A Study to Assess Cardiovascular Outcomes Following Treatment With MK-3102 in Participants With Type 2 Diabetes Mellitus (MK-3102-018 AM5)

• Time to first event in primary cardiovascular (CV) composite endpoint (CV-related death, nonfatal myocardial infarction, nonfatal stroke, or unstable angina requiring hospitalization) [ Time Frame: up to 156 weeks ] [ Designated as safety issue: Yes ]
• Percentage of Participants Who Experienced at Least One Adverse Event [ Time Frame: up to 159 weeks ] [ Designated as safety issue: Yes ]
• Percentage of Participants Who Discontinued from the Study Due to an Adverse Event [ Time Frame: up to 156 weeks ] [ Designated as safety issue: Yes ]

• Time to first major adverse cardiac event (CV-related death, nonfatal myocardial infarction, and nonfatal stroke) [ Time Frame: up to 156 weeks ] [ Designated as safety issue: Yes ]
• Time to CV-related death [ Time Frame: up to 156 weeks ] [ Designated as safety issue: Yes ]
• Time to nonfatal myocardial infarction [ Time Frame: up to 156 weeks ] [ Designated as safety issue: Yes ]
• Time to nonfatal stroke [ Time Frame: up to 156 weeks ] [ Designated as safety issue: Yes ]
• Time to unstable angina requiring hospitalization [ Time Frame: up to 156 weeks ] [ Designated as safety issue: Yes ]

The purpose of this study is to evaluate the cardiovascular (CV) safety profile of MK-3102 in participants with type 2 diabetes mellitus (T2DM). The primary hypothesis is that treatment with MK-3102 25 mg once weekly is non-inferior to treatment with placebo and active comparators across the MK-3102 program with regard to the risk of developing a confirmed event in the primary CV composite endpoint.

• Drug: MK-3102
• Drug: Placebo

• Experimental: MK-3102
  MK-3102 25 mg capsule administered orally once weekly
  Intervention: Drug: MK-3102
• Placebo Comparator: Placebo
  Matching placebo to MK-3102 capsule administered orally once a week
  Intervention: Drug: Placebo

Inclusion Criteria:

• Diagnosed with type 2 diabetes mellitus

• Receiving one of the following diabetes treatment regimens:

  1. treated by diet or exercise alone (not on antihyperglycemic agent for at least 12 weeks)
  2. on metformin, a sulfonylurea, a meglitinide, pioglitazone, an alpha-glucosidase or a sodium-glucose cotransporter inhibitor as mono- or dual combination therapy continuously for at least 12 weeks (at least 16 weeks for pioglitazone)
  3. on a stable insulin regimen with or without metformin
• Pre-existing vascular disease (coronary artery disease, ischemic cerebrovascular disease, atherosclerotic peripheral artery disease)
• (1) Male; (2) female not of reproductive potential; or (3) female of reproductive potential who agrees to remain abstinent or use alone or in conjunction with their partner 2 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
• Treated with rosiglitazone, a dipeptidyl peptidase-IV (DPP-4) inhibitor, or a glucagon-like peptide-1 (GLP-1) receptor agonist within 12 weeks prior to study participation
• On a weight loss program and is not in the maintenance phase or has started a weight loss medication or has undergone bariatric surgery within 12 months prior to study participation
• 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
• 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