Status:
COMPLETED
Study of the Acute Metabolic Effect of Exenatide in Type 1 Diabetes
Lead Sponsor:
Yale University
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
18-56 years
Phase:
PHASE1
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2013
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT01855490
Start Date
January 1 2012
End Date
October 1 2013
Last Update
July 7 2016
Active Locations (1)
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1
Yale School of Medicine
New Haven, Connecticut, United States, 06519