Study of the Acute Metabolic Effect of Exenatide in Type 1 Diabetes

Yale University

Status and phase

Completed

Phase 1

Conditions

Type 1 Diabetes

Treatments

Drug: Exenatide

Study type

Interventional

Funder types

Other

Identifiers

NCT01855490

1201009520

Details and patient eligibility

About

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.

Enrollment

17 patients

Sex

All

Ages

18 to 56 years old

Volunteers

No Healthy Volunteers

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