Addition of MK-3102 to Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Combination Therapy With Glimepiride and Metformin (MK-3102-022 AM4)
Overview[ - collapse ][ - ]
| Purpose | This study will examine the safety and efficacy of the addition of MK-3102 in participants with type 2 diabetes mellitus with inadequate glycemic control on metformin and sulfonylurea. The primary hypothesis is that after 24 weeks, the addition of treatment with MK-3102 provides a greater reduction in hemoglobin A1c (A1C) compared with the addition of placebo. |
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| Condition | Type 2 Diabetes Mellitus |
| Intervention | Drug: MK-3102 Drug: Matching placebo to MK-3012 Drug: Glimepiride Drug: Metformin |
| Phase | Phase 3 |
| Sponsor | Merck Sharp & Dohme Corp. |
| Responsible Party | Merck Sharp & Dohme Corp. |
| ClinicalTrials.gov Identifier | NCT01704261 |
| First Received | October 8, 2012 |
| Last Updated | April 10, 2014 |
| Last verified | April 2014 |
Tracking Information[ + expand ][ + ]
| First Received Date | October 8, 2012 |
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| Last Updated Date | April 10, 2014 |
| Start Date | October 2012 |
| Estimated Primary Completion Date | December 2014 |
| Current Primary Outcome Measures |
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| Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
| Brief Title | Addition of MK-3102 to Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Combination Therapy With Glimepiride and Metformin (MK-3102-022 AM4) |
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| Official Title | A Phase III, Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial to Study the Safety and Efficacy of the Addition of MK-3102 to Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Combination Therapy With Glimepiride and Metformin |
| Brief Summary | This study will examine the safety and efficacy of the addition of MK-3102 in participants with type 2 diabetes mellitus with inadequate glycemic control on metformin and sulfonylurea. The primary hypothesis is that after 24 weeks, the addition of treatment with MK-3102 provides a greater reduction in hemoglobin A1c (A1C) compared with the addition of placebo. |
| 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, Outcomes Assessor), Primary Purpose: Treatment |
| Condition | Type 2 Diabetes Mellitus |
| Intervention | Drug: MK-3102 MK-3102 25 mg capsule administered orally once a week Drug: Matching placebo to MK-3012 Matching placebo to MK-3102 capsule administered orally once a week Drug: Glimepiride Open-label glimepiride tablet(s) administered orally once daily for a total daily dose >=4 mg. In the event of hypoglycemia, the glimepiride dose may be down-titrated to a minimum dose of 1 mg daily. Other Names:
Open-label metformin tablet(s) administered orally once or twice daily for a total daily dose >=1500 mg Other Names:
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| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Recruiting |
|---|---|
| Estimated Enrollment | 300 |
| Estimated Completion Date | December 2014 |
| Estimated Primary Completion Date | December 2014 |
| Eligibility Criteria | Inclusion Criteria: - Diagnosed with type 2 diabetes mellitus - Currently taking stable doses of metformin (>=1500 mg/day) and sulfonylurea - Male, or female not of reproductive potential or female of reproductive potential who agrees to remain abstinent or use (or have their partner use) 2 methods of acceptable contraception to prevent pregnancy during the study and for 21 days after the last dose of study drug Exclusion Criteria: - History of type 1 diabetes mellitus or a history of ketoacidosis - Treated with any antihyperglycemic agent therapies other than the protocol-required sulfonylurea and metformin within 12 weeks prior to study participation or with MK-3102 at any time prior to study participation. - History of hypersensitivity to a dipeptidyl peptidase IV (DPP-4) inhibitor - On a weight loss program and is not in the maintenance phase; or has been on a weight loss medication in the past 6 months; or has undergone bariatric surgery within 12 months prior to study participation. - Is on or likely to require treatment for >=2 consecutive weeks or repeated courses of corticosteroids (inhaled, nasal or topical corticosteroids are permitted) - Currently being treated for hyperthyroidism or is on thyroid replacement therapy and has not been on a stable dose for at least 6 weeks - 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 - Poorly controlled hypertension - 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 - Current user of recreational or illicit drugs or has had a recent history of drug abuse or routinely consumes >2 alcoholic drinks per day or >14 drinks per week, or engages in binge drinking - Donated blood products within 8 weeks of study participation, or intends to donate blood products during the study or has received or anticipates receiving blood products within 12 weeks prior to study participation or during the study |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Contact: Toll Free Number 1-888-577-8839 |
| Location Countries | United States, Korea, Republic of, Russian Federation, South Africa |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT01704261 |
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| Other Study ID Numbers | 3102-022 |
| 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 | April 2014 |
Locations[ + expand ][ + ]
| Call for Information (Investigational Site 0002) | Hillsborough, California, United States, 92868 Recruiting |
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| Call for Information (Investigational Site 0001) | Huntingdon Beach, California, United States, 92647 Recruiting |
| Call for Information (Investigational Site 0018) | Tustin, California, United States, 92780 Recruiting |
| Call for Information (Investigational Site 0008) | Ft. Lauderdale, Florida, United States, 33316 Recruiting |
| Call for Information (Investigational Site 0003) | Orlando, Florida, United States, 32825 Recruiting |
| Call for Information (Investigational Site 0006) | Meridian, Idaho, United States, 83646 Recruiting |
| Call for Information (Investigational Site 0015) | LaPorte, Indiana, United States, 46350 Recruiting |
| Call for Information (Investigational Site 0012) | Kalamazoo, Michigan, United States, 49009 Recruiting |
| Call for Information (Investigational Site 0010) | Asheboro, North Carolina, United States, 27203 Recruiting |
| Call for Information (Investigational Site 0011) | Calabash, North Carolina, United States, 28467 Recruiting |
| Call for Information (Investigational Site 0005) | Oklahoma City, Oklahoma, United States, 73139 Recruiting |
| Call for Information (Investigational Site 0004) | Ashland, Oregon, United States, 97520 Recruiting |
| Call for Information (Investigational Site 0016) | San Antonio, Texas, United States, 78258 Recruiting |
| Call for Information (Investigational Site 0021) | Burke, Virginia, United States, 22015 Recruiting |
| Call for Information (Investigational Site 0014) | Selah, Washington, United States, 98942 Recruiting |
| MSD Korea LTD | Seoul, Korea, Republic of Contact: Cem Ozesen | 90 212 3361260Recruiting |
| Merck Sharp & Dohme IDEA, Inc. | Moscow, Russian Federation Contact: Maria Koroleva | 7 0959410000Recruiting |
| MSD (Pty) LTD South Africa | Midrand, South Africa Contact: Khanyi Mzolo | 27 11 655 3140Recruiting |