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

Phase 1

Completed

• Conditions: Type 1 Diabetes
• Interventions: Drug: Exenatide

• Registration Number: NCT01855490
• Lead Sponsor: Yale University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2013-01-29
• Study First Submitted QC: 2013-05-15
• Study First Posted: 2013-05-16
• Primary Completion: 2013-07
• Study Completion: 2013-10
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-05
• Last Update Posted: 2016-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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..

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single-arm treatment with Exenatide	Exenatide	Exenatide 5 mcg sc. injection 15 minutes prior to a MMTT and IVGTT

Primary Outcome Measures

Name	Time	Method
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.	Each patients is estimated to finish the study within 4-6 weeks	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.

Secondary Outcome Measures

Name	Time	Method
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	4-6 weeks	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.

Trial Locations

Locations (1)

Yale School of Medicine; 🇺🇸 New Haven, Connecticut, United States