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.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01703208
First received: October 5, 2012
Last updated: March 20, 2014
Last verified: March 2014

October 5, 2012
March 20, 2014
October 2012
October 2017   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01703208 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Study to Assess Cardiovascular Outcomes Following Treatment With MK-3102 in Participants With Type 2 Diabetes Mellitus (MK-3102-018 AM5)
A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Assess Cardiovascular Outcomes Following Treatment With MK-3102 in Subjects With Type 2 Diabetes Mellitus

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
4000
October 2017
October 2017   (final data collection date for primary outcome measure)

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
Both
40 Years and older
No
Contact: Toll Free Number 1-888-577-8839
United States,   Australia,   Austria,   Belgium,   Bulgaria,   Canada,   Chile,   Colombia,   Croatia,   Czech Republic,   Denmark,   Finland,   France,   Georgia,   Germany,   Hong Kong,   Hungary,   Israel,   Italy,   Korea, Republic of,   Lebanon,   Lithuania,   Malaysia,   Netherlands,   New Zealand,   Philippines,   Poland,   Romania,   Russian Federation,   Serbia,   Slovakia,   South Africa,   Spain,   Sweden,   Ukraine,   United Kingdom
 
NCT01703208
3102-018, 2012-002414-39
Yes
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP