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Completed

NCT Number: NCT01855490

Study of the Acute Metabolic Effect of Exenatide in 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.

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Key information

Age range

18 year–56 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Yale School of Medicine

New Haven, Connecticut, 06519, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

exenatide

Drug

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.

    Time frame: 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 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
May 16, 2013
Registry last updated
Jul 7, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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