A study to evaluate the safety and efficacy of the addition of a new drug (MK-3102) compared with the addition of a licensed drug Glimepiride) in patients with Type 2 Diabetes.
- Conditions
- Type 2 Diabetes MellitusMedDRA version: 16.0Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disordersTherapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Registration Number
- EUCTR2013-000301-23-ES
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 680
1. Have T2DM and be >/=18 years of age on the day of signing the informed consent form.
2. Have intolerability to metformin >/=1000 mg/day and meet one of the following criteria:
a. Subject is currently not on an AHA medication (off for >/=12 weeks) and has a Visit 1/Screening A1C >/=7.0% (53 mmol/mol) and b. Subject is on monotherapy with any sulfonylurea, daily DPP-4 inhibitor or SGLT2 inhibitor with an A1C >/=6.5% (48 mmol/mol) and c. Subject is on <1000 mg/day metformin as monotherapy with an A1C >/=6.5% (48 mmol/mol) and OR
Have a contraindication to the use of metformin and meet one of the following criteria:
a. Subject is currently not on an AHA medication (off for >/=12 weeks) and has a Visit 1/Screening A1C >/=7.0% (53 mmol/mol) and b. Subject is on monotherapy with any sulfonylurea, daily DPP-4 inhibitor or SGLT2 inhibitor with an A1C >/=6.5% (48 mmol/mol) and
3. Meet 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:
(1) reached natural menopause (defined as >/=12 months of spontaneous amenorrhea in women >45 years of age, or >/=6 months of spontaneous amenorrhea with serum follicular stimulating hormone [FSH] levels in the postmenopausal range as determined by the laboratory), or
(2) had a hysterectomy and/or bilateral oophorectomy, or had bilateral tubal ligation or occlusion at least 6 weeks prior to screening.
c. Subject is a female of reproductive potential and:
(1) agrees to remain abstinent from heterosexual activity (if this form of birth control is accepted by local regulatory agencies and ethics review committees as the sole method of birth control), or
(2) agrees to use (or have their partner 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. Understand 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. Must be 100% compliant with MK-3102 placebo treatment during the single-blind run-in period (as determined by site-performed capsule count).
AND
Subject has 85% compliance with glimepiride placebo treat
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 TZD within 4 months of signing informed consent, or
b. a GLP-1 receptor mimetic or agonist (such as exenatide or liraglutide) within 6 months of signing informed consent, or
c. insulin within 12 weeks prior to signing informed consent, or
d. has been treated with dual AHA therapy within 12 weeks of signing informed consent (4 months if a component of the dual AHA therapy was a TZD)
e. MK-3102 at any time prior to signing informed consent.
3. Has a history of hypersensitivity to a DPP-4 inhibitor.
4. Is currently participating in, 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 informed consent or is not willing to refrain from participating in any other trial.
5. Has a history of intolerance or hypersensitivity to glimepiride or any contraindication to glimepiride 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; 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. Has undergone a surgical procedure within 4 weeks prior to signing informed consent or has planned major surgery during the trial.
8. Is on or likely to require treatment for >/=14 consecutive days or repeated courses of pharmacologic doses of corticosteroids.
9. 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. (see Section 5.5.2 for a list of prohibited medications).
10. Is currently on or likely to require treatment with a prohibited medication Concomitant Disease of Organs and Systems
11. Has a medical history of active liver disease (other than non-alcoholic hepatic steatosis), including chronic active hepatitis B or C (assessed by medical history), primary biliary cirrhosis, or symptomatic gallbladder disease.
12. Has human immunodeficiency virus (HIV) as assessed by medical history.
13. 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 (e.g., myocardial infarction or unstable angina),
b. Coronary artery intervention (e.g., coronary artery bypass grafting or percutaneous transluminal coronary angioplasty),
c. Stroke or transient ischemic neurological disorder.
14. 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 below these limits by Visit 3/Week -2 with an adjustment in antihypertensive medication.
15. Has a history of malignancy
16. Has a clinically important hematological disorder (such as aplastic anemia, myeloproliferative or myelodysplastic syndromes, thrombocytopenia).
17. Has a positive urine pregnancy test.
18. Is pregnant or breast-feeding, or is expecting to conceive during the trial, including 21 days
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