Study of the Acute Metabolic Effect of Exenatide in Type 1 Diabetes
Completed · Phase 1
Conditions studied: Type 1 Diabetes
In brief
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.
Key facts
- Study ID
- NCT01855490
- Run by
- Yale University
- People needed
- 17
- Starts
- 2012-01-01
- Expected to finish
- 2013-10-01
- Last updated by the study team
- 2016-07-07
Who can join
Age: 18 and older, up to 56. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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..
You may not qualify if…
- 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
Where it is running
- Yale School of Medicine — New Haven, Connecticut, United States
Full record on ClinicalTrials.gov
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