A Study of the Safety and Efficacy of Omarigliptin (MK-3102) Compared With Glimepiride in Participants With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin (MK-3102-016)
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Omarigliptin; Placebo to Omarigliptin; Glimepiride; Glimepiride Placebo; Metformin; Insulin Glargine
Intervention description: Glimepiride (1 mg and/or 2 mg tablets). During the 54-week double-blind treatment period, glimepiride can be up-titrated, as appropriate, to a maximum total daily dose of 6 mg/day. Throughout the trial, down-titration of glimepiride may also occur based upon the participant's glucose measurements and clinical symptoms of hypoglycemia.; Participants will continue on their stable dose (>=1500 mg/day) of open-label metformin throughout the trial.; Insulin glargine can be used for rescue therapy, if glycemic control is not maintained. Insulin therapy should be initiated as per local country insulin glargine label.
Intervention MeSH terms: Metformin; Insulin Glargine; Glimepiride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 751.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: diabetes

Summary:

      This trial will assess the safety and efficacy of omarigliptin (MK-3102) compared with the
      sulfonylurea, glimepiride, in Type 2 diabetes mellitus participants with inadequate glycemic
      control on metformin monotherapy. The primay hypothesis of the study 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

          -  On a stable dose of metformin (≥1500 mg/day) for at least 12 weeks with inadequate
             glycemic control

          -  Females of reproductive potential agree to remain abstinent or use or have their
             partner use acceptable methods of birth control

        Exclusion Criteria:

          -  History of type 1 diabetes mellitus or a history of ketoacidosis

          -  Treated with any antihyperglycemic agents (AHA) therapies other than the
             protocol-required metformin within the prior 12 weeks of study participation or with
             omarigliptin at any time prior to signing informed consent

          -  On a weight loss program and is not in the maintenance phase or 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

          -  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