Study of the Acute Metabolic Effect of Exenatide in Type 1 Diabetes
Primary Purpose
Type 1 Diabetes
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Exenatide
Sponsored by
About this trial
This is an interventional treatment trial for Type 1 Diabetes
Eligibility Criteria
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
Sites / Locations
- Yale School of Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Single-arm treatment with Exenatide
Arm Description
Exenatide 5 mcg sc. injection 15 minutes prior to a MMTT and IVGTT
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01855490
Brief Title
Study of the Acute Metabolic Effect of Exenatide in Type 1 Diabetes
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
October 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single-arm treatment with Exenatide
Arm Type
Experimental
Arm Description
Exenatide 5 mcg sc. injection 15 minutes prior to a MMTT and IVGTT
Intervention Type
Drug
Intervention Name(s)
Exenatide
Primary Outcome Measure Information:
Title
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.
Description
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 Outcome Measure Information:
Title
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
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
56 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevan C Herold, MD
Organizational Affiliation
Yale School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study of the Acute Metabolic Effect of Exenatide in Type 1 Diabetes
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