New Onset Type 1 Diabetes: Role of Exenatide
Primary Purpose
Type 1 Diabetes
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Exenatide
Rapid and long acting insulin
long acting insulin + rapid acting + 1.25 mcg Exenatide
Sponsored by
About this trial
This is an interventional treatment trial for Type 1 Diabetes focused on measuring Type 1 diabetes Milletus, diabetes, healthy controls, exenatide, byetta
Eligibility Criteria
Inclusion Criteria:
- Age between 12-18 years of age at the time of enrollment.
- Diagnosed with antibody positive T1DM in the past 3 months.
- Otherwise healthy except for their TIDM and treated hypothyroidism.
- Females must have a negative pregnancy test.
- Hemoglobin equal to or greater than 12 g/dl before each study.
- Weight greater than 44 kg.
Exclusion Criteria:
- Any chronic disease: leukemia, inflammatory bowel disease, cystic fibrosis, juvenile rheumatoid arthritis etc, except for diabetes and hypothyroidism.
- Any medications that may affect glucose metabolism.
- Abnormal AST, ALT, amylase, lipase, creatinine (more than 3 times normal values).
- Lack of a supportive family environment as detected by the clinicians and/or social workers.
- History of substance abuse (evaluated by medical history and CRAFFT questionnaire which will be administered at the screening visit).
- Positive pregnancy test in females.
- Lactating and nursing mothers.
Sites / Locations
- Albert Einstein CRC- West Campus
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Active Comparator
Active Comparator
No Intervention
Arm Label
Part A
Part B
Part C
Healthy controls
Arm Description
Exenatide and long acting insulin before the boost.
Rapid and long acting insulin before the boost
long acting insulin+ rapid acting+1.25 mcg Exenatide before the boost
healthy controls without any medication before the boost.
Outcomes
Primary Outcome Measures
The Role of Exenatide as Compared to Insulin Monotherapy in Reducing Postprandial Hyperglycemia.
Data for this outcome measure are no longer accessible; the PI has left institution and all efforts to locate the data have been exhausted.
Secondary Outcome Measures
The Role of Exenatide on Postprandial Glucagon and Gastric Emptying.
Data for this outcome measure are no longer accessible; the PI has left institution and all efforts to locate the data have been exhausted.
Postprandial Glucose Excursions, Glucagon Concentrations and Gastric Emptying in Normal Healthy Controls.
Data for this outcome measure are no longer accessible; the PI has left institution and all efforts to locate the data have been exhausted.
Full Information
NCT ID
NCT01269034
First Posted
December 29, 2010
Last Updated
July 13, 2021
Sponsor
Albert Einstein College of Medicine
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1. Study Identification
Unique Protocol Identification Number
NCT01269034
Brief Title
New Onset Type 1 Diabetes: Role of Exenatide
Official Title
New Onset Type 1 Diabetes: Role of Exenatide
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
January 31, 2017 (Actual)
Study Completion Date
January 31, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Albert Einstein College of Medicine
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
There are many recent advances in insulin treatment of type 1 diabetes, however after a meal sugars are always a concern. There is a drug Exenatide (Byetta) which is FDA approved to treat people with type 2 diabetes which helps correct their glucoses (sugars) after meals. This study is going to test whether this drug can improve the after meal sugars in people with new onset type 1 diabetes. To test this you will be given a dose of exenatide (1.25 mcg) and long acting insulin or inulin alone before the boost. There is also a placebo group (healthy subjects) who do not get any medication before the boost. Insulin levels and other hormones that affect blood glucose as well as your sugar will be measured by a series of blood tests. The role exenatide as compared to insulin alone will be examined to prevent low blood sugars which might occur because of food staying longer in the stomach than usual or due to the suppression of a hormone called glucagon which increases blood sugar. If you qualify you will be given exenatide (Byetta 1.25 mcg) along with insulin or insulin alone. You and the researchers will not know which dose you are taking at any single visit. A total of 20 people in which some will be children aged 12- 18 years will participate, being diagnosed within 3 months of having been found to have type 1 diabetes.
Detailed Description
The specific aims of this study are to determine the following:
The role of exenatide as compared to insulin monotherapy in reducing postprandial hyperglycemia.
The role of exenatide on postprandial glucagon and gastric emptying.
The effect of long acting insulin on postprandial glucose excursions, glucagon concentrations and gastric emptying.
Postprandial glucose excursions, glucagon concentrations and gastric emptying in normal healthy controls.
Study Design:
A randomized, non-blinded trial with a crossover design will be used. Following informed consent and with appropriate subject assent, all subjects will have a screening visit. Following the screening visit, subjects with T1DM will undergo 3 studies: Part A (exenatide and long acting insulin), Part B (rapid and long acting insulin) and Part C (long acting insulin only). The subjects will be admitted to the CRC on three separate occasions, at least 3-4 weeks apart. The three studies will be performed in a random order and the randomization will be done using a computerized system. The healthy controls will undergo a single study visit. Except for the absence of diabetes, the healthy controls will be identical to the study subjects. Subjects with new onset diabetes will be compared to healthy controls.
During the study, if blood glucose values in a subject are less than 55 mg/dl, IV glucose of 5-15 grams will be administered to achieve euglycemia (90-130 mg/dl). 1-2 doses of IV glucose should correct hypoglycemia. If more than 3 doses are required to achieve euglycemia, the study will be terminated, the subject will be offered a meal tray and blood sugar rechecked to ensure euglycemia. If blood sugar at any time is more than 350 with moderate ketones, the study will be terminated.
At around 1 PM (270 min), lunch will be provided (consistent carbohydrate meal) and insulin will be given as per the subject's prescribed regimen. The subject will be discharged home with a designated driver due to the risk of hypoglycemia.
A subject will be withdrawn from participating in the study if he/she meets any of the following conditions: 1)develops a chronic disease 2)develops anemia 3)becomes pregnant 4)develops a weight loss of greater than 10 pounds for unspecified reasons 5)loss of contact- if the investigators are unable to reach a study subject (within 2 months of screening or completion of the first study) by phone or mail to schedule the next appointment. All study subjects (that are withdrawn from the study) will receive a phone call and a letter notifying them that they have been withdrawn.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
Keywords
Type 1 diabetes Milletus, diabetes, healthy controls, exenatide, byetta
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Part A
Arm Type
Experimental
Arm Description
Exenatide and long acting insulin before the boost.
Arm Title
Part B
Arm Type
Active Comparator
Arm Description
Rapid and long acting insulin before the boost
Arm Title
Part C
Arm Type
Active Comparator
Arm Description
long acting insulin+ rapid acting+1.25 mcg Exenatide before the boost
Arm Title
Healthy controls
Arm Type
No Intervention
Arm Description
healthy controls without any medication before the boost.
Intervention Type
Drug
Intervention Name(s)
Exenatide
Other Intervention Name(s)
Byetta
Intervention Description
1.25 mcg before the boost sub-cutaneously.
Intervention Type
Drug
Intervention Name(s)
Rapid and long acting insulin
Other Intervention Name(s)
Novolog/ Humalog, Lantus/ Levemir
Intervention Description
Depends on their Carbohydrate ratio and body needs
Intervention Type
Drug
Intervention Name(s)
long acting insulin + rapid acting + 1.25 mcg Exenatide
Other Intervention Name(s)
Lantus, Levemir
Intervention Description
Depends on their body needs.
Primary Outcome Measure Information:
Title
The Role of Exenatide as Compared to Insulin Monotherapy in Reducing Postprandial Hyperglycemia.
Description
Data for this outcome measure are no longer accessible; the PI has left institution and all efforts to locate the data have been exhausted.
Time Frame
February 2013
Secondary Outcome Measure Information:
Title
The Role of Exenatide on Postprandial Glucagon and Gastric Emptying.
Description
Data for this outcome measure are no longer accessible; the PI has left institution and all efforts to locate the data have been exhausted.
Time Frame
February 2013
Title
Postprandial Glucose Excursions, Glucagon Concentrations and Gastric Emptying in Normal Healthy Controls.
Description
Data for this outcome measure are no longer accessible; the PI has left institution and all efforts to locate the data have been exhausted.
Time Frame
February 2013
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age between 12-18 years of age at the time of enrollment.
Diagnosed with antibody positive T1DM in the past 3 months.
Otherwise healthy except for their TIDM and treated hypothyroidism.
Females must have a negative pregnancy test.
Hemoglobin equal to or greater than 12 g/dl before each study.
Weight greater than 44 kg.
Exclusion Criteria:
Any chronic disease: leukemia, inflammatory bowel disease, cystic fibrosis, juvenile rheumatoid arthritis etc, except for diabetes and hypothyroidism.
Any medications that may affect glucose metabolism.
Abnormal AST, ALT, amylase, lipase, creatinine (more than 3 times normal values).
Lack of a supportive family environment as detected by the clinicians and/or social workers.
History of substance abuse (evaluated by medical history and CRAFFT questionnaire which will be administered at the screening visit).
Positive pregnancy test in females.
Lactating and nursing mothers.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ranjitha Katikaneni, MB; BS
Organizational Affiliation
Montefiore Children's hospital
Official's Role
Study Director
Facility Information:
Facility Name
Albert Einstein CRC- West Campus
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
12. IPD Sharing Statement
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New Onset Type 1 Diabetes: Role of Exenatide
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