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

This study is currently recruiting participants.
Verified March 2014 by Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
First received: October 5, 2012
Last updated: March 20, 2014
Last verified: March 2014

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.

Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: MK-3102
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Assess Cardiovascular Outcomes Following Treatment With MK-3102 in Subjects With Type 2 Diabetes Mellitus

Resource links provided by NLM:

Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 4000
Study Start Date: October 2012
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MK-3102
MK-3102 25 mg capsule administered orally once weekly
Drug: MK-3102
Placebo Comparator: Placebo
Matching placebo to MK-3102 capsule administered orally once a week
Drug: Placebo


Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01703208

Contact: Toll Free Number 1-888-577-8839

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  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01703208     History of Changes
Other Study ID Numbers: 3102-018, 2012-002414-39
Study First Received: October 5, 2012
Last Updated: March 20, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 14, 2014