A Study of the Safety and Efficacy of MK-3102 Compared With Glimepiride in Participants With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin (MK-3102-016 AM2)
Overview[ - collapse ][ - ]
Purpose | This trial will assess the safety and efficacy of MK-3102 compared with the sulfonylurea, glimepiride, in Type 2 diabetes mellitus participants with inadequate glycemic control on metformin monotherapy. |
---|---|
Condition | Type 2 Diabetes Mellitus |
Intervention | Drug: MK-3102 Drug: MK-3102 Placebo Drug: Glimepiride Drug: Glimepiride Placebo Drug: Metformin Drug: Insulin Glargine |
Phase | Phase 3 |
Sponsor | Merck Sharp & Dohme Corp. |
Responsible Party | Merck Sharp & Dohme Corp. |
ClinicalTrials.gov Identifier | NCT01682759 |
First Received | September 7, 2012 |
Last Updated | March 13, 2014 |
Last verified | March 2014 |
Tracking Information[ + expand ][ + ]
First Received Date | September 7, 2012 |
---|---|
Last Updated Date | March 13, 2014 |
Start Date | September 2012 |
Estimated Primary Completion Date | January 2015 |
Current Primary Outcome Measures |
|
Current Secondary Outcome Measures |
|
Descriptive Information[ + expand ][ + ]
Brief Title | A Study of the Safety and Efficacy of MK-3102 Compared With Glimepiride in Participants With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin (MK-3102-016 AM2) |
---|---|
Official Title | A Phase III, Multicenter, Double-Blind, Randomized Study to Evaluate the Safety and Efficacy of the Addition of MK-3102 Compared With the Addition of Glimepiride in Subjects With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin |
Brief Summary | This trial will assess the safety and efficacy of MK-3102 compared with the sulfonylurea, glimepiride, in Type 2 diabetes mellitus participants with inadequate glycemic control on metformin monotherapy. |
Detailed Description | Not Provided |
Study Type | Interventional |
Study Phase | Phase 3 |
Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment |
Condition | Type 2 Diabetes Mellitus |
Intervention | Drug: MK-3102 MK-3102 (25 mg) will be administered in a blinded manner as one capsule once a week (q.w.) Drug: MK-3102 Placebo Placebo matching MK-3102 (25 mg) Drug: Glimepiride Glimepiride (1 mg and/or 2 mg tablets). During the double-blind treatment period, glimepiride can be up-titrated, as appropriate, to a maximum total daily dose of 6 mg/day. Throughout the trial, down-titration of glimepiride may also occur based upon the participant's glucose measurements and clinical symptoms of hypoglycemia. Other Names:
Placebos matching glimepiride 1 mg and/or 2 mg Drug: Metformin Open-label Drug: Insulin Glargine Insulin glargine can be used for rescue therapy, if glycemic control is not maintained. |
Study Arm (s) |
|
Recruitment Information[ + expand ][ + ]
Recruitment Status | Active, not recruiting |
---|---|
Estimated Enrollment | 680 |
Estimated Completion Date | January 2015 |
Estimated Primary Completion Date | January 2015 |
Eligibility Criteria | 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 MK-3102 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 |
Gender | Both |
Ages | 18 Years |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | Not Provided |
Administrative Information[ + expand ][ + ]
NCT Number | NCT01682759 |
---|---|
Other Study ID Numbers | 3102-016 |
Has Data Monitoring Committee | Yes |
Information Provided By | Merck Sharp & Dohme Corp. |
Study Sponsor | Merck Sharp & Dohme Corp. |
Collaborators | Not Provided |
Investigators | Not Provided |
Verification Date | March 2014 |