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
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- 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.
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 56 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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 (Drug)
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)