Clinical trial NCT01855490: Study of the Acute Metabolic Effect of Exenatide in Type 1 Diabetes
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 1 Diabetes
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2013-05-16
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 56
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: 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.
timeFrame: Each patients is estimated to finish the study within 4-6 weeks
Secondary outcomes:
measure: 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
timeFrame: 4-6 weeks
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale School of Medicine
state: Connecticut
Study officials:
affiliation: Yale University
name: Kevan C Herold, MD
role: PRINCIPAL_INVESTIGATOR
References: