A Dose-Range Finding Study in Participants With Type 2 Diabetes (MK-3102-006)
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Omarigliptin; Placebo to omarigliptin; Pioglitazone; Metformin; Placebo to metformin
Intervention description: Omarigliptin 0.25, 1, 1.5, 10 or 25 mg oral capsule administered once weekly. For omarigliptin 3 mg, participants received two omarigliptin 1.5 mg capsules.; Matching placebo to omarigliptin 0.25, 1, 1.5, 10 or 25 mg oral capsule administered once weekly. For matching placebo to omarigliptin 3 mg, participants received two matching placebo to omarigliptin 1.5 mg capsules.; Pioglitazone 15 mg oral tablet or capsule administered once daily; Metformin 500 mg oral tablet administered once or twice daily; Matching placebo to metformin oral tablet administered once daily
Intervention MeSH terms: Metformin; Pioglitazone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 685.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the hypothesis that treatment with study medication
      (omarigliptin; MK-3102) provides greater reduction in A1C Hemoglobin (a marker of diabetic
      severity) compared with placebo, after 12 weeks of treatment. The study will evaluate 5
      different doses of omarigliptin to identify which dose is the most effective in the treatment
      of type 2 diabetes.
    

Eligibility criteria:

        Inclusion Criteria:

        The prospective participant must meet, at least, all of the criteria below (among others
        determined by the study staff) to be eligible for study participation.

        The participant:

          -  Has type 2 diabetes mellitus and is between 18 and 70 years of age; for Japan, 20 to
             70 years of age;

          -  Has a body mass index (BMI) > 20 kg/m^2 and < 43 kg/m^2; for Japan: BMI >18 kg/m^2 and
             <43 kg/m^2;

          -  Is currently not on an antihyperglycemic agent (AHA) medication (off for ≥ 14 weeks)
             or is on oral AHA therapy but has inadequate glycemic control;

          -  Is a male, or a female who is highly unlikely to conceive.

        Exclusion Criteria:

        If the prospective participant meets any of the criteria below (among others determined by
        the study staff) they will NOT be eligible for study participation.

        The participant:

          -  Has a history of type 1 diabetes mellitus or a history of ketoacidosis;

          -  Is on a weight loss program or has started a weight loss medication within the prior 8
             weeks;

          -  Has required insulin therapy within 14 weeks prior to signing informed consent;

          -  Has a medical history of active liver disease (other than nonalcoholic hepatic
             steatosis), including chronic active hepatitis B or C, cirrhosis, or symptomatic
             gallbladder disease;

          -  Has congestive heart failure or has new or worsening signs or symptoms of coronary
             heart disease;

          -  Had any of the following disorders within the past 3 months: acute coronary syndrome,
             coronary artery intervention, stroke or transient ischemic neurological disorder;

          -  Has a history of malignancy or clinically important hematological disorder