A Pilot Study to Assess the Glucose Lowering Effect of Metformin and Sitagliptin in Adolescents With Type 1 Diabetes

• Status: Completed
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Baylor College of Medicine
• Collaborator: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Treatments: Metformin; Sitagliptin Phosphate

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