A Phase 3 study in Patients with Type 2 Diabetes Mellitus
- Conditions
- Type 2 Diabetes MellitusMedDRA version: 14.1Level: HLTClassification code 10012602Term: Diabetes mellitus (incl subtypes)System Organ Class: 100000004860Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Registration Number
- EUCTR2012-003626-24-IT
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 400
1. Subject has T2DM and must be =18 years of age on the day of signing the informed consent form. 2. Subject meets one of the following criteria: a. Subject is currently not on an AHA (off AHA therapies for =12 weeks) and has a Visit 1/Screening Visit A1C =7.0 and =10.0%. b. Subject is currently on a stable dose for > 12 weeks of a single AHA or low-dose dual oral AHA combination therapy (i.e., =50% maximum labeled dose of each agent [except thiazolidinediones (TZDs)]) and has a Visit 1/ Screening Visit A1C =6.5 and =9.0% AND based upon review of the subject's current diet, medical regimen, and Visit 1 A1C, subject is considered by the investigator to be likely to meet Visit 3/Week -2 inclusion criterion of A1C =7.0 and = 10.0% AFTER the 8-week wash-off period prior to Visit 3/Week-2 (Visit 2/Week -10 to Visit 3/ Week -2). 3. Subject meets one of the following criteria: a. Subject is a male b. Subject is a female not of reproductive potential defined as one who has either • reached natural menopause (defined as =12 months of spontaneous amenorrhea in women >45 years of age, or =6 months of spontaneous amenorrhea with serum FSH levels in the postmenopausal range as determined by the laboratory), or • had bilateral oophorectomy and/or hysterectomy, or had bilateral tubal ligation at least 6 weeks prior to screening c. Subject is a female of reproductive potential and agrees to: • remain abstinent from heterosexual activity (this form of birth control must be accepted by local regulatory agencies and review committees as the sole method of birth control), or • use (or have their partner use) adequate contraception to prevent pregnancy within the projected duration of the trial and for 21 days after the last dose of trial medication. Adequate methods of contraception include: - use of 2 barrier methods. Acceptable barrier methods are: diaphragm with spermicide, cervical cap, contraceptive sponge, condom - use of an IUD and one of the barrier methods identified above - vasectomy in a male partner and use of one of the barrier methods identified above 4. Subject understands the trial procedures, alternative treatments available, and risks involved with the trial, and voluntarily agrees to participate by giving written informed consent. The subject may also provide consent for Future Biomedical Research. However, the subject may participate in the main trial without participating in Future Biomedical Research. 5. Subject has an A1C of =7.0% and =10.0% within 2 weeks of Visit 3/Week -2. Note: If the A1C is not within the Visit 3 A1C inclusion criterion, a single repeat measurement maybe performed at the discretion of the investigator. If repeat value meets Visit 3 A1C inclusion criterion, subject may continue in the trial. 6. Subject has 100% compliance with MK-3102 placebo treatment during the single-blind run-in period (as determined by site-performed capsule count).
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 380
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20
Subject 1. has a history of type 1 diabetes mellitus or a history of ketoacidosis or Subject is assessed by the investigator as possibly having type 1 diabetes confirmed with a C-peptide <0.7 ng/mL (0.23 nmol/L) 2. has been treated with: a. a thiazolidinedione (TZD) within 4 months of signing informed consent, or b. a GLP-1 receptor mimetic or agonist or DPP-4 inhibitors within 6 months of signing informed consent, or c. insulin within 12 weeks prior to signing informed consent 3. has a history of hypersensitivity to a DPP-4 inhibitor 4. is currently participating in/has participated in another trial with an investigational compound or device within the prior 12 weeks of signing the informed consent and does not agree to refrain from participating in any other trial 5. has a history of intolerance, hypersensitivity or any contraindication to metformin, glimepiride or other sulfonyurea based upon the label in the country of the investigational site. 6. is on a weight loss program and is not in the maintenance phase or has started a weight loss medication or has undergone bariatric surgery within 12 months prior to signing the informed consent 7. has undergone a surgical procedure within 4 weeks prior to signing informed consent or has planned major surgery during the trial 8. Subject is on or likely to require treatment for =2 consecutive weeks or repeated courses of pharmacologic doses of corticosteroids 9. is currently being treated for hyperthyroidism or subject is on thyroid hormone therapy and has not been on a stable dose for at least 6 weeks 10. is currently on or likely to require treatment with a prohibited medication 11. is expecting to undergo hormonal therapy in preparation to donate eggs during the period of the trial, including 21 days following the last dose of trial medication. 12. has a medical history of active liver disease, including chronic active hepatitis B or C, primary biliary cirrhosis, or symptomatic gallbladder disease. 13. has HIV as assessed by medical history. 14. has had new or worsening signs or symptoms of coronary heart disease or congestive heart failure within the past 3 months, or has any of the following disorders within the past 3 months: a. Acute coronary syndrome b. Coronary artery intervention c. Stroke or transient ischemic neurological disorder 15. has poorly controlled hypertension defined as systolic blood pressure of =160 mm Hg or diastolic blood pressure of =90 mm Hg 16. has a history of malignancy =5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer 17. has a clinically important hematological disorder 18. has exclusionary laboratory values (as per protocol) 19. has a positive urine pregnancy test 20. is pregnant or breast-feeding, or is expecting to conceive during the trial, including 21 days following the last dose of trial medication. 21. is a user of recreational or illicit drugs or has had a recent history of drug abuse 22. routinely consumes >2 alcoholic drinks per day or >14 alcoholic drinks per week, or engages in binge drinking. 23. has a history or current evidence of any condition that makes participation not in the subject's best interest 24. has donated blood products or has had phlebotomy of >300 mL within 8 weeks of signing informed consent, or intends to donate blood products within the projected duration of the trial OR subject has received, or is anticipated to receive,
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method