A Study of the Safety and Efficacy of MK-3102 in ≥18 and <45 Year-Old Subjects With Type 2 Diabetes Mellitus and Inadequate Glycemic Control (MK-3102-028)

• Change from Baseline in A1C at Week 24 [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
• Percentage of Participants Who Experienced at Least One Adverse Event [ Time Frame: Up to Week 27 ] [ Designated as safety issue: Yes ]
• Percentage of Participants Who Discontinued from the Study Due to an Adverse Event [ Time Frame: Up to Week 24 ] [ Designated as safety issue: Yes ]

• Change from Baseline in 2-hour Post-Meal Glucose (PMG) at Week 24 [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
• Change in Baseline in Fasting Plasma Glucose (FPG) at Week 24 [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
• Number of Participants Attaining A1C Glycemic Goals of <7.0% and <6.5% at Week 24 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
• Time to Participant Rescue with Open-label Metformin for Participants Exceeding Pre-specified Glycemic Thresholds [ Time Frame: Up to Week 24 ] [ Designated as safety issue: No ]

This study will examine the safety and efficacy of once-weekly MK-3102 in

participants 18 to <45 years of age with Type 2 diabetes mellitus and inadequate glycemic control. The study hypothesis is that treatment with MK-3102 compared with placebo provides greater reduction in hemoglobin A1c (A1C) in participants after 24 weeks.

• Drug: MK-3102
  MK-3102 25 mg capsule administered orally once weekly
• Drug: Placebo to MK-3102
  Matching placebo to MK-3102 25 mg capsule administered orally once weekly
• Drug: Metformin
  Participants exceeding pre-specified glycemic thresholds during the double-blind treatment period will receive rescue therapy with open-label metformin.
  Other Names:

  • Fortamet®
  • Glucophage®
  • Glucophage® XR
  • Glumetza®
  • Riomet®
  • Metgluco®
  • Glycoran®

• Experimental: MK-3102 25 mg
  MK-3102 25 mg, once weekly, for 24 weeks
  Interventions:

  • Drug: MK-3102
  • Drug: Metformin
• Placebo Comparator: Placebo
  Placebo to MK-3102, once weekly, for 24 weeks
  Interventions:

  • Drug: Placebo to MK-3102
  • Drug: Metformin

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 MK-3102 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