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)

Merck Sharp & Dohme (MSD)

Status and phase: Terminated; Phase 3

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Glimepiride Placebo; Drug: Omarigliptin; Drug: Omarigliptin Placebo; Drug: Glimepiride

Study type: Interventional

Funder types: Industry

Identifiers

NCT01863667

2013-000301-23 (EudraCT Number)

3102-027

Details and patient eligibility

About

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.

Enrollment: 65 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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65 participants in 2 patient groups

Omarigliptin

Experimental group

Description:

Participants receive an omarigliptin (MK-3102) 25 mg capsule once weekly and glimepiride placebo tablet(s) once daily, for 54 weeks.

Treatment:

Drug: Glimepiride Placebo

Drug: Omarigliptin

Glimepiride

Active Comparator group

Description:

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.

Treatment:

Drug: Glimepiride

Drug: Omarigliptin Placebo