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CompletedNCT01855490Updated Jul 7, 2016

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

A Phase 1 interventional study of Exenatide in Type 1 Diabetes, sponsored by Yale University. Completed at 1 site in United States. Open to participants aged 18 Years to 56 Years. Per ClinicalTrials.gov, last updated 2016-07-07.

Sponsored by Yale University · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
17
Allocation
Not applicable
Ages
18 Years to 56 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Type 1 Diabetes
03

In context

Diabetes Mellitus, Type 1

3,614 studies on the registry are indexed under Diabetes Mellitus, Type 1; 586 are open to participants now.

This study's enrollment of 17 is below the median of 40 across 2,718 interventional studies indexed under Diabetes Mellitus, Type 1.

Browse Diabetes Mellitus, Type 1 studies →

Lead sponsor

Yale University is the lead sponsor of 1,763 studies on the registry; 292 are open to participants now.

Of its 217 completed or terminated interventional studies of FDA-regulated products, 128 (59%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 56 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
17 participants (actual)

Study arms

  • Experimental
    Single-arm treatment with Exenatide

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

    Drug: Exenatide

Interventions

06

What researchers measure

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.

    Time frame: 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

    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.

    Time frame: 4-6 weeks

07

Study locations

1 site
  • Yale School of Medicine
    New Haven, Connecticut 06519, United States
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jan 2012, a primary completion of Jul 2013 and a completion of Oct 2013. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 29, 2013
First posted
May 16, 2013
Start
Jan 2012
Primary completionActual
Jul 2013
CompletionActual
Oct 2013
Last update
Jul 7, 2016
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 7, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01855490
Lead sponsor
Yale University
Responsible party
Sponsor
First posted
May 16, 2013
Start date
Jan 2012
Primary completion
Jul 2013
Completion
Oct 2013
Last update
Jul 7, 2016

Study contacts

Kevan C Herold, MD
principal investigator · Yale University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.

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Discussion

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