A Study to Evaluate the Safety and Efficacy of Omarigliptin (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: December 15, 2015
Last verified: December 2015
  Purpose
This trial will assess the safety and efficacy of omarigliptin (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. The primary hypothesis is that after 54 weeks, the mean change from baseline in hemoglobin A1c (A1C) in participants treated with omarigliptin is non-inferior compared with that in participants treated with glimepiride.

Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: Omarigliptin
Drug: Glimepiride
Drug: Omarigliptin 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 Hemoglobin A1C (A1C) at Week 54 [ Time Frame: Baseline and Week 54 ] [ Designated as safety issue: No ]
    A1C is measured as a percent. Thus, this change from baseline reflects the Week 54 A1C percent minus the Week 0 A1C percent.

  • Percentage of Participants Who Experienced at Least One Adverse Event [ Time Frame: Up to 57 weeks (including 3 weeks following the last dose of study drug) ] [ Designated as safety issue: Yes ]
    An adverse event is any untoward medical occurrence in a participant administered study drug which does not necessarily have a causal relationship with the treatment. Adverse events may include the onset of new illness and the exacerbation of pre-existing conditions.

  • Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event [ Time Frame: Up to 54 weeks ] [ Designated as safety issue: Yes ]
    An adverse event is any untoward medical occurrence in a participant administered study drug which does not necessarily have a causal relationship with the treatment. Adverse events may include the onset of new illness and the exacerbation of pre-existing conditions.


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 ]
    This change from baseline reflects the FPG level at Week 54 minus the FPG level at Week 0.

  • Percentage of Participants Achieving an A1C Goal <7.0% or <6.5% After 54 Weeks of Treatment [ Time Frame: 54 weeks ] [ Designated as safety issue: No ]
    Percentage of participants achieving glycemic goal (A1C <7% or <6.5%) after 54 weeks of treatment.

  • 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 who had an A1C decrease >0.5%, no symptomatic hypoglycemia, and no body weight gain after 54 weeks of treatment

  • Percentage of Participants With an Adverse Event of Symptomatic Hypoglycemia [ Time Frame: Up to 54 weeks ] [ Designated as safety issue: Yes ]
    An adverse event (AE) is any untoward medical occurrence in a participant administered study drug which does not necessarily have a causal relationship with the treatment. AEs may include the onset of new illness and the exacerbation of pre-existing conditions. Per protocol, an adverse event was defined as symptomatic hypoglycemia if hypoglycemia was an adverse event collected on the AE form AND the symptoms associated with it were collected on the hypoglycemia assessment (HA) form. Due to the early termination of the study, the HA form information was not assessed; therefore, this endpoint cannot be reported.

  • Change From Baseline in Body Weight at Week 54 [ Time Frame: Baseline and Week 54 ] [ Designated as safety issue: Yes ]
    Body weight was to be measured (in duplicate) using a calibrated digital scale.


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: Omarigliptin
Participants receive an omarigliptin (MK-3102) 25 mg capsule once weekly and glimepiride placebo tablet(s) once daily, for 54 weeks.
Drug: Omarigliptin
Omarigliptin (MK-3102) 25 mg capsule administered orally once weekly
Drug: Glimepiride Placebo
Matching placebo to glimepiride tablet administered orally once daily with breakfast or the first main meal
Active Comparator: Glimepiride
Participants receive glimepiride 1 mg and/or 2 mg tablet(s) (maximum dose 6 mg/day) once daily and an omarigliptin placebo capsule once weekly, for 54 weeks.
Drug: Glimepiride
Glimepiride tablet 1 mg and/or 2 mg (uptitrated to a maximum dose 6 mg/day) administered orally once daily with breakfast or the first main meal
Other Names:
  • AMARYL®
  • GLIMY
Drug: Omarigliptin Placebo
Matching placebo to omarigliptin capsule administered orally once weekly

  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. Omarigliptin (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 (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
  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.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01863667

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Director Merck Sharp & Dohme Corp.
  More Information

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
Results First Received: September 29, 2015
Last Updated: December 15, 2015
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
Glimepiride
Anti-Arrhythmia Agents
Hypoglycemic Agents
Immunologic Factors
Immunosuppressive Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 26, 2016