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.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01863667
First received: May 23, 2013
Last updated: April 29, 2014
Last verified: April 2014
  Purpose

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:
  • AMARYL®
  • GLIMY
Drug: MK-3102 Placebo

  Eligibility

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glimepiride
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on July 31, 2014