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

Completed · Phase 4

Conditions studied: Type 1 Diabetes

In brief

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.

Key facts

Study ID

NCT01718093

Run by

Baylor College of Medicine

People needed

21

Starts

2012-10-01

Expected to finish

2015-12-01

Last updated by the study team

2017-04-24

Who can join

Age: 13 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Baylor College of Medicine — Houston, Texas, United States

Full record on ClinicalTrials.gov

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