A Pilot Study to Assess the Glucose Lowering Effect of Metformin and Sitagliptin in Adolescents With Type 1 Diabetes
Type 1 Diabetes
About this trial
This is an interventional treatment trial for Type 1 Diabetes focused on measuring Adolescents
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
Sites / Locations
- Baylor College of Medicine
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Active Comparator
Active Comparator
Insulin plus sitagliptin
Insulin plus metformin
Insulin plus sitagliptin and metformin
The subjects continued their usual insulin regimen throughout the study. Sitagliptin was started and continued at 50 mg orally twice daily
The subjects continued their usual insulin regimen throughout the study. Metformin was started at 500 mg orally daily. The dose was increased over a 2 week period up to 2,000 mg per day as tolerated.
The subjects continued their usual insulin regimen throughout the study. Sitagliptin was started and continued at 50 mg orally twice daily. Metformin was started at 500 mg orally daily. The dose was increased over a 2 week period up to 2,000 mg per day as tolerated.