A Study of the Safety and Efficacy of Omarigliptin (MK-3102) in ≥18 and <45 Year-Old Participants With Type 2 Diabetes Mellitus and Inadequate Glycemic Control (MK-3102-028)
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Omarigliptin; Placebo to omarigliptin; Metformin
Intervention description: Omarigliptin 25 mg capsule administered orally once weekly; Matching placebo to omarigliptin 25 mg capsule administered orally once weekly; Open-label metformin (dosed daily according to the country-specific product label) was to be initiated for participants meeting protocol-specified glycemic criteria, but was otherwise prohibited.
Intervention MeSH terms: Metformin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 203.0
Sex: All
Minimum age: 18 Years
Maximum age: 44 Years
Healthy volunteers: No
Keywords: Diabetes Mellitus; Diabetes Mellitus, Type 2; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Metformin; Hypoglycemic Agents; Pharmacologic Actions; Therapeutic Uses

Summary:

      This study will examine the safety and efficacy of once-weekly omarigliptin in participants
      18 to <45 years of age with Type 2 diabetes mellitus and inadequate glycemic control. The
      study hypothesis is that treatment with omarigliptin compared with placebo provides greater
      reduction in hemoglobin A1c (A1C) in participants after 24 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has type 2 diabetes mellitus

          -  Currently not on an antihyperglycemic agent (AHA) for at least the past 12 weeks and
             has not been treated with omarigliptin at any time prior to study participation

          -  Participant is one of the following:

               1. Male

               2. Female who is not of reproductive potential

               3. Female of reproductive potential who agrees to remain abstinent from heterosexual
                  activity or use (or have her partner use) 2 acceptable methods of 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

          -  History of hypersensitivity to dipeptidyl-peptidase-4 (DPP-4) inhibitor

          -  Currently participating in or has participated in a clinical trial in the past 12
             weeks

          -  Is on a weight loss program and not in the maintenance phase; has been on 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
             pharmacologic doses of corticosteroids

          -  Is currently being treated for hyperthyroidism or is on thyroid replacement 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 hepatic steatosis) including
             chronic active hepatitis B or C, primary biliary cirrhosis, or symptomatic gallbladder
             disease

          -  Has 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:

               1. Acute coronary syndrome

               2. Coronary artery intervention

               3. 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

          -  Has a hematological disorder (such as aplastic anemia, myeloproliferative or
             myelodysplastic syndromes, thrombocytopenia)

          -  Has a positive urine pregnancy test

          -  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 (>300 mL) 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

          -  Has a clinically significant electrocardiogram abnormality