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: 15.1Level: 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-ES
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 500
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% and ?10.5%.
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:
1) 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
2) Agrees to use (or her partner to use) adequate contraception to prevent pregnancy within the projected duration of the trial and for 21 days after the last dose of blinded study medication. Adequate methods of contraception include:
- Use of 2 barrier methods. Acceptable barrier methods include diaphragm with spermicide, cervical cap, contraceptive sponge, and condom.
- Use of an intrauterine device (IUD) and one of the barrier methods identified above.
- Use of an appropriate hormonal contraception and one of the barrier methods identified above. Appropriate hormonal contraceptives include 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.
- Vasectomy and a single barrier method.
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 475
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25
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.
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 or has started a weight loss medication 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 the projected duration of the trial OR subject has received, or is anticipated to receive, blood product
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: - After 24 weeks, to assess the effect of the addition of treatment with MK- 3102 compared to placebo on A1C.<br><br>- To assess the safety and tolerability of MK-3102.;Secondary Objective: - After 24 weeks, to assess the effect of the addition of treatment with MK-3102 compared to placebo on 2-hour post-meal glucose (2-hour PMG) after a standard meal challenge.<br><br>- After 24 weeks, to assess the effect of the addition of treatment with MK-3102 compared to placebo on fasting plasma glucose (FPG).<br><br>- After 104 weeks, to assess the effect of the addition of treatment with MK-3102 on (1) A1C; (2) FPG; and (3) the durability of glycemic efficacy.;Primary end point(s): Change from baseline in A1C at Week 24.;Timepoint(s) of evaluation of this end point: Week 24
- Secondary Outcome Measures
Name Time Method Secondary end point(s): - Change from baseline in 2-hour PMG at Week 24;<br>- Change from baseline in FPG at Week 24.<br>- Change from baseline in A1C at Week 104;<br>- Change from baseline in FPG at Week 104; <br>- Proportion of subjects attaining A1C glycemic goals of <7% and <6.5% after 24 and 104 weeks of treatment;<br>- Change from baseline in post-meal glucose total AUC at Week 24;<br>- Change from baseline in fasting insulin at Week 24 and Week 104;<br>- Time to rescue over 24 and 104 weeks;<br>- Proportion of subjects requiring rescue therapy at Week 24 and 104.<br>- Safety Endpoints;Timepoint(s) of evaluation of this end point: Weeks 24 and 104