A Study of the Safety and Efficacy of Omarigliptin (MK-3102) Compared With Glimepiride in Participants With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin (MK-3102-016)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Metformin; Drug: Insulin Glargine; Drug: Glimepiride; Drug: Glimepiride Placebo; Drug: Placebo to Omarigliptin; Drug: Omarigliptin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01682759

MK-3102-016 (Other Identifier)

3102-016

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 with inadequate glycemic control on metformin monotherapy. The primay hypothesis of the study 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: 751 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosed with Type 2 diabetes mellitus
• On a stable dose of metformin (≥1500 mg/day) for at least 12 weeks with inadequate glycemic control
• Females of reproductive potential agree to remain abstinent or use or have their partner use acceptable methods of birth control

Exclusion criteria

• History of type 1 diabetes mellitus or a history of ketoacidosis
• Treated with any antihyperglycemic agents (AHA) therapies other than the protocol-required metformin within the prior 12 weeks of study participation or with omarigliptin at any time prior to signing informed consent
• On a weight loss program and is not in the maintenance phase or 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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751 participants in 2 patient groups

Omarigliptin

Experimental group

Description:

Participants will receive omarigliptin, 25 mg once weekly and placebo matching glimepiride once daily for up to 54 weeks.

Treatment:

Drug: Insulin Glargine

Drug: Metformin

Drug: Glimepiride Placebo

Drug: Omarigliptin

Glimepiride

Active Comparator group

Description:

Participants will receive glimepiride titrated to a maximum of 6 mg, once daily, and placebo to omarigliptin, once weekly for up to 54 weeks.

Treatment:

Drug: Glimepiride

Drug: Insulin Glargine

Drug: Metformin

Drug: Placebo to Omarigliptin