CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 13 enrolled
Drug / intervention
Exenatide +2 moredrug
Likely dose
long acting insulin + rapid acting + 1.25 mcg Exenatidefrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01269034
NCT01269034Phase 4Completed

New Onset Type 1 Diabetes: Role of Exenatide

Albert Einstein College of Medicine·interventional·Posted Jan 4, 2011·Updated Aug 4, 2021

In Brief

A Phase 4 clinical trial evaluating Exenatide, Rapid and long acting insulin, and 1 other intervention for Type 1 Diabetes. Completed, enrolled 13 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 1 Diabetes
CountriesUnited States

Timeline

Phase 4CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJan 4, 2011
Enrollment StartDec 1, 2010
Primary CompletionJan 31, 2017
TodayJul 2, 2026
Enrollment to primary: 6.2 yearsPosted 15.5 years ago

Interventions

Exenatidedrug

1.25 mcg before the boost sub-cutaneously.

Rapid and long acting insulindrug

Depends on their Carbohydrate ratio and body needs

long acting insulin + rapid acting + 1.25 mcg Exenatidedrug

Depends on their body needs.