A Study to Assess the Safety and Efficacy of MK-3102 in Participants With Type 2 Diabetes Mellitus (T2DM) and Inadequate Glycemic Control (MK-3102-011)
Overview[ - collapse ][ - ]
Purpose | The purpose of this study is to assess the safety and efficacy of MK-3102, dosed once-weekly in participants with T2DM who have inadequate glycemic control on diet and exercise. The primary hypothesis is that after 24 weeks, treatment with MK-3102 compared with placebo provides greater reduction in hemoglobin A1c (A1C). |
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Condition | Type 2 Diabetes Mellitus |
Intervention | Drug: MK-3102 Drug: Placebo to MK-3012 Drug: Metformin Drug: Placebo to metformin Drug: Glimepiride |
Phase | Phase 3 |
Sponsor | Merck Sharp & Dohme Corp. |
Responsible Party | Merck Sharp & Dohme Corp. |
ClinicalTrials.gov Identifier | NCT01717313 |
First Received | October 26, 2012 |
Last Updated | April 21, 2014 |
Last verified | April 2014 |
Tracking Information[ + expand ][ + ]
First Received Date | October 26, 2012 |
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Last Updated Date | April 21, 2014 |
Start Date | December 2012 |
Estimated Primary Completion Date | April 2015 |
Current Primary Outcome Measures |
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Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
Brief Title | A Study to Assess the Safety and Efficacy of MK-3102 in Participants With Type 2 Diabetes Mellitus (T2DM) and Inadequate Glycemic Control (MK-3102-011) |
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Official Title | A Multicenter, Phase III, Randomized, Placebo-controlled Trial to Assess the Safety and Efficacy of MK-3102 Monotherapy in Subjects With Type 2 Diabetes Mellitus and Inadequate Glycemic Control |
Brief Summary | The purpose of this study is to assess the safety and efficacy of MK-3102, dosed once-weekly in participants with T2DM who have inadequate glycemic control on diet and exercise. The primary hypothesis is that after 24 weeks, treatment with MK-3102 compared with placebo provides greater reduction in hemoglobin A1c (A1C). |
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: Placebo to MK-3012 Placebo to MK-3102 capsule administered orally once a week Drug: Metformin If necessary, participants may have glycemic rescue therapy initiated with open-label metformin during Phase A of the study. Participants in the placebo treatment group who were not rescued with open-label metformin during Phase A will receive blinded metformin (starting at 500 mg orally twice daily with up-titration to 1000 mg orally twice daily) in Phase B. Participants in the MK-3102 treatment group who were rescued with open-label metformin in Phase A will continue open-label metformin during Phase B of the study. Other Names:
During Phase B of the study, participants in the MK-3102 treatment group who did not initiate glycemic rescue therapy during Phase A will receive placebo to metformin for 30 weeks (Phase B of the study). Drug: Glimepiride If necessary during Phase B of the study, participants will initiate open-label glimepiride as glycemic therapy Other Names: Armaryl® |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Recruiting |
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Estimated Enrollment | 300 |
Estimated Completion Date | April 2015 |
Estimated Primary Completion Date | April 2015 |
Eligibility Criteria | Inclusion Criteria: - Has type 2 diabetes mellitus - Participants in India must be ≤65 years of age - Meets one of the following criteria: currently not on an antihyperglycemic agent (AHA) for >= 12 weeks and has an A1C of >=7% and <=10% or on stable monotherapy or low-dose combination therapy for > 12 weeks and has an A1C of >=6.5% and <=9% - Participant is one of the following: male, female who is not of reproductive potential, female of reproductive potential who agrees to remain abstinent from heterosexual activity or use (or have their partner use) 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 - Has been treated with: a thiazolidinedione (TZD) within 4 months of study participation, a glucagon-like peptide-1 (GLP-1) receptor mimetic or agonist or dipeptidyl peptidase IV (DPP-4) inhibitor within 6 months of study participation, insulin or sodium-glucose cotransporter inhibitor within 12 weeks of study participation, MK-3102 at any time prior to study participation - History of hypersensitivity to DPP-4 inhibitor - History of intolerance, hypersensitivity or any contraindication to metformin and/or glimepiride or other sulfonylurea - Is on a weight loss program and 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 - 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 corticosteroids (inhaled, nasal and topical corticosteroids are permitted) - Is currently being treated for hyperthyroidism or is on thyroid hormone 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 steatosis) including chronic active hepatitis B or C, primary biliary cirrhosis, or symptomatic gallbladder disease - 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: acute coronary syndrome, coronary artery intervention, 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 - Hematological disorder (such as aplastic anemia, myeloproliferative or myelodysplastic syndromes, thrombocytopenia) - 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 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 |
Gender | Both |
Ages | 18 Years |
Accepts Healthy Volunteers | No |
Contacts | Contact: Toll Free Number 1-888-577-8839 |
Location Countries | United States, Bulgaria, Germany, Hungary, Italy, Korea, Republic of, Netherlands, Philippines, Romania, Taiwan |
Administrative Information[ + expand ][ + ]
NCT Number | NCT01717313 |
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Other Study ID Numbers | 3102-011 |
Has Data Monitoring Committee | Yes |
Information Provided By | Merck Sharp & Dohme Corp. |
Study Sponsor | Merck Sharp & Dohme Corp. |
Collaborators | Not Provided |
Investigators | Study Director: Medical Director Merck Sharp & Dohme Corp. |
Verification Date | April 2014 |
Locations[ + expand ][ + ]
Call For Information (Investigational Site 0001) | Oklahoma City, Oklahoma, United States, 73139 Contact: Toll Free Number | 888-577-8839Recruiting |
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Merck Sharp & Dohme Bulgaria EOOD | Sofia, Bulgaria Contact: Eran Gefen | 38 (044) 393 74 80Recruiting |
Merck Sharp & Dohme GmbH | Haar, Germany Contact: German Medical Information Center | 49 800 673 673 673Recruiting |
MSD Pharma Hungary Kft. | Budapest, Hungary Contact: Simona Martinkova | 36 1 457 8522Recruiting |
MSD Italia S.r.l. | Rome, Italy Contact: Patrizia Nardini | 39 06 361911Recruiting |
MSD Korea LTD | Seoul, Korea, Republic of Contact: Cem Ozesen | 90 212 3361260Recruiting |
Merck Sharp & Dohme BV | Haarlem, Netherlands Contact: Caroline Doornebos | 31 23 515 3362Recruiting |
Merck Sharp & Dohme (I.A.) Corporation | Makati, Philippines Contact: Cesar Recto | 632 784 9500Recruiting |
Merck Sharp & Dohme Romania SRL | Bucharest, Romania Contact: Eran Gefen | 38 (044) 393 74 80Recruiting |
Merck Sharp & Dohme (I.A.) Corp. | Taipei, Taiwan Contact: Diana Zhang | 886-2-66316030Recruiting |