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
Overview
- Phase
- Phase 1
- Intervention
- Exenatide
- Conditions
- Type 1 Diabetes
- Sponsor
- Yale University
- Enrollment
- 17
- Locations
- 1
- Primary Endpoint
- Effect of exenatide on metabolic responses to an oral (as a mixed meal) or intravenous glucose challenge in subjects with established T1D with or without residual insulin production.
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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 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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Single-arm treatment with Exenatide
Exenatide 5 mcg sc. injection 15 minutes prior to a MMTT and IVGTT
Intervention: Exenatide
Outcomes
Primary Outcomes
Effect of exenatide on metabolic responses to an oral (as a mixed meal) or intravenous glucose challenge in subjects with established T1D with or without residual insulin production.
Time Frame: Each patients is estimated to finish the study within 4-6 weeks
We will measure the hormonal and metabolic changes during a mixed meal and intravenous glucose tolerance test with and without exenatide pretreatment in subjects with and without residual insulin production.
Secondary Outcomes
- Effect of exenatide on insulin secretion, glucagon secretion, GLP-1 and GIP levels, and gastric emptying in these patients with T1D. - effect of exenatide on residual insulin production(4-6 weeks)