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

Type 1 Diabetes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01855490
• Other study ID #: 1201009520
• Status: Completed
• Phase: Phase 1
• First received: January 29, 2013
• Last updated: July 5, 2016
• Start date: January 2012
• Est. completion date: October 2013

Study information

• Verified date: July 2016
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: October 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 56 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Drug:
• Exenatide

Locations

Country	Name	City	State
United States	Yale School of Medicine	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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.	Each patients is estimated to finish the study within 4-6 weeks	No
Secondary	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	In addition to measuring the levels of glucose and gastric emptying, we will measured glucagon levels, insulin secretion rates, GLP-1 and GIP hormonal levels during the provocative tests.	4-6 weeks	Yes