-0431 Approved 15-Mar-2006 Non-U.S.IND, Ex-U.S. Study Restricted Confidential – Limited Access 2. Exclusion Criteria At Visit 1 a) Patient participated in a sitagliptin trial (MK – 0431) and received treatment with sitagliptin or blinded therapy (actual treatment not yet known to investigator). b) Patient has presence of or a history of peripheral edema. c) Patient is currently participating or has participated in a study with an investigational compound or device within 12 weeks of signing informed consent or plans to participate and is not willing to refrain from participating in another study. Glucose Metabolism and Therapy Criteria d) Patient has a history of type 1 diabetes mellitus or a history of ketoacidosis. e) Patient required insulin within the prior 8 weeks. Patients Requiring Specific Treatments f) Hypersensitivity or contraindication to any thiazolidinedione (e.g., rosiglitazone or pioglitazone) or biguanide (e.g., metformin) medications. Note: Contraindication based upon the label of the country of the investigational site. g) Patient is following a weight loss program and is not in a weight-stable phase. h) Patient started on a weight loss medication (e.g., orlistat or sibutramine) within the prior 8 weeks or plans to initiate weight loss medication during the study. i) Patient is on or likely to require treatment with =14 consecutive days or repeated courses of pharmacologic doses of corticosteroids. j) Patient is on or likely to require an immunosuppressive/immunomodulating agent (e.g., cyclosporin, methotrexate, etanercept). k) Patient has undergone surgery requiring general anesthesia within the prior 30 days or patient has planned surgery.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: In patients with type 2 diabetes mellitus with inadequate glycemic control on metformin at a dose of at least 1500 mg/day: Primary: (1) After 18 weeks, to assess the effect of the addition of sitagliptin compared with placebo on HbA1c; (2) To assess the safety and the tolerability of sitagliptin compared with placebo. ;Secondary Objective: Secondary: (1) After 18 weeks, to assess the effect of the addition of sitagliptin compared with placebo on: fasting plasma glucose (FPG); (2) After 18 weeks, to assess the effect of the addition of sitagliptin compared with placebo on 2-hour plasma glucose after a standard meal challenge. (3) After 18 weeks, to estimate the difference in effect of the addition of sitagliptin and the addition of rosiglitazone on HbA1c (4) After 18 weeks, to estimate the difference in effect of the addition of sitagliptin and addition of rosiglitazone on body weight. (5) After 18 weeks to estimate the difference in effect of the addition of sitagliptin and the addition of rosiglitazone on LDL-C.;Primary end point(s): HbA1c | — |
Countries
Italy, Sweden
Outcome results
None listed