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

This study is currently recruiting participants.
Verified April 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: April 14, 2014
Last verified: April 2014
  Purpose

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 the cardiovascular (CV) composite endpoint of CV-related death, nonfatal myocardial infarction (MI), nonfatal stroke, or unstable angina requiring hospitalization [ Time Frame: Up to 156 weeks ] [ Designated as safety issue: Yes ]
  • Change from baseline in hemoglobin A1C (A1C) at Week 18 in a sub-study of participants taking insulin (with or without metformin) [ Time Frame: Baseline and Week 18 ] [ Designated as safety issue: No ]
  • Percentage of participants who experienced at least one adverse event in a sub-study of participants taking insulin (with or without metformin) [ Time Frame: Up to Week 18 ] [ Designated as safety issue: Yes ]
  • Percentage of participants who discontinued from study drug due to an adverse event in a sub-study of participants taking insulin (with or without metformin) [ Time Frame: Up to Week 18 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Time to first composite CV endpoint of confirmed CV-related death, nonfatal MI, and nonfatal stroke [ Time Frame: Up to 156 weeks ] [ Designated as safety issue: Yes ]
  • Time to first event for each of the individual CV endpoints: confirmed CV-related death, MI (fatal + nonfatal), stroke (fatal + nonfatal), and unstable angina requiring hospitalization [ Time Frame: Up to 156 weeks ] [ Designated as safety issue: Yes ]
  • Time to all-cause mortality [ Time Frame: Up to 156 weeks ] [ Designated as safety issue: Yes ]
  • Change from baseline in A1C at Week 156 [ Time Frame: Baseline and Week 156 ] [ Designated as safety issue: No ]
  • Change from baseline in fasting plasma glucose (FPG) at Week 156 [ Time Frame: Baseline and Week 156 ] [ Designated as safety issue: No ]
  • Percentage of participants achieving a target A1C <7.0 % (53 mmol/mol) by Week 156 [ Time Frame: Up to 156 weeks ] [ Designated as safety issue: No ]
  • Time to initiation of long-term insulin therapy (long-term insulin therapy is defined as a continuous period of insulin use of more than 3 months) in participants not receiving insulin at baseline [ Time Frame: Up to 156 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in FPG at Week 18 in a sub-study of participants taking insulin (with or without metformin) [ Time Frame: Baseline and Week 18 ] [ Designated as safety issue: No ]
  • Percentage of participants achieving a target A1C <7.0 % (53 mmol/mol) by Week 18 in a sub-study of participants taking insulin (with or without metformin) [ Time Frame: Up to 18 weeks ] [ Designated as safety issue: No ]
  • 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 study drug due to an adverse event [ Time Frame: Up to 156 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 4000
Study Start Date: October 2012
Estimated Study Completion Date: November 2017
Estimated Primary Completion Date: November 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 weekly
Drug: Placebo

  Eligibility

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

Inclusion Criteria:

  • Diagnosed with type 2 diabetes mellitus
  • Is on one of the following diabetes treatment regimens that is stable for at least 12 weeks (except for pioglitazone for at least 16 weeks) and is within the associated A1C range for that treatment regimen:

    1. A1C >= 6.5% and <= 10.0% (>=48 mmol/mol and <=86 mmol/mol) on: (a) diet or exercise alone (not on antihyperglycemic agent [AHA] for >= 12 weeks) OR (b) monotherapy with metformin (MF), pioglitazone (PIO) or an alpha-glucosidase inhibitor (AGI) or a sodium-glucose cotransporter inhibitor (SGLT2i) OR (c) dual combination therapy with MF, PIO, AGI or SGLT2i OR
    2. A1C >= 7.0% and <=10.0% (>=53 mmol/mol and <=86 mmol/mol) on (a) monotherapy with a sulfonylurea or meglitinide OR (b) dual combination therapy with a sulfonylurea or a meglitinide and MF, PIO, AGI, or SGLT2i OR
    3. A1C >=7.0% and <=10.0% (>=53 mmol/mol and <=86 mmol/mol) on one of the following insulin regimens (with or without metformin): (a) basal insulin (e.g.; insulin glargine, insulin detemir, NPH insulin, degludec) OR (b) prandial insulin (e.g. regular, aspart, lispro, glulisine) OR (c) basal/prandial insulin regimen consisting of multiple dose insulin injections of basal and prandial insulin or the use of pre-mixed insulin (e.g., Novolog 70/30®, Novolin 70/30®, Humalog 75/25®, or Humulin 70/30®
  • 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 or previously treated with MK-3102
  • On a weight loss program and is not in the maintenance phase or has been on a weight loss medication in the past 6 months 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) as assessed by medical history
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01703208

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

  Show 135 Study Locations
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Director Merck Sharp & Dohme Corp.
  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: April 14, 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 23, 2014