A Study of the Safety and Efficacy of MK-0431A in Pediatric Participants With Type 2 Diabetes Mellitus (MK-0431A-170 AM1)
Overview[ - collapse ][ - ]
| Purpose | The purpose of the study is to assess the safety of the addition of sitagliptin, and its effect on hemoglobin A1c (A1C), fasting plasma glucose (FPG) and the proportion of patients requiring glycemic rescue therapy in pediatric patients 10-17 years of age (inclusive) with type 2 diabetes mellitus (T2DM) with inadequate glycemic control on metformin monotherapy. |
|---|---|
| Condition | Diabetes Mellitus, Type 2 |
| Intervention | Drug: Metformin Drug: Sitagliptin / Metformin Drug: Placebo to Metformin Drug: Placebo to Sitagliptin / Metformin |
| Phase | Phase 3 |
| Sponsor | Merck Sharp & Dohme Corp. |
| Responsible Party | Merck Sharp & Dohme Corp. |
| ClinicalTrials.gov Identifier | NCT01472367 |
| First Received | November 11, 2011 |
| Last Updated | March 20, 2014 |
| Last verified | March 2014 |
Tracking Information[ + expand ][ + ]
| First Received Date | November 11, 2011 |
|---|---|
| Last Updated Date | March 20, 2014 |
| Start Date | December 2011 |
| Estimated Primary Completion Date | December 2017 |
| 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 in Pediatric Participants With Type 2 Diabetes Mellitus (MK-0431A-170 AM1) |
|---|---|
| Official Title | A Phase III, Multicenter, Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Evaluate the Safety and Efficacy of MK-0431A (A Fixed-Dose Combination Tablet of Sitagliptin and Metformin) in Pediatric Patients With Type 2 Diabetes Mellitus |
| Brief Summary | The purpose of the study is to assess the safety of the addition of sitagliptin, and its effect on hemoglobin A1c (A1C), fasting plasma glucose (FPG) and the proportion of patients requiring glycemic rescue therapy in pediatric patients 10-17 years of age (inclusive) with type 2 diabetes mellitus (T2DM) 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, Caregiver, Investigator), Primary Purpose: Treatment |
| Condition | Diabetes Mellitus, Type 2 |
| Intervention | Drug: Metformin Metformin oral tablets twice a day Participants on a metformin daily dose of 1000, 1250, or 1275 mg at screening will be switched to a metformin daily dose of 1000 mg (500 mg twice a day); 1500, 1700, or 1750 mg will be switched to a metformin daily dose of 1700 mg (850 mg twice a day); 2000 mg or more will be switched to a metformin daily dose of 2000 mg (1000 mg twice a day). Once these adjustments are made participants will enter a 1-week single blind run-in followed by a 20-week treatment period. Total treatment with metformin will be 21 weeks. Other Names: GlucophageDrug: Sitagliptin / Metformin Sitagliptin / metformin oral tablet 50/500, 50/850, or 50/1000 mg dosed twice daily. After the single blind 1-week run-in period patients will be randomized to receive sitagliptin/metformin combination: 50/500, 50/850, or 50/1000 mg twice a day plus placebo to metformin or Metformin 500, 850, or 1000 mg twice a day, plus placebo to sitagliptin/metformin combination. Other Names:
Matching placebo to Metformin twice a day Participants randomized to sitagliptin / metformin combination will take matching placebo to metformin twice a day for 20 weeks. Drug: Placebo to Sitagliptin / Metformin Matching placebo to Sitagliptin / Metformin oral tablet dosed twice daily During the 1-week single blind run-in all participants will take the matching placebo to sitagliptin/metformin combination twice a day. Following randomization participants assigned to metformin treatment arm will take the placebo to sitagliptin/metformin combination twice a day for 20 weeks. |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Recruiting |
|---|---|
| Estimated Enrollment | 240 |
| Estimated Completion Date | December 2017 |
| Estimated Primary Completion Date | December 2017 |
| Eligibility Criteria | Inclusion Criteria: - Has Type 2 Diabetes Mellitus (T2DM) - Has not received treatment with insulin for at least 6 months prior to the Screening Visit/Visit 1. - A1C greater than or equal to 7.0% and less than or equal to 10.0% on metformin, 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 may be eligible if there is documentation that higher doses are not tolerated. - Between 10 and 17 years of age on day of signing informed consent with randomization to occur prior to 18th birthday. - Participant and a family member or adult closely involved in the daily activities will participate in the participant's treatment and study protocol (i.e., available for telephone calls, study visits and administration of study medication as needed). Exclusion Criteria: - Known type 1 diabetes mellitus or documented evidence of positive diabetes auto-antibodies (if performed when patient was diagnosed with diabetes). - Known monogenic diabetes, secondary diabetes, or a genetic syndrome or disorder known to affect glucose tolerance other than diabetes. - Symptomatic hyperglycemia and/or moderate to large ketonuria requiring immediate initiation of another antihyperglycemic agent. - Participant has previously taken a DPP-4 inhibitor (such as sitagliptin, vildagliptin,alogliptin, or saxagliptin) or GLP-1 receptor agonist (such as exenatide or liraglutide). - Exhibits abnormal growth patterns or is being treated with growth hormone. - History of idiopathic acute pancreatitis or chronic pancreatitis. |
| Gender | Both |
| Ages | 10 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Contact: Toll Free Number 1-888-577-8839 |
| Location Countries | United States, Argentina, Bulgaria, Canada, Chile, Colombia, Dominican Republic, Germany, Guatemala, Israel, Italy, Latvia, Lithuania, Malaysia, Mexico, New Zealand, Romania, Russian Federation, Saudi Arabia, Thailand, United Arab Emirates, United Kingdom |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT01472367 |
|---|---|
| Other Study ID Numbers | 0431A-170 |
| 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 |
Locations[ + expand ][ + ]
| Call for Information (Investigational Site 0101) | Canoga Park, California, United States, 91303 Recruiting |
|---|---|
| Call for Information (Investigational Site 0015) | Clovis, California, United States, 93612 Recruiting |
| Call for Information (Investigational Site 0020) | Los Angeles, California, United States, 90048 Recruiting |
| Call for Information (Investigational Site 0022) | Sacramento, California, United States, 95821 Recruiting |
| Call for Information (Investigational Site 0021) | San Diego, California, United States, 92123 Recruiting |
| Call for Information (Investigational Site 0024) | Aurora, Colorado, United States, 80045 Recruiting |
| Call for Information (Investigational Site 0300) | Miami Lakes, Florida, United States, 33014 Recruiting |
| Call for Information (Investigational Site 0301) | Iowa City, Iowa, United States, 52242 Recruiting |
| Call for Information (Investigational Site 0012) | Portland, Maine, United States, 04102 Recruiting |
| Call for Information (Investigational Site 0014) | Rochester, New York, United States, 14642 Recruiting |
| Call for Information (Investigational Site 0017) | Boerne, Texas, United States, 78006 Recruiting |
| Call for Information (Investigational Site 0019) | Houston, Texas, United States, 77081 Recruiting |
| Call for Information (Investigational Site 0010) | San Antonio, Texas, United States, 78229 Recruiting |
| Merck Sharp & Dohme (Argentina) Inc. | Buenos Aires, Argentina Contact: Alfredo Wilkinson | 54 11 4796 8200Recruiting |
| Merck Sharp & Dohme Bulgaria EOOD | Sofia, Bulgaria Contact: Eran Gefen | 38 (044) 393 74 80Recruiting |
| 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 & Dohme | Santo Domingo, Dominican Republic Contact: Felipe Arbelaez | (787) 474-8200Recruiting |
| Merck Sharp & Dohme GmbH | Haar, Germany Contact: German Medical Information Center | 49 800 673 673 673Recruiting |
| MSD CARD | Guatemala, Guatemala Contact: Soraya Cedraro | 507-282-7200Recruiting |
| 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 |
| Merck Sharp & Dohme Latvija SIA | Riga, Latvia Contact: Andrius Bacevicius | 370 52780243Recruiting |
| UAB "Merck Sharp & Dohme" | Vilnius, Lithuania Contact: Andrius Bacevicius | 370 52780243Recruiting |
| MSD | Petaling Jaya, Malaysia Contact: Boon Hock Yeoh | 60 377181723Recruiting |
| MSD | Mexico City, Mexico Contact: Juan Marques | 52 55254819608Recruiting |
| Merck Sharp & Dohme (New Zealand) Ltd., | Wellington, New Zealand Contact: Gary Jankelowitz | 61 2 8988 8246Recruiting |
| 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 |
| MSD (IA) Corp - SA Branch | Riyadh, Saudi Arabia Contact: Samer El-Ali | 04 4269100Recruiting |
| MSD (Thailand) Ltd. | Bangkok, Thailand Contact: Thanu Komolsai | 66 2262 5746Recruiting |
| Merck Sharp & Dohme | Dubai, United Arab Emirates Contact: Vikram Singh | 971 44 269184Recruiting |
| Merck Sharp & Dohme Ltd. | Hoddesdon, United Kingdom Contact: Paul Robinson | 44 1992452396Recruiting |