A Study to Evaluate the Safety and Efficacy of Omarigliptin (MK-3102) Compared With Glimepiride in Participants With Type 2 Diabetes Mellitus for Whom Metformin is Inappropriate (MK-3102-027)
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Omarigliptin; Glimepiride; Omarigliptin Placebo; Glimepiride Placebo
Intervention description: Omarigliptin (MK-3102) 25 mg capsule administered orally once weekly; Glimepiride tablet 1 mg and/or 2 mg (uptitrated to a maximum dose 6 mg/day) administered orally once daily with breakfast or the first main meal; Matching placebo to omarigliptin capsule administered orally once weekly; Matching placebo to glimepiride tablet administered orally once daily with breakfast or the first main meal
Intervention MeSH terms: Glimepiride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 65.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This trial will assess the safety and efficacy of omarigliptin (MK-3102) compared with the
      sulfonylurea, glimepiride, in type 2 diabetes mellitus participants who are metformin
      intolerant or who have a contraindication to the use of metformin. The primary hypothesis is
      that after 54 weeks, the mean change from baseline in hemoglobin A1c (A1C) in participants
      treated with omarigliptin is non-inferior compared with that in participants treated with
      glimepiride.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosed with type 2 diabetes mellitus

          -  Have intolerability to metformin ≥1000 mg/day or have a contraindication to the use of
             metformin

          -  Females of reproductive potential agree to remain abstinent or use or have their
             partner use 2 acceptable methods of birth control

        Exclusion Criteria:

          -  History of type 1 diabetes mellitus or a history of ketoacidosis or assessed by the
             investigator as possibly having type 1 diabetes

          -  Has been treated with:

               1. A thiazolidinedione (TZD) within 4 months of study participation, or

               2. A glucagon-like peptide-1 (GLP-1) receptor mimetic or agonist (such as exenatide
                  or liraglutide) within 6 months of study participation, or

               3. Insulin within 12 weeks prior to study participation, or

               4. Dual antihyperglycemic agent (AHA) therapy within 12 weeks of study participation
                  (4 months if a component of the dual AHA therapy was a TZD)

               5. Omarigliptin (MK-3102) at any time prior to study participation

          -  On a weight loss program and is not in the maintenance phase; has started a weight
             loss medication in the past 6 months; or has undergone bariatric surgery within 12
             months prior to study participation

          -  Medical history of active liver disease (other than non-alcoholic hepatic steatosis),
             including chronic active hepatitis B or C, primary biliary cirrhosis, or symptomatic
             gallbladder disease

          -  Human immunodeficiency virus (HIV)

          -  New or worsening coronary heart disease, congestive heart failure, myocardial
             infarction, unstable angina, coronary artery intervention, stroke or transient
             ischemic neurological disorder within the past 3 months

          -  History of malignancy ≤5 years prior to study participation except for adequately
             treated basal cell or squamous cell skin cancer, or in situ cervical cancer

          -  Clinically important hematological disorder (such as aplastic anemia,
             myeloproliferative or myelodysplastic syndromes, thrombocytopenia)

          -  Pregnant or breast-feeding, or is expecting to conceive or donate eggs during the
             trial, including 21 days following the last dose of study drug