A Pilot Study to Assess the Glucose Lowering Effect of Metformin and Sitagliptin in Adolescents With Type 1 Diabetes
Overview[ - collapse ][ - ]
Purpose | The purpose of this study is to see if the use of metformin and sitagliptin used in conjunction with insulin can improve the blood sugars of teenagers with Type 1 diabetes. |
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Condition | Type 1 Diabetes |
Intervention | Drug: Sitagliptin Drug: Metformin Drug: Sitagliptin + Metformin |
Phase | Phase 4 |
Sponsor | Baylor College of Medicine |
Responsible Party | Baylor College of Medicine |
ClinicalTrials.gov Identifier | NCT01718093 |
First Received | October 29, 2012 |
Last Updated | October 29, 2012 |
Last verified | May 2012 |
Tracking Information[ + expand ][ + ]
First Received Date | October 29, 2012 |
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Last Updated Date | October 29, 2012 |
Start Date | October 2012 |
Estimated Primary Completion Date | December 2015 |
Current Primary Outcome Measures | To determine the glucose lowering effect of metformin and sitagliptin alone and as combination therapy when used as adjuncts to insulin in adolescents with T1DM. [Time Frame: 10 - 15 weeks] [Designated as safety issue: No] |
Current Secondary Outcome Measures | Not Provided |
Descriptive Information[ + expand ][ + ]
Brief Title | A Pilot Study to Assess the Glucose Lowering Effect of Metformin and Sitagliptin in Adolescents With Type 1 Diabetes |
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Official Title | A Pilot Study to Assess the Glucose Lowering Effect of Metformin and Sitagliptin in Adolescents With Type 1 Diabetes Mellitus |
Brief Summary | The purpose of this study is to see if the use of metformin and sitagliptin used in conjunction with insulin can improve the blood sugars of teenagers with Type 1 diabetes. |
Detailed Description | - The study will include a total of 4 visits. The time period between the very first visit and the very last visit will be between 10 and 15 weeks. Each participant will be randomized to one of the 3 groups in the study. The groups are as follows: - Group 1: Insulin and sitagliptin - Group 2: Insulin and metformin - Group 3: Insulin and combination of sitagliptin and metformin - The study is a randomized open label design. All subjects will undergo a screening visit; if inclusion and exclusion criteria are fulfilled they will be enrolled in the study. At the time of enrollment the subject will continue their home insulin regimen and will be randomized to an add an oral hypoglycemic agent(s) : metformin, sitagliptin or combination therapy (metformin and sitagliptin). The total duration on study medication will be 6 weeks. All subjects will undergo a baseline mixed meal tolerance test (MMTT) in their standard or usual insulin Each subject will undergo a total of two studies. Blood draws will be necessary. |
Study Type | Interventional |
Study Phase | Phase 4 |
Study Design | Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment |
Condition | Type 1 Diabetes |
Intervention | Drug: Sitagliptin up to 50 mg twice a day Other Names: JanuviaDrug: Metformin up to 1000 mg twice a day Other Names: GlucophageDrug: Sitagliptin + Metformin up to 50/1000 mg twice a day Other Names: Sitagliptin + Metformin = Janumet |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Recruiting |
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Estimated Enrollment | 48 |
Estimated Completion Date | December 2015 |
Estimated Primary Completion Date | December 2015 |
Eligibility Criteria | Inclusion Criteria: - Age of 13 to 18 years - HbA1c >7.5% but <10% - Subjects must be on intensive insulin management - Tanner stage greater than or equal to 4 - Must have T1DM for at least one year , T1DM defined by ADA criteria and having at least one of the following antibodies: Anti-GAD, Anti-islet, Anti-insulin - C-peptide > 0.6 ng/ml Exclusion Criteria: - Type 2 diabetes - History of any other chronic condition (except hypothyroidism stable on medications) - Actively taking medications that may affect glucose excursions (steroids or oral contraceptives) - Evidence of anemia, clinically significant elevation of the liver enzymes (3 X normal), amylase or lipase (2 X normal), abnormal triclycerides (3 X normal), abnormal renal function test - An unsupportive family environment and pregnant or lactating females |
Gender | Both |
Ages | 13 Years |
Accepts Healthy Volunteers | No |
Contacts | Contact: Kathy Shippy, RN, CCRP 832-824-1268 klshippy@texaschildrens.org |
Location Countries | United States |
Administrative Information[ + expand ][ + ]
NCT Number | NCT01718093 |
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Other Study ID Numbers | H-29924 |
Has Data Monitoring Committee | Yes |
Information Provided By | Baylor College of Medicine |
Study Sponsor | Baylor College of Medicine |
Collaborators | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
Investigators | Principal Investigator: Luisa M. Rodriguez, MD, MS Baylor College of Medicine |
Verification Date | May 2012 |
Locations[ + expand ][ + ]
Baylor College of Medicine | Houston, Texas, United States, 77030 Contact: Kathy Shippy, RN, CCRP | 832-824-1268 | klshippy@texaschildrens.orgPrincipal Investigator: Luisa Rodriguez, MD, MS Recruiting |
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