Addition of Omarigliptin (MK-3102) to Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Combination Therapy With Glimepiride and Metformin (MK-3102-022)
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Omarigliptin; Matching placebo to Omarigliptin; Glimepiride; Metformin
Intervention description: Omarigliptin 25 mg capsule administered orally once a week; Matching placebo to omarigliptin capsule administered orally once a week; Open-label glimepiride tablet(s) administered orally once daily for a total daily dose >=4 mg. In the event of hypoglycemia, the glimepiride dose may be down-titrated to a minimum dose of 1 mg daily.; Open-label metformin tablet(s) administered orally once or twice daily for a total daily dose >=1500 mg
Intervention MeSH terms: Metformin; Glimepiride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 307.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will examine the safety and efficacy of the addition of omarigliptin in
      participants with type 2 diabetes mellitus with inadequate glycemic control on metformin and
      glimepiride. The primary hypothesis is that after 24 weeks, the addition of treatment with
      omarigliptin provides a greater reduction in hemoglobin A1c (A1C) compared with the addition
      of placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosed with type 2 diabetes mellitus

          -  Currently taking stable doses of metformin (>=1500 mg/day) and sulfonylurea

          -  Male, or female not of reproductive potential or female of reproductive potential who
             agrees to remain abstinent or use (or have their partner use) 2 methods of acceptable
             contraception to prevent pregnancy during the study and for 21 days after the last
             dose of study drug

        Exclusion Criteria:

          -  History of type 1 diabetes mellitus or a history of ketoacidosis

          -  Treated with any antihyperglycemic agent therapies other than the protocol-required
             sulfonylurea and metformin within 12 weeks prior to study participation or with
             omarigliptin at any time prior to study participation.

          -  History of hypersensitivity to a dipeptidyl peptidase IV (DPP-4) inhibitor

          -  On a weight loss program and is not in the maintenance phase; or has been on a weight
             loss medication in the past 6 months; or has undergone bariatric surgery within 12
             months prior to study participation.

          -  Is on or likely to require treatment for >=2 consecutive weeks or repeated courses of
             corticosteroids (inhaled, nasal or topical corticosteroids are permitted)

          -  Currently being treated for hyperthyroidism or is on thyroid replacement therapy and
             has not been on a stable dose for at least 6 weeks

          -  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

          -  Poorly controlled hypertension

          -  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

          -  Current user of recreational or illicit drugs or has had a recent history of drug
             abuse or routinely consumes >2 alcoholic drinks per day or >14 drinks per week, or
             engages in binge drinking

          -  Donated blood products within 8 weeks of study participation, or intends to donate
             blood products during the study or has received or anticipates receiving blood
             products within 12 weeks prior to study participation or during the study