A Phase II Trial to Examine the Effect of Subcutaneous Exenatide (Bydureon®) on Glucose Control in Patients with Type I Diabetes

Conditions

Type 1 Diabetes

What is the purpose of this trial?

The purpose of this study is to investigate the effect of once weekly exenatide (Bydureon), a GLP-1 analog in type 1 diabetes. Exenatide has been on the market for some time for treatment of type 2 diabetes and has shown to be an ;effective treatment alternative in this group of patients.

We want to investigate the effects of Bydureon in type 1 diabetes by conducting a large (120 participants) multi-center(several sites around the US) placebo controlled study. The goal of the study is to determine whether glucose control can be improved with Bydureon treatment in patients with type 1 diabetes (T1D).

The study length is 1 year, which includes 6 months of treatment with either the active drug or placebo and 6 months of follow up. There will be 7 visits altogether during the study, 5 of which consist of a 4 hour or 2 hour mixed meal tolerance test.

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Participation Guidelines

Age:
18 Years - 60 Years
Gender:
Both

Click here for detailed information about who can participate in this trial.


Sponsor:
Juvenile Diabetes Research Foundation International
Dates:
10/08/2013
Last Updated:
Study HIC#:
1307012371