Study to Assess Safety & Efficacy of Sitagliptin as Initial Monotherapy for Treatment of Type 2 Diabetes Mellitus in Pediatric Participants (MK-0431-083)
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) in pediatric participants 10-17 years of age with type 2 diabetes mellitus (T2DM) with inadequate glycemic control. The primary hypothesis for this study is that sitagliptin reduces A1C more than placebo after 20 weeks of treatment. |
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Condition | Diabetes Mellitus Type 2 Diabetes |
Intervention | Drug: Sitagliptin Drug: Metformin Drug: Placebo to sitagliptin Drug: Placebo to metformin Drug: Metformin Rescue Drug: Sitagliptin Rescue Biological: Insulin Rescue |
Phase | Phase 3 |
Sponsor | Merck Sharp & Dohme Corp. |
Responsible Party | Merck Sharp & Dohme Corp. |
ClinicalTrials.gov Identifier | NCT01485614 |
First Received | December 1, 2011 |
Last Updated | April 17, 2014 |
Last verified | April 2014 |
Tracking Information[ + expand ][ + ]
First Received Date | December 1, 2011 |
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Last Updated Date | April 17, 2014 |
Start Date | February 2012 |
Estimated Primary Completion Date | November 2017 |
Current Primary Outcome Measures |
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Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
Brief Title | Study to Assess Safety & Efficacy of Sitagliptin as Initial Monotherapy for Treatment of Type 2 Diabetes Mellitus in Pediatric Participants (MK-0431-083) |
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Official Title | A Phase III, Multicenter, Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Evaluate the Safety and Efficacy of Sitagliptin in Pediatric Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control |
Brief Summary | The purpose of the study is to assess the safety of the addition of sitagliptin, and its effect on hemoglobin A1c (A1C) in pediatric participants 10-17 years of age with type 2 diabetes mellitus (T2DM) with inadequate glycemic control. The primary hypothesis for this study is that sitagliptin reduces A1C more than placebo after 20 weeks of treatment. |
Detailed Description | This trial is of approximately 56 weeks in duration, including a screening period of up to 1 week, a 1-week single-blind placebo run-in period, a 20-week placebo-controlled, double blind treatment period [Phase A] and a 34-week double-blind active controlled treatment period [Phase B] during which participants randomized to the placebo arm who have not initiated glycemic rescue therapy with metformin during Phase A will receive metformin (in a blinded manner). A telephone contact will be performed 14 days after the last dose of study medication to assess for any serious adverse events (SAEs). Two arms of the study were removed from the study by a protocol amendment. |
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 |
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Intervention | Drug: Sitagliptin 100 mg oral tablet of sitagliptin prior to the morning meal in Phase A and Phase B. Other Names: JanuviaDrug: Metformin Metformin (500 mg), 2 tablets twice daily prior to morning and evening meals Other Names: GlucophageDrug: Placebo to sitagliptin After randomization: Participants randomized to the Placebo Phase A/Metformin Phase B arm will receive 1 oral tablet of placebo to sitagliptin prior to the morning meal. Phase B: Participants in the Placebo Phase A/Metformin Phase B arm will continue to receive 1 oral tablet of placebo to sitagliptin prior to the morning meal. For 1 week, participants will receive 1 oral tablet of placebo to sitagliptin prior to the morning meal. Drug: Placebo to metformin After randomization: Participants randomized to the Sitagliptin Arm and those randomized to the Placebo Phase A/Metformin Phase B arm will receive 2 oral tablets of placebo to metformin prior to the morning and evening meals. Phase B: Participants in the Sitagliptin Arm will continue to receive 2 oral tablets of placebo to metformin prior to the morning and evening meals. For 1 week participants will receive oral tablets of placebo to metformin (500 mg), 2 tablets prior to the morning and evening meals. Drug: Metformin Rescue Mandatory glycemic rescue will be initiated in both Phase A and Phase B for participants meeting defined glycemic thresholds. For Rescue Step 1 (blinded), eligible participants receiving sitagliptin or placebo (in Phase A), or sitagliptin (in Phase B) will initiate metformin. Drug: Sitagliptin Rescue Mandatory glycemic rescue will be initiated in both Phase A and Phase B for participants meeting defined glycemic thresholds. For Rescue Step 1 (blinded), eligible participants receiving metformin (in Phase B) will initiate sitagliptin. Biological: Insulin Rescue Mandatory glycemic rescue will be initiated in both Phase A and Phase B for participants meeting defined glycemic thresholds. For Rescue Step 2 (open-label), participants receiving sitagliptin, placebo or metformin will receive insulin according to routine clinical practice. |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Recruiting |
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Estimated Enrollment | 170 |
Estimated Completion Date | November 2017 |
Estimated Primary Completion Date | November 2017 |
Eligibility Criteria | Inclusion Criteria: - Type 2 Diabetes Mellitus (T2DM) - Has not received treatment with an oral antihyperglycemic agent (AHA) or insulin for ≥12 weeks prior to the Screening Visit/Visit 1. - An A1C of ≥6.5% and ≤10.0%. Exclusion Criteria: - History of type 1 diabetes mellitus, autoimmune diabetes mellitus or has a positive antibody screen for anti-GAD (Glutamic Acid Decarboxylase) or (Islet cell autoantigen) ICA-512. - 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 and/or positive test for ketonemia requiring immediate initiation of antihyperglycemic therapy. - Previously taken a DPP-4 (Dipeptidyl peptidase-4) inhibitor (such as sitagliptin, vildagliptin, alogliptin, or saxagliptin) or (Glucagon-like peptide-1) GLP-1 receptor agonist (such as exenatide or liraglutide). - Hypersensitivity or contraindication (according to the product circular in the country of the investigational site) to metformin. - Chronic treatment with a medication known to cause weight gain within 30 days of study start or weight loss or increased blood glucose within 8 weeks of study start or treated with an anti-psychotic within the past 12 weeks. - On a weight loss program and not in the maintenance phase or have undergone bariatric surgery within 12 months prior to study start. - On or likely to require treatment with ≥14 consecutive days or repeated courses of pharmacologic doses of corticosteroids. - Undergone a surgical procedure within the prior 4 weeks or has major surgery planned during the study. - History of congenital heart disease or cardiovascular disease other than hypertension. - 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. - Active nephropathy (i.e., nephrotic syndrome or glomerulonephritis). - Chronic myopathy, mitochondrial disorder, or a progressive neurological or neuromuscular disorder (e.g., polymyositis, or multiple sclerosis). - Human immunodeficiency virus (HIV) as assessed by medical history. - Clinically significant hematological disorder (such as aplastic anemia, thrombocytopenia, myeloproliferative or myelodysplastic syndrome). - Under treatment for hyperthyroidism. - Exhibits abnormal growth patterns or is being treated with growth hormone. - History of malignancy or clinically important hematologic disorder. - History of idiopathic acute pancreatitis or chronic pancreatitis. - Known history of recreational or illicit drug use, or of alcohol abuse or dependence (within the past year). - Donated blood products or has had phlebotomy of >10% of estimated total blood volume within 8 weeks of signing informed consent, or intends to donate blood products or receive blood products within the projected duration of the study. - Pregnant, has a positive urine pregnancy test at Screening Visit/Visit 1, is expecting to conceive within the projected duration of the study, or is breast-feeding. - Exclusionary laboratory values. - 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, Australia, Austria, Bulgaria, Canada, Chile, Colombia, Denmark, Dominican Republic, Germany, Guatemala, Hungary, Israel, Italy, Latvia, Lithuania, Malaysia, Mexico, New Zealand, Panama, Poland, Romania, Russian Federation, Slovakia, Spain, Sweden, Thailand |
Administrative Information[ + expand ][ + ]
NCT Number | NCT01485614 |
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Other Study ID Numbers | 0431-083 |
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 (Investigative Site 0312) | Birmingham, Alabama, United States, 35233-1711 Recruiting |
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Call for Information (Investigational Site 0312) | Birmingham, Alabama, United States, 35233-1711 Recruiting |
Call for Information (Investigational Site 0316) | Phoenix, Arizona, United States, 85048 Recruiting |
Call for Information (Investigational Site 0317) | Phoenix, Arizona, United States, 85016 Recruiting |
Call for Information (Investigational Site 0012) | Canoga Park, California, United States, 91303 Recruiting |
Call for Information (Investigational Site 0013) | Clovis, California, United States, 93612 Recruiting |
Call for Information (Investigational Site 0018) | Los Angeles, California, United States, 90048 Recruiting |
Call for Information (Investigational Site 0020) | Sacramento, California, United States, 95821 Recruiting |
Call for Information (Investigational Site 0019) | San Diego, California, United States, 92123 Recruiting |
Call for Information (Investigational Site 0334) | San Diego, California, United States, 92102 Recruiting |
Call for Information (Investigational Site 0307) | Ventura, California, United States, 93003 Recruiting |
Call for Information (Investigational Site 0023) | Aurora, Colorado, United States, 80045 Recruiting |
Call for Information (Investigational Site 0325) | Atlanta, Georgia, United States, 30342 Recruiting |
Call for Information (Investigational Site 0326) | Thomaston, Georgia, United States, 30286 Recruiting |
Call for Information (Investigational Site 0303) | Louisville, Kentucky, United States, 40202 Recruiting |
Call for Information (Investigational Site 0009) | Portland, Maine, United States, 04102 Recruiting |
Call for Information (Investigational Site 0305) | Baltimore, Maryland, United States, 21215 Recruiting |
Call for Information (Investigational Site 0309) | Neptune, New Jersey, United States, 07753 Recruiting |
Call for Information (Investigational Site 0310) | Lake Success, New York, United States, 11042 Recruiting |
Call for Information (Investigational Site 0011) | Rochester, New York, United States, 14642 Recruiting |
Call for Information (Investigational Site 0014) | Akron, Ohio, United States, 44308 Recruiting |
Call for Information (Investigational Site 0090) | Canal Fulton, Ohio, United States, 44614 Recruiting |
Call for Information (Investigational Site 0096) | Toledo, Ohio, United States, 43606 Recruiting |
Call for Information (Investigational Site 0324) | Lebanon, Tennessee, United States, 37087 Recruiting |
Call for Information (Investigational Site 0015) | Boerne, Texas, United States, 78006 Recruiting |
Call for Information (Investigational Site 0322) | Edinburg, Texas, United States, 78539 Recruiting |
Call for Information (Investigational Site 0017) | Houston, Texas, United States, 77081 Recruiting |
Call for Information (Investigational Site 0006) | 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 | North Ryde, Australia Contact: Gary Jankelowitz | 61 2 8988 8246Recruiting |
MSD ýterreich GmbH | Vienna, Austria Contact: Karl Boegl | 43 126044130Recruiting |
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 | Glostrup, Denmark Contact: Gert Andersen | 45 44824475Recruiting |
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 |
MSD Pharma Hungary Kft. | Budapest, Hungary Contact: Simona Martinkova | 36 1 457 8522Recruiting |
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 |
MSD CARD | Panama, Panama Contact: Soraya Cedraro | 507-282-7200Recruiting |
MSD Polska Sp. Z o.o. | Warsaw, Poland Contact: Adam Czernik | 48 22 4784324Recruiting |
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 S.R.O. | Bratislava, Slovakia Contact: Eva Kaszasova | 420 233010213Recruiting |
Merck Sharp and Dohme de Espana S.A. | Madrid, Spain Contact: Cesar Sanz Rodriguez | 34 913210600Recruiting |
MSD | Sollentuna, Sweden Contact: Tryggve Ljung | 46 (0)70 545 28 66Recruiting |
MSD (Thailand) Ltd. | Bangkok, Thailand Contact: Thanu Komolsai | 66 2262 5746Recruiting |