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)
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- Registration Number
- NCT01682759
- Lead Sponsor
- Merck Sharp & Dohme LLC
- 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 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 751
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Glimepiride Placebo to Omarigliptin Participants will receive glimepiride titrated to a maximum of 6 mg, once daily, and placebo to omarigliptin, once weekly for up to 54 weeks. Glimepiride Glimepiride Participants will receive glimepiride titrated to a maximum of 6 mg, once daily, and placebo to omarigliptin, once weekly for up to 54 weeks. Glimepiride Metformin Participants will receive glimepiride titrated to a maximum of 6 mg, once daily, and placebo to omarigliptin, once weekly for up to 54 weeks. Omarigliptin Omarigliptin Participants will receive omarigliptin, 25 mg once weekly and placebo matching glimepiride once daily for up to 54 weeks. Omarigliptin Glimepiride Placebo Participants will receive omarigliptin, 25 mg once weekly and placebo matching glimepiride once daily for up to 54 weeks. Omarigliptin Metformin Participants will receive omarigliptin, 25 mg once weekly and placebo matching glimepiride once daily for up to 54 weeks. Omarigliptin Insulin Glargine Participants will receive omarigliptin, 25 mg once weekly and placebo matching glimepiride once daily for up to 54 weeks. Glimepiride Insulin Glargine Participants will receive glimepiride titrated to a maximum of 6 mg, once daily, and placebo to omarigliptin, once weekly for up to 54 weeks.
- Primary Outcome Measures
Name Time Method Change From Baseline in Hemoglobin A1C at Week 54 Baseline and Week 54 Hemoglobin A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). Thus, this change from baseline reflects the Week 54 A1C minus the Week 0 A1C.
Percentage of Participants Who Experienced at Least One Adverse Event Excluding Data After Glycemic Rescue Up to Week 57 An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
Percentage of Participants Who Discontinued From the Study Due to an Adverse Event Excluding Data After Glycemic Rescue Up to Week 54
- Secondary Outcome Measures
Name Time Method Percentage of Participants With an Adverse Event of Symptomatic Hypoglycemia Excluding Data After Glycemic Rescue Up to Week 54 Symptomatic episode of hypoglycemia was an episode with clinical symptoms reported by the investigator as hypoglycemia (concurrent fingerstick glucose not required).
Percentage of Participants Achieving a Hemoglobin A1C of <6.5% at Week 54 Week 54 The percentage of participants who achieved A1C values \<6.5% (48 mmol/mol) in the FAS Population at Week 54.
Change From Baseline in Fasting Plasma Glucose at Week 54 Baseline and Week 54 Blood glucose was measured on a fasting basis. FPG is expressed as mg/dL. Blood was drawn at predose on Day 1 and after 54 weeks of treatment to determine change in plasma glucose levels (i.e., FPG at Week 54 minus FPG at baseline).
Change From Baseline in Body Weight at Week 54 Excluding Data After Gylcemic Rescue Baseline and Week 54 Percentage of Participants Achieving a Hemoglobin A1C of <7.0% at Week 54 Week 54 The percentage of participants who achieved A1C values \<7.0% (53 mmol/mol) in the FAS Population at Week 54.