Phase 4
N=13
New Onset Type 1 Diabetes: Role of Exenatide
Type 1 Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT01269034 ↗Enrolled (actual)
13
Serious AEs
0.0%
Results posted
Aug 2021
Primary outcome: Primary: The Role of Exenatide as Compared to Insulin Monotherapy in Reducing Postprandial Hyperglycemia.
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Exenatide (Drug); Rapid and long acting insulin (Drug); long acting insulin + rapid acting + 1.25 mcg Exenatide (Drug)
- Age
- Pediatric, Adult · 12+ yrs
- Sex
- All
- Sponsor
- Albert Einstein College of Medicine
- Primary completion
- Jan 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Role of Exenatide as Compared to Insulin Monotherapy in Reducing Postprandial Hyperglycemia. |
— | — |
| SECONDARY The Role of Exenatide on Postprandial Glucagon and Gastric Emptying. |
— | — |
| SECONDARY Postprandial Glucose Excursions, Glucagon Concentrations and Gastric Emptying in Normal Healthy Controls. |
— | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT01269034). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.