A Study of the Safety and Efficacy of MK-0431A XR in Pediatric Participants With Type 2 Diabetes Mellitus (MK-0431A-289 AM2)
Overview[ - collapse ][ - ]
| Purpose | The purpose of this study is to assess the safety and efficacy of the addition of sitagliptin (administered as MK-0431A XR) compared with the addition of placebo to therapy with extended-release metformin (metformin XR) for the treatment of type 2 diabetes mellitus (T2DM) in pediatric participants with inadequate glycemic control on metformin monotherapy. The primary hypothesis is that the addition of sitagliptin reduces hemoglobin A1c (A1C) more than the addition of placebo after 20 weeks of treatment. |
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| Condition | Type 2 Diabetes Mellitus |
| Intervention | Drug: MK-0431A XR Drug: Placebo to MK-0431A XR Drug: Metformin XR Drug: Placebo to metformin XR Drug: Insulin glargine |
| Phase | Phase 3 |
| Sponsor | Merck Sharp & Dohme Corp. |
| Responsible Party | Merck Sharp & Dohme Corp. |
| ClinicalTrials.gov Identifier | NCT01760447 |
| First Received | January 2, 2013 |
| Last Updated | April 1, 2014 |
| Last verified | April 2014 |
Tracking Information[ + expand ][ + ]
| First Received Date | January 2, 2013 |
|---|---|
| Last Updated Date | April 1, 2014 |
| Start Date | February 2013 |
| Estimated Primary Completion Date | September 2016 |
| Current Primary Outcome Measures |
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| Current Secondary Outcome Measures | Not Provided |
Descriptive Information[ + expand ][ + ]
| Brief Title | A Study of the Safety and Efficacy of MK-0431A XR in Pediatric Participants With Type 2 Diabetes Mellitus (MK-0431A-289 AM2) |
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| Official Title | A Phase III Multicenter, Double-blind, Randomized, Placebo-controlled Clinical Trial to Evaluate the Safety and Efficacy of MK-0431A XR (a Fixed-dose Combination Tablet of Sitagliptin and Extended-release Metformin) in Pediatric Subjects With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin Monotherapy |
| Brief Summary | The purpose of this study is to assess the safety and efficacy of the addition of sitagliptin (administered as MK-0431A XR) compared with the addition of placebo to therapy with extended-release metformin (metformin XR) for the treatment of type 2 diabetes mellitus (T2DM) in pediatric participants with inadequate glycemic control on metformin monotherapy. The primary hypothesis is that the addition of sitagliptin reduces hemoglobin A1c (A1C) more than the addition of placebo after 20 weeks of treatment. |
| 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-0431A XR MK-0431A XR fixed-dose combination tablet (sitagliptin/metformin: 50/500 mg, 50/1000 mg) administered prior to the morning meal Drug: Placebo to MK-0431A XR Matching placebo to MK-0431A XR fixed-dose combination tablet administered prior to the morning meal Drug: Metformin XR Metformin XR tablet (500 mg, 1000 mg) administered prior to the morning meal Other Names: Glucophage® XRDrug: Placebo to metformin XR Matching placebo to metformin XR tablet administered prior to the morning meal Drug: Insulin glargine The insulin regimen and dosing will be at the discretion of the investigator (based on locally accepted, national, or international guidelines for the indication and use of insulin glargine) Other Names: Lantus |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Recruiting |
|---|---|
| Estimated Enrollment | 240 |
| Estimated Completion Date | September 2016 |
| Estimated Primary Completion Date | January 2016 |
| Eligibility Criteria | Inclusion Criteria: - Has T2DM - Has not received treatment with insulin for at least 6 months prior to study participation - A1C greater than or equal to 7.0% and less than or equal to 10.0% on metformin immediate release (IR) or extended release (ER), greater than or equal to 1500 mg/day, for greater than or equal to 12 weeks. NOTE: Participants on a daily dose of metformin greater than or equal to 1000 mg/day, but less than 1500 mg/day for greater than or equal to 12 weeks may be eligible if there is documentation that higher doses are not tolerated. - Between 10 and 17 years of age (inclusive) - Male, or female who is unlikely to conceive (non-sterilized, and is not sexually active or agrees to abstain from heterosexual activity or agrees to use an adequate method of contraception) during the study and for 14 days after the last dose of study drug Exclusion Criteria: - Has type 1 diabetes mellitus - Has monogenic diabetes or secondary diabetes - Has previously taken a dipeptidyl peptidase IV (DPP-4) inhibitor (such as sitagliptin, vildagliptin, alogliptin, saxagliptin, or linagliptin) or glucagon-like peptide-1 (GLP-1) receptor agonist (such as exenatide or liraglutide) - Is on or likely to require treatment for > or =2 consecutive weeks or repeated courses of corticosteroids (inhaled, nasal and topical corticosteroids are permitted) - Has undergone a surgical procedure within 4 weeks of study participation or has planned major surgery during the study - History of congenital heart disease or cardiovascular disease other than hypertension - History of active liver disease (other than non-alcoholic steatosis), including chronic active hepatitis B or C, primary biliary cirrhosis, or symptomatic gallbladder disease - Active neuropathy (such as nephrotic syndrome or glomerulonephritis) - Chronic myopathy, mitochondrial disorder or a progressive neurological or neuromuscular disorder - Human immunodeficiency virus (HIV) - Hematological disorder (such as aplastic anemia, thrombocytopenia, myeloproliferative or myelodysplastic syndromes) - 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 - History of malignancy for < or =5 years prior to study participation, except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer - History of idiopathic acute pancreatitis or chronic pancreatitis - History of recreational or illicit drug use, or of alcohol abuse or dependence (within the past year) - Has donated blood products or has had phlebotomy of >10% of estimated total blood volume within 8 weeks of study participation, or intends to donate blood products or receive blood products within the projected duration of the study - Is pregnant or breast-feeding, or is expecting to conceive or donate eggs during the study, including 14 days following the last dose of study drug |
| Gender | Both |
| Ages | 10 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Contact: Toll Free Number 1-888-577-8839 |
| Location Countries | United States, Australia, Canada, Chile, Colombia, Czech Republic, Denmark, Israel, Italy, Mexico, Panama, Philippines, Russian Federation, South Africa |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT01760447 |
|---|---|
| Other Study ID Numbers | 0431A-289 |
| 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 0450) | Birmingham, Alabama, United States, 35233-1711 Recruiting |
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| Call for Information (Investigational Site 0735) | Phoenix, Arizona, United States, 85016 Recruiting |
| Call for Information (Investigational Site 0750) | San Diego, California, United States, 92102 Recruiting |
| Call for Information (Investigational Site 0468) | Ventura, California, United States, 93003 Recruiting |
| Call for Information (Investigational Site 0457) | Ventura, California, United States, 93003 Recruiting |
| Call for Information (Investigational Site 0463) | Jacksonville, Florida, United States, 32207 Recruiting |
| Call for Information (Investigational Site 0452) | Miami Lakes, Florida, United States, 33014 Recruiting |
| Call for Information (Investigational Site 0461) | Tampa, Florida, United States, 33612 Recruiting |
| Call for Information (Investigational Site 0742) | Chicago, Illinois, United States, 60643 Recruiting |
| Call for Information (Investigational Site 0737) | Topeka, Kansas, United States, 66606 Recruiting |
| Call for Information (Investigational Site 0465) | Louisville, Kentucky, United States, 40202 Recruiting |
| Call for Information (Investigational Site 0466) | Boston, Massachusetts, United States, 02115 Recruiting |
| Call for Information (Investigational Site 0470) | Neptune, New Jersey, United States, 07753 Recruiting |
| Call for Information (Investigational Site 0472) | Lake Success, New York, United States, 11042 Recruiting |
| Call for Information (Investigational Site 0473) | Lebanon, Tennessee, United States, 37087 Recruiting |
| Call for Information (Investigational Site 0740) | Edinburg, Texas, United States, 78539 Recruiting |
| Call for Information (Investigational Site 0456) | Fort Worth, Texas, United States, 76104 Recruiting |
| Merck Sharp & Dohme | North Ryde, Australia Contact: Gary Jankelowitz | 61 2 8988 8246Recruiting |
| Merck Canada | Kirkland, Quebec, Canada, H9H 3L1 Contact: Medical Information Centre / Centre de l'information medicale de Merck Canada | 514-428-8600 / 1-800-567-2594Recruiting |
| Merck Sharp & Dohme (I.A.) Corp. | Santiago, Chile Contact: Maria Elena Azara Hernandez | 56 2 6558958Recruiting |
| MDS Colombia SAS | Bogota, Colombia Contact: Francesca Carvajal | 57 1219109011090Recruiting |
| Merck Sharp and Dohme s.r.o. | Praha, Czech Republic Contact: Simona Martinkova | 420 233010213Recruiting |
| Merck Sharp & Dohme | Glostrup, Denmark Contact: Gert Andersen | 45 44824475Recruiting |
| Merck Sharp & Dohme Co. Ltd. | Hod Hasharon, Israel Contact: Ofer Sharon | 972 9 9539310Recruiting |
| MSD Italia S.r.l. | Rome, Italy Contact: Patrizia Nardini | 39 06 361911Recruiting |
| MSD | Mexico City, Mexico Contact: Juan Marques | 52 55254819608Recruiting |
| MSD CARD | Panama, Panama Contact: Soraya Cedraro | 507-282-7200Recruiting |
| Merck Sharp & Dohme (I.A.) Corporation | Makati, Philippines Contact: Cesar Recto | 632 784 9500Recruiting |
| 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 |