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

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

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 Overview

• Status: Completed
• Conditions: Type 1 Diabetes
• Intervention / Treatment: Drug: Exenatide

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06519
      • Yale School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 56 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single-arm treatment with Exenatide; Exenatide 5 mcg sc. injection 15 minutes prior to a MMTT and IVGTT	Drug: Exenatide

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Yale University
• Investigators: Principal Investigator: Kevan C Herold, MD, Yale School of Medicine

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): July 1, 2013
• Study Completion (Actual): October 1, 2013

Study Registration Dates

• First Submitted: January 29, 2013
• First Submitted That Met QC Criteria: May 15, 2013
• First Posted (Estimate): May 16, 2013

Study Record Updates

• Last Update Posted (Estimate): July 7, 2016
• Last Update Submitted That Met QC Criteria: July 5, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypoglycemic Agents; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Anti-Obesity Agents; Incretins; Exenatide
• Other Study ID Numbers: 1201009520