New Onset Type 1 Diabetes: Role of Exenatide

What this study is testing ClinicalTrials.gov NCT01269034 ↗

Description as written by the study sponsor.

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.

Treatments tested

• Exenatide also known as Byetta Drug

  1.25 mcg before the boost sub-cutaneously.

• Rapid and long acting insulin also known as Novolog/ Humalog, Lantus/ Levemir Drug

  Depends on their Carbohydrate ratio and body needs

• long acting insulin + rapid acting + 1.25 mcg Exenatide also known as Lantus, Levemir Drug

  Depends on their body needs.