A Study to Assess the Safety and Efficacy of Omarigliptin (MK-3102) in Participants With Type 2 Diabetes Mellitus (T2DM) and Inadequate Glycemic Control (MK-3102-011)
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Omarigliptin; Placebo to Omarigliptin; Metformin; Placebo to metformin; Glimepiride
Intervention description: Omarigliptin 25 mg capsule administered orally once a week.; Placebo to omarigliptin capsule administered orally once a week; If necessary, participants may have glycemic rescue therapy initiated with open-label metformin during Phase A of the study. Participants in the placebo treatment group who were not rescued with open-label metformin during Phase A will receive blinded metformin (starting at 500 mg orally twice daily with up-titration to 1000 mg orally twice daily) in Phase B. Participants in the omarigliptin treatment group who were rescued with open-label metformin in Phase A will continue open-label metformin during Phase B of the study.; During Phase B of the study, participants in the omarigliptin treatment group who did not initiate glycemic rescue therapy during Phase A will receive placebo to metformin for 30 weeks (Phase B of the study).; If necessary during Phase B of the study, participants will initiate open-label glimepiride as glycemic rescue therapy
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: 329.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the safety and efficacy of omarigliptin (MK-3102),
      dosed once-weekly in participants with T2DM who have inadequate glycemic control on diet and
      exercise. The primary hypothesis is that after 24 weeks, treatment with omarigliptin compared
      with placebo provides greater reduction in hemoglobin A1c (A1C).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has type 2 diabetes mellitus

          -  Participants in India must be ≤65 years of age

          -  Meets one of the following criteria: currently not on an antihyperglycemic agent (AHA)
             for >= 12 weeks and has an A1C of >=7% and <=10% or on stable AHA monotherapy or
             low-dose combination therapy for > 12 weeks and has an A1C of >=6.5% and <=9%

          -  Participant is one of the following: male, female who is not of reproductive
             potential, female of reproductive potential who agrees to remain abstinent from
             heterosexual activity or use (or have their partner use) 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

          -  Has been treated with: a thiazolidinedione (TZD) within 4 months of study
             participation, a glucagon-like peptide-1 (GLP-1) receptor mimetic or agonist or
             dipeptidyl peptidase IV (DPP-4) inhibitor within 6 months of study participation,
             insulin or sodium-glucose cotransporter inhibitor within 12 weeks of study
             participation, omarigliptin at any time prior to study participation

          -  History of hypersensitivity to DPP-4 inhibitor

          -  History of intolerance, hypersensitivity or any contraindication to metformin and/or
             glimepiride or other sulfonylurea

          -  Is on a weight loss program and 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

          -  Has undergone a surgical procedure within 4 weeks of study participation or has
             planned major surgery during the study

          -  Is on or likely to require treatment for ≥14 consecutive days or repeated courses of
             corticosteroids (inhaled, nasal and topical corticosteroids are permitted)

          -  Is currently being treated for hyperthyroidism or is on thyroid hormone therapy and
             has not been on a stable dose for at least 6 weeks

          -  Is expecting to undergo hormonal therapy in preparation to donate eggs during the
             study, including 21 days following the last dose of study drug

          -  History of active liver disease (other than non-alcoholic steatosis) including chronic
             active hepatitis B or C, primary biliary cirrhosis, or symptomatic gallbladder disease

          -  Human immunodeficiency virus (HIV)

          -  Has had new or worsening coronary heart disease or congestive heart failure within the
             past 3 months, or has any of the following disorders within the past 3 months: acute
             coronary syndrome, coronary artery intervention, stroke or transient ischemic
             neurological disorder

          -  Has poorly controlled hypertension

          -  History of malignancy <=5 years prior to study participation, except for basal cell or
             squamous cell skin cancer or in situ cervical cancer

          -  Hematological disorder (such as aplastic anemia, myeloproliferative or myelodysplastic
             syndromes, thrombocytopenia)

          -  Pregnant or breastfeeding, or is expecting to conceive during the study, including 21
             days following the last dose of study drug

          -  User of recreational or illicit drugs or has had a recent history of drug abuse

          -  Routinely consumes >2 alcoholic drinks per day or >14 alcoholic drinks per week, or
             engages in binge drinking

          -  Has donated blood products or has had a phlebotomy within 8 weeks of study
             participation, or intends to donate blood products during the study or has received,
             or is anticipated to receive, blood products within 12 weeks of study participation or
             during the study