Clinical trial NCT01863667: 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)
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2013-05-29
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Change From Baseline in Hemoglobin A1C (A1C) at Week 54
timeFrame: Baseline and Week 54
measure: Percentage of Participants Who Experienced at Least One Adverse Event
timeFrame: Up to 57 weeks (including 3 weeks following the last dose of study drug)
measure: Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event
timeFrame: Up to 54 weeks
Secondary outcomes:
measure: Change From Baseline in Fasting Plasma Glucose (FPG) at Week 54
timeFrame: Baseline and Week 54
measure: Percentage of Participants Achieving an A1C Goal <7.0% or <6.5% After 54 Weeks of Treatment
timeFrame: 54 weeks
measure: 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
timeFrame: 54 weeks
measure: Percentage of Participants With an Adverse Event of Symptomatic Hypoglycemia
timeFrame: Up to 54 weeks
measure: Change From Baseline in Body Weight at Week 54
timeFrame: Baseline and Week 54
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: