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 |
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.
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
1
site
Click here to add this to my saved trials