A study to evaluate the safety, tolerability and efficacy of the addition of a new drug (MK-3102) in patients with Type 2 Diabetes who are already taking Metformin (licensed drug)
- Conditions
- Type 2 Diabetes MellitusMedDRA version: 18.0Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disordersTherapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Registration Number
- EUCTR2012-003670-11-HU
- 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. Note: For India only: Subject has T2DM and is =18 and =65 years of age on day of signing informed consent.
2. Subject is on metformin monotherapy at a stable dose of metformin (=1500 mg/day) for at least 12 weeks and has an A1C =7% (53 mmol/mol) and =10.5% (91 mmol/mol).
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 a hysterectomy and/or bilateral oophorectomy, or had bilateral tubal ligation at least 6 weeks prior to screening.
c. Subject is a female of reproductive potential and:
1) Agrees to remain abstinent from heterosexual activity (this form of birth control must be accepted by local regulatory agencies and ethics review committees as the sole method of birth control).
OR
2) Agrees to use (or her partner to use) acceptable contraception to prevent pregnancy within the projected duration of the trial and for 21 days after the last dose of blinded study medication. Two methods of contraception will be used to avoid pregnancy. Acceptable combinations of methods include:
- Use of one of the following double-barrier methods: diaphragm with spermicide and a condom; cervical cap and a condom; or contraceptive sponge and a condom.
- Use of hormonal contraception (any registered and marketed contraceptive agent that contains an estrogen and/or a progestational agent [including oral, subcutaneous, intrauterine and intramuscular agents, and cutaneous patch]) with one of the following: diaphragm with spermicide; cervical cap; contraceptive sponge; condom; vasectomy; or intrauterine device (IUD).
- Use of an IUD with one of the following: condom; diaphragm with
spermicide; contraceptive sponge; vasectomy; or hormonal contraception (see above).
- Vasectomy with one of the following: diaphragm with spermicide;
cervical cap; contraceptive sponge; condom; IUD; or hormonal
contraception (see 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 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:
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
1. Subject has a history of T1DM or a history of ketoacidosis OR Subject is assessed by the investigator as possibly having T1DM confirmed with a C-peptide <0.7 ng/mL (0.23 nmol/L).
2. Subject has been treated with any AHA therapies other than the protocol-required metformin within the prior 12 weeks of Visit 1/Screening or with MK-3102 at any time prior to signing informed consent.
3. Subject has a history of hypersensitivity to a DPP-4 inhibitor.
4. Subject is currently participating, or has participated in a trial in which the subject received an investigational compound or used an investigational device within the prior 12 weeks of signing the ICF
5. Subject has a history of intolerance, hypersensitivity, or any other contraindication to metformin, glimepiride, or insulin glargine based upon the label in the country of the investigational site.
6. Subject is on a weight loss program and is not in the maintenance phase; has been on a weight loss medication in the past 6 months; or has undergone bariatric surgery within 12 months prior to signing the informed consent.
7. Subject 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 =14 consecutive days or repeated courses of pharmacologic doses of corticosteroids.
9. Subject is currently being treated for hyperthyroidism or subject is on thyroid replacement therapy and has not been on a stable dose for at least 6 weeks.
10. Subject is currently on or likely to require treatment with a prohibited medication
11. Subject 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 blinded study medication.
12. Subject has a medical history of active liver disease (other than non-alcoholic hepatic steatosis)
13. Subject has HIV as assessed by medical history.
14. Subject has had new or worsening signs or symptoms of coronary heart disease or congestive heart failure within the past 3 months
15. Subject has poorly controlled hypertension defined as systolic blood pressure of =160 mm Hg or diastolic blood pressure of =90 mm Hg and blood pressure is unlikely to be within these limits by Visit 2/Week -2 with an adjustment in antihypertensive medication.
16. Subject 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. Subject has a clinically important hematological disorder
18. Subject has exclusionary laboratory values as listed in in the protocol.
19. Subject has a positive urine pregnancy test.
20. Subject is pregnant or breast-feeding, or is expecting to conceive during the trial, including 21 days following the last dose of blinded study medication.
21. Subject is, at the time of signing ICF a user of recreational or illicit drugs or has had a recent history of drug abuse.
22. Subject routinely consumes >2 alcoholic drinks per day or >14 alcoholic drinks per week, or engages in binge drinking.
23. Subject has a history or current evidence of any condition, therapy, laboratory abnormality or other circumstance that makes participation not in the subject’s best interest.
24. Subject 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
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