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

NCT ID: NCT01855490

Last Updated: 2016-07-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2013-10-31

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.

Conditions

Type 1 Diabetes

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Single-arm treatment with Exenatide

Exenatide 5 mcg sc. injection 15 minutes prior to a MMTT and IVGTT

Group Type: EXPERIMENTAL

Exenatide

Intervention Type: DRUG

Interventions

Exenatide

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 56 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kevan C Herold, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Yale School of Medicine

New Haven, Connecticut, United States

Countries

United States

Other Identifiers

1201009520

Identifier Type: -

Identifier Source: org_study_id