Type 2 Diabetes Mellitus MedDRA version: 16.1 Level: PT Classification code 10067585 Term: Type 2 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Interventions
Product Name: MK-3102
Product Code: MK-3102
Pharmaceutical Form: Capsule
INN or Proposed INN: Omarigliptin
Current Sponsor code: MK-3102
Concentration unit: mg milligram(s)
Concentration type: equal
Sponsors
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subject has T2DM and must be =18 of age on the day of signing the informed consent form. For India: subject has T2DM and is =18 and =65 years of age. 2. Subject is on a stable dose of metformin (=1500 mg/day) for at least 12 weeks with inadequate glycemic control, i.e., A1C =6.5% (48 mmol/mol) and =9.0%.% (75 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: (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. 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). AND Subject has 85% compliance with glimepiride placebo treatment during the singleblind 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 646 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 34
Exclusion criteria
Exclusion criteria: 1. Subject has a history of T1DM or a history of ketoacidosis. OR is assessed by the investigator as possibly having T1DM confirmed with a C-peptide 2 alcoholic drinks per day or >14 alcoholic drinks per week, or engages in binge drinking. 21. Subject has a history or current evidence of any condition, therapy, lab abnormality or other circumstance that makes participation not in the subject’s best interest 22. Subject has donated blood products or has had phlebotomy of >300 mL within 8 weeks of signing ICF. 2
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: After 54 weeks, to assess the A1C-lowering efficacy of MK-3102 compared to glimepiride. To assess the safety and tolerability of MK-3102.;Secondary Objective: After 54 weeks, to assess the effect of the addition of MK-3102 compared with glimepiride on the incidence of symptomatic hypoglycemia. After 54 weeks, to assess the effect of the addition of MK-3102 compared with glimepiride on gain in body weight from baseline. After 54 weeks, to assess the effect of the addition of MK-3102 compared with glimepiride on fasting plasma glucose (FPG). After 54 weeks, to assess the effect of the addition of MK-3102 compared with glimepiride on proportion of subjects achieving an A1C goal (0.5% with no symptomatic hypoglycemia and no body weight gain.;Primary end point(s): Change from baseline in A1C ;Timepoint(s) of evaluation of this end point: Week 54 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Change from baseline in FPG - Proportion of subjects achieving the goal A1C <6.5% (48 mmol/mol), <7.0% (53 mmol/mol) at Week 54 - Proportion of subjects with AE of symptomatic hypoglycemia up to Week 54; - Change from baseline in body weight at Week 54. ;Timepoint(s) of evaluation of this end point: Week 54 | — |
Countries
Argentina, Croatia, European Union, Germany, Hungary, India, Israel, Jordan, Korea, Republic of, Lebanon, Lithuania, Malaysia, Mexico, Poland, Russian Federation, United States
Contacts
Public ContactGlobal Clinical Trials Operations
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Outcome results
None listed