Type 1 Diabetes: Age 18 to 65 Years – Two Years or More After Diabetes Diagnosis (Bydureon)

 

 

Study Name: Phase II Trial to Examine the Effects of Subcutaneous Exenatide (Bydureon) on Glucose Control in Patients with Type 1 Diabetes

Study Sponsors: Juvenile Diabetes Research Foundation International (JDRF) and Bristol-Myers Squibb

Principal Investigator: Stephen E. Gitelman, MD

Who can sign up for this study? Volunteers must be 18-65 years old and have had diabetes for two years or more.

In addition, volunteers cannot have any of the following conditions:

  • No heart disease
  • No kidney problems
  • No pancreatitis
  • No pregnancy or breastfeeding

What is this study about? The UCSF Diabetes Program is conducting a study to evaluate the use of Bydureon in adults with type 1 diabetes (T1DM). The purpose is to see if Bydureon in combination with intensive insulin therapy in individuals with T1DM can improve glycemic control and lower HbA1cs.

What will happen in this study? All volunteers will undergo a screening visit where they will be asked questions about their medical history, undergo a physical exam, and provide blood and urine for tests. Volunteers who qualify and are enrolled will receive a six-month course of Bydureon or matching placebo injection. You cannot choose which group you will be in. You will be randomly chosen to be in a group. Neither you nor the study team will know which group you are in.

All volunteers will be monitored for one year to assess their overall health and to perform laboratory testing to determine the effects of the treatment. This will require several visits to UCSF for laboratory testing during this period. There will be follow-up visits at 1, 3, 6, 9, and 12 months. Blood will be drawn at each visit for lab work.

How long will this study last? Each volunteer will be followed for approximately 12 months.

Reimbursement: You will not be charged for any of the study treatments and may be eligible for reimbursement for your time and effort.

For more information: Please contact clinicalresearch@diabetes.ucsf.edu or call 844-T1D-UCSF (844-814-8273).