NCT01269034 trial results
New Onset Type 1 Diabetes: Role of Exenatide
- Participants
- 13
- Status
- completed
- Completed
- 2017-01-31
- Sponsor
- Albert Einstein College of Medicine
As posted on ClinicalTrials.gov (NCT01269034), updated at source Aug 4, 2021. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.
How NCT01269034 was run
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.
- Part A: Exenatide and long acting insulin before the boost.
- Part B: Rapid and long acting insulin before the boost
- Part C: long acting insulin+ rapid acting+1.25 mcg Exenatide before the boost
- Healthy controls: healthy controls without any medication before the boost.
Who could join the trial
Inclusion Criteria: 1. Age between 12-18 years of age at the time of enrollment. 2. Diagnosed with antibody positive T1DM in the past 3 months. 3. Otherwise healthy except for their TIDM and treated hypothyroidism. 4. Females must have a negative pregnancy test. 5. Hemoglobin equal to or greater than 12 g/dl before each study. 6. Weight greater than 44 kg. Exclusion Criteria: 1. Any chronic disease: leukemia, inflammatory bowel disease, cystic fibrosis, juvenile rheumatoid arthritis etc, except for diabetes and hypothyroidism. 2. Any medications that may affect glucose metabolism. 3. Abnormal AST, ALT, amylase, lipase, creatinine (more than 3 times normal values). 4. Lack of a supportive family environment as detected by the clinicians and/or social workers. 5. History of substance abuse (evaluated by medical history and CRAFFT questionnaire which will be administered at the screening visit). 6. Positive pregnancy test in females. 7. Lactating and nursing mothers.
Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.