Study of the Acute Metabolic Effect of Exenatide in Type 1 Diabetes



Status:Completed
Conditions:Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - 56
Updated:4/2/2016
Start Date:January 2012
End Date:October 2013
Contact:Tara Ghazi, MD
Email:tara.ghazi@yale.edu
Phone:203-737-2737

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A Pilot Study to Determine the Effects of a Single Dose of Exenatide (Byetta ®) on the Acute Metabolic Responses to a Mixed Meal or Intravenous Glucose Tolerance Test in Patients With Type 1 Diabetes

The study is designed as an open labeled pilot trial to analyze the acute responses of
glucose, GLP-1, GIP, insulin secretory,and glucagon to a mixed meal tolerance test (MMTT) or
intravenous glucose tolerance tests (IVGTT) with and without pretreatment with Exenatide
(Byetta) 5 mcg sc.

The investigators will also test the effects of Exenatide on gastric emptying during the
MMTT.


Inclusion Criteria:

- T1D of at least 3 yrs duration.

- Male or female aged 18-56 years who meets the American Diabetes Association standard
T1DM criteria.

- HgbA1c<9%

- Insulin requirement of < 0.8 U/kg/d

- Absence of severe hypoglycemia in the past 6 months

- Absence of ketoacidosis in the past 6 months

- Menstruating women must have a negative pregnancy test and be willing to avoid
pregnancy during the study period.

- Signed informed consent..

Exclusion Criteria:

- Inability or unwillingness to give informed consent.

- Prior Exenatide or Liraglutide treatment or use of any medication that could
potentially affect diabetes or immunologic status

- Known hypersensitivity to Exenatide or any product components

- Participation in an investigational treatment trial within the last 6 weeks before
enrollment.

- Any medical condition that in the opinion of the investigator would interfere with
safe completion of the trial such as: epilepsy, atopic disease, active Grave's
disease, cystic fibrosis, sickle cell anemia, neuropathy, peripheral vascular
disease, cerebrovascular disease,liver disease, HIV, or any concurrent autoimmune
disease except treated and stable thyroid disease

- Known severe renal impairment, end-stage renal disease or renal transplantation.

- Any history of gastroparesis or other severe gastrointestinal disease, pancreatitis,
thyroid nodules or malignancy with the exclusion of a history of localized basal cell
carcinoma.

- Uncompensated heart failure, fluid overload, myocardial infarction or liver disease
within the last 6 weeks before enrollment.

- Active clinically serious infections.

- Positive pregnancy test in menstruating women or lactating females
We found this trial at
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New Haven, Connecticut 06520
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