A Study of the Safety and Efficacy of MK-3102 in ≥18 and <45 Year-Old Subjects With Type 2 Diabetes Mellitus and Inadequate Glycemic Control (MK-3102-028 AM1)
Overview[ - collapse ][ - ]
| Purpose | This study will examine the safety and efficacy of once-weekly MK-3102 in participants 18 to <45 years of age with Type 2 diabetes mellitus and inadequate glycemic control. The study hypothesis is that treatment with MK-3102 compared with placebo provides greater reduction in hemoglobin A1c (A1C) in participants after 24 weeks. |
|---|---|
| Condition | Diabetes Mellitus |
| Intervention | Drug: MK-3102 Drug: Placebo to MK-3102 Drug: Metformin |
| Phase | Phase 3 |
| Sponsor | Merck Sharp & Dohme Corp. |
| Responsible Party | Merck Sharp & Dohme Corp. |
| ClinicalTrials.gov Identifier | NCT01814748 |
| First Received | March 18, 2013 |
| Last Updated | April 1, 2014 |
| Last verified | April 2014 |
Tracking Information[ + expand ][ + ]
| First Received Date | March 18, 2013 |
|---|---|
| Last Updated Date | April 1, 2014 |
| Start Date | May 2013 |
| Estimated Primary Completion Date | March 2016 |
| Current Primary Outcome Measures |
|
| Current Secondary Outcome Measures |
|
Descriptive Information[ + expand ][ + ]
| Brief Title | A Study of the Safety and Efficacy of MK-3102 in ≥18 and <45 Year-Old Subjects With Type 2 Diabetes Mellitus and Inadequate Glycemic Control (MK-3102-028 AM1) |
|---|---|
| Official Title | A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety and Efficacy of MK-3102 in ≥18 and <45 Year-Old Subjects With Type 2 Diabetes Mellitus and Inadequate Glycemic Control |
| Brief Summary | This study will examine the safety and efficacy of once-weekly MK-3102 in participants 18 to <45 years of age with Type 2 diabetes mellitus and inadequate glycemic control. The study hypothesis is that treatment with MK-3102 compared with placebo provides greater reduction in hemoglobin A1c (A1C) in participants after 24 weeks. |
| 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 | Diabetes Mellitus |
| Intervention | Drug: MK-3102 MK-3102 25 mg capsule administered orally once weekly Drug: Placebo to MK-3102 Matching placebo to MK-3102 25 mg capsule administered orally once weekly Drug: Metformin Participants exceeding pre-specified glycemic thresholds during the double-blind treatment period will receive rescue therapy with open-label metformin. Other Names:
|
| Study Arm (s) |
|
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Recruiting |
|---|---|
| Estimated Enrollment | 200 |
| Estimated Completion Date | March 2016 |
| Estimated Primary Completion Date | March 2016 |
| Eligibility Criteria | Inclusion Criteria: - Has type 2 diabetes mellitus - Currently not on an antihyperglycemic agent (AHA) for at least the past 12 weeks and has not been treated with MK-3102 at any time prior to study participation - Participant is one of the following: 1. Male 2. Female who is not of reproductive potential 3. Female of reproductive potential who agrees to remain abstinent from heterosexual activity or use (or have her partner use) 2 acceptable methods of 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 - History of hypersensitivity to dipeptidyl-peptidase-4 (DPP-4) inhibitor - Currently participating in or has participated in a clinical trial in the past 12 weeks - Is on a weight loss program and not in the maintenance phase; has been on a weight loss medication in the past 6 months; or has undergone bariatric surgery within 12 months prior to study participation - Has undergone a surgical procedure within 4 weeks of study participation or has planned major surgery during the study - Is on or likely to require treatment for ≥14 consecutive days or repeated courses of pharmacologic doses of corticosteroids - Is currently being treated for hyperthyroidism or is on thyroid replacement therapy and has not been on a stable dose for at least 6 weeks - Is expecting to undergo hormonal therapy in preparation to donate eggs during the study, including 21 days following the last dose of study drug - 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 - Has human immunodeficiency virus (HIV) - Has had new or worsening coronary heart disease or congestive heart failure within the past 3 months, or has any of the following disorders within the past 3 months: 1. Acute coronary syndrome 2. Coronary artery intervention 3. Stroke or transient ischemic neurological disorder - Has poorly controlled hypertension - History of malignancy ≤5 years prior to study participation, except for basal cell or squamous cell skin cancer or in situ cervical cancer - Has a hematological disorder (such as aplastic anemia, myeloproliferative or myelodysplastic syndromes, thrombocytopenia) - Has a positive urine pregnancy test - Pregnant or breastfeeding, or is expecting to conceive during the study, including 21 days following the last dose of study drug - User of recreational or illicit drugs or has had a recent history of drug abuse. Routinely consumes >2 alcoholic drinks per day or >14 alcoholic drinks per week, or engages in binge drinking. - Has donated blood products or has had a phlebotomy (>300 mL) within 8 weeks of study participation, or intends to donate blood products during the study or has received, or is anticipated to receive, blood products within 12 weeks of study participation or during the study - Has a clinically significant electrocardiogram abnormality |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Contact: Toll Free Number 1-888-577-8839 |
| Location Countries | United States, Romania, Russian Federation, Serbia, South Africa, Ukraine |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT01814748 |
|---|---|
| Other Study ID Numbers | 3102-028 |
| 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 0008) | Boca Raton, Florida, United States, 33432 Recruiting |
|---|---|
| Call for Information (Investigational Site 0014) | Hialeah, Florida, United States, 33012 Recruiting |
| Call for Information (Investigational Site 0003) | Manning, Florida, United States, 29102 Recruiting |
| Call for Information (Investigational Site 0007) | Dearborn, Michigan, United States, 48124 Recruiting |
| Call for Information (Investigational Site 0016) | Greensboro, North Carolina, United States, 27405 Recruiting |
| Call for Information (Investigational Site 0010) | Houston, Texas, United States, 77055 Recruiting |
| Call for Information (Investigational Site 0011) | Houston, Texas, United States, 77043 Recruiting |
| Merck Sharp & Dohme Romania SRL | Bucharest, Romania Contact: Eran Gefen | 38 (044) 393 74 80Recruiting |
| Merck Sharp & Dohme IDEA, Inc. | Moscow, Russian Federation Contact: Maria Koroleva | 7 0959410000Recruiting |
| Merck Sharp & Dohme | Belgrade, Serbia Contact: Eran Gefen | 38 (044) 393 74 80Recruiting |
| MSD (Pty) LTD South Africa | Midrand, South Africa Contact: Khanyi Mzolo | 27 11 655 3140Recruiting |
| MSD Ukraine LLC | Kiev, Ukraine Contact: Eran Gefen | 38 (044) 393 74 80Recruiting |