A Study to Evaluate the Safety and Efficacy of MK-3102 Compared With Glimepiride in Participants With Type 2 Diabetes Mellitus for Whom Metformin is Inappropriate (MK-3102-027)

This study has been terminated.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
First received: May 23, 2013
Last updated: April 29, 2014
Last verified: April 2014
This trial will assess the safety and efficacy of MK-3102 compared with the sulfonylurea, glimepiride, in Type 2 diabetes mellitus participants who are metformin intolerant or who have a contraindication to the use of metformin.

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase III, Multicenter, Double-Blind, Randomized Trial to Evaluate the Safety and Efficacy of MK-3102 Compared With Glimepiride in Subjects With Type 2 Diabetes Mellitus For Whom Metformin is Inappropriate Due to Intolerance or Contraindication

Resource links provided by NLM:

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

Primary Outcome Measures:
  • Change from Baseline in A1C at Week 54 [ Time Frame: Baseline and Week 54 ] [ Designated as safety issue: No ]
  • Percentage of Participants Who Experienced at Least One Adverse Event [ Time Frame: 57 weeks ] [ Designated as safety issue: Yes ]
  • Percentage of Participants Who Discontinued from the Study Due to an Adverse Event [ Time Frame: 54 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change from Baseline in Fasting Plasma Glucose (FPG) at Week 54 [ Time Frame: Baseline and Week 54 ] [ Designated as safety issue: No ]
  • Percentage of Participants Achieving an A1C Goal <7.0% and <6.5% After 54 weeks of Treatment [ Time Frame: 54 weeks ] [ Designated as safety issue: No ]
  • Percentage of Participants Meeting the Composite Endpoint of an A1C Decrease >0.5%, No Symptomatic Hypoglycemia, and No Body Weight Gain after 54 Weeks of Treatment [ Time Frame: 54 weeks ] [ Designated as safety issue: No ]
  • Percentage of Participants with an Adverse Event of Symptomatic Hypoglycemia [ Time Frame: 54 weeks ] [ Designated as safety issue: Yes ]
  • Change from Baseline in Body Weight at Week 54 [ Time Frame: Baseline and Week 54 ] [ Designated as safety issue: Yes ]

Enrollment: 65
Study Start Date: July 2013
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MK-3102
Participants receive an MK-3102 25 mg capsule once weekly and glimepiride placebo tablet(s) once daily, for 54 weeks.
Drug: MK-3102 Drug: Glimepiride Placebo
Active Comparator: Glimepiride
Participants receive glimepiride tablet(s) (1 mg or 2 mg, maximum dose 6 mg/day) once daily and an MK-3102 placebo capsule once weekly, for 54 weeks.
Drug: Glimepiride
Other Names:
Drug: MK-3102 Placebo


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Diagnosed with Type 2 diabetes mellitus
  • Have intolerability to metformin ≥1000 mg/day or have a contraindication to the use of metformin
  • Females of reproductive potential agree to remain abstinent or use or have their partner use 2 acceptable methods of birth control

Exclusion Criteria:

  • History of type 1 diabetes mellitus or a history of ketoacidosis or assessed by the investigator as possibly having type 1 diabetes
  • Has been treated with:

    1. A thiazolidinedione (TZD) within 4 months of study participation, or
    2. A glucagon-like peptide-1 (GLP-1) receptor mimetic or agonist (such as exenatide or liraglutide) within 6 months of study participation, or
    3. Insulin within 12 weeks prior to study participation, or
    4. Dual antihyperglycemic agent (AHA) therapy within 12 weeks of study participation (4 months if a component of the dual AHA therapy was a TZD)
    5. MK-3102 at any time prior to study participation
  • On a weight loss program and is not in the maintenance phase; has started 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
  • 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
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No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01863667     History of Changes
Other Study ID Numbers: 3102-027, 2013-000301-23
Study First Received: May 23, 2013
Last Updated: April 29, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Anti-Arrhythmia Agents
Cardiovascular Agents
Hypoglycemic Agents
Immunologic Factors
Immunosuppressive Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2015