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)

NCT ID: NCT01863667

Last Updated: 2018-09-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-08
• Study Completion Date: 2014-04-03

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.

Conditions

Type 2 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Omarigliptin

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

Group Type: EXPERIMENTAL

Omarigliptin

Intervention Type: DRUG

Omarigliptin (MK-3102) 25 mg capsule administered orally once weekly

Glimepiride Placebo

Intervention Type: DRUG

Matching placebo to glimepiride tablet administered orally once daily with breakfast or the first main meal

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.

Group Type: ACTIVE_COMPARATOR

Glimepiride

Intervention Type: DRUG

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

Omarigliptin Placebo

Intervention Type: DRUG

Matching placebo to omarigliptin capsule administered orally once weekly

Interventions

Omarigliptin

Omarigliptin (MK-3102) 25 mg capsule administered orally once weekly

Intervention Type: 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

Intervention Type: DRUG

Omarigliptin Placebo

Matching placebo to omarigliptin capsule administered orally once weekly

Intervention Type: DRUG

Glimepiride Placebo

Matching placebo to glimepiride tablet administered orally once daily with breakfast or the first main meal

Intervention Type: DRUG

Other Intervention Names

AMARYL®; GLIMY

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Study Documents

Document Type: CSR Synopsis Link

View Document

Other Identifiers

2013-000301-23

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

3102-027

Identifier Type: -

Identifier Source: org_study_id