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

NCT01855490 | Completed Phase 1

• 1 other identifier: 1201009520
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (1)

Single-arm treatment with Exenatide

EXPERIMENTAL

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

Drug: Exenatide

Interventions

Exenatide DRUG

Single-arm treatment with Exenatide

Eligibility Criteria

• Age: 18 Years - 56 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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..

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Yale School of Medicine

New Haven, Connecticut, 06519, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Exenatide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Peptides; Amino Acids, Peptides, and Proteins; Venoms; Complex Mixtures; Toxins, Biological; Biological Factors

Study Officials

• Kevan C Herold, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2013
• First Posted: May 16, 2013
• Study Start: January 1, 2012
• Primary Completion: July 1, 2013
• Study Completion: October 1, 2013
• Last Updated: July 7, 2016

Record last verified: 2016-07

Locations

US (1)