The UF Diabetes Institute is conducting a pilot study to investigate if the drug metformin, an oral medication, helps improve blood sugar control in adolescents who have clinically-diagnosed type 1 diabetes and are overweight. Funded by the Juvenile Diabetes Research Foundation and the Leona M. and Harry B. Helmsley Charitable Trust, the DCE is coordinating with the Jaeb Center for Health Research in Tampa, FL for this study, and are the only two study sites in the state of Florida participating in this research investigation. The study is taking place at 30 study sites across the United States.
“The goal of this study is to see if metformin can improve blood glucose control when used in addition to insulin,” says Michael Haller, MD, pediatric endocrinologist and Principal Research Investigator at the DCE. “Metformin has been well studied in type 2 diabetes, but there are not a lot of studies that have evaluated it’s effectiveness in children with type 1 diabetes.”
The six-month ‘Metformin Therapy for Overweight Adolescents with Type 1 Diabetes’ study will include about 150 people. It’s goal is to learn if metformin will improve blood sugar in adolescents ages 12 to 19 with type 1 diabetes and who have a BMI that is greater or equal to the 85th percentile for height and weight. In some individuals with type 1 diabetes, good blood sugar control is not achieved despite using high doses of insulin. This is particularly true when the individual is overweight.
Based on observations of metformin use in adults and children greater than 10 years of age with type 2 diabetes, researchers speculate that metformin may be a key in better understanding how to control T1D.
According to the American Diabetes Association, nearly 26 million Americans have diabetes, and about ten-percent of this population has type 1 diabetes. “With this study, we want to find out if metformin can improve blood glucose control, reduce weight gain, and potential improve insulin production in children with type 1 diabetes,” says Haller.
Researchers at the DCE are currently recruiting volunteers to take part in this study. In addition to a glucose meter and some test strips, half of the participants will receive metformin. The other half will receive a placebo – a pill that has no drug effect. Participants will have a total of 6 scheduled office visits (including screening visit) and 5 scheduled telephone calls. Individuals will receive regular health care through their own health care providers.
The study will be double-blinded, so neither participants nor the study’s clinical staff will know who is receiving metformin and who is receiving placebo. The study will continue until enough participants have enrolled and have completed all scheduled appointments.
The study will build on some previous smaller studies which have shown benefits of metformin in individuals with type 1 diabetes who are overweight or use large doses of insulin. However, additional safe and effective preventative strategies are needed to help prevent, reverse, and delay the development of type 1 diabetes.
Learn more about the study by calling (352) 273-5580 or visit us at diabetes.ufl.edu/research for more information.
