NCT00456300

Role of Exenatide in Type 1 Diabetes

The Role of Exenatide in Type 1 Diabetes Mellitus

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Montefiore Medical Center · Academic / Other
• Sex: All
• Age: 12 Years – 21 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to see if giving exenatide and insulin before a meal would lower blood sugars after the meal. This study may help in developing new treatments to help control high blood sugars after meals. This may help improve overall blood sugar control and prevent the long-term effects of diabetes.

Detailed description

A large study in people with type 1 diabetes (T1DM) showed that lowering blood sugars stopped or delayed the occurrence of health problems. As a result of the study, treatment should try to control blood sugars as near to normal as safely possible. In people without diabetes, the "after meal" blood sugar level is very carefully controlled. Insulin (the hormone that lowers blood sugar) and glucagon (hormone that raises blood sugar) play a key role in keeping this careful balance. It is now known that a substance made by the body called GLP-1 also helps with this careful balance. Glucagon like peptide-1 works in four ways. First, it helps to stimulate the cells in the pancreas to produce more insulin. Secondly, it helps to "dampen" the glucagon response (glucagon is released after a meal and causes the blood sugar to rise). Thirdly, Glucagon like peptide-1 delays the digestion of food in the stomach. Lastly, it seems to "dampen" the appetite, which causes a person to eat less. Exenatide is a medication that works very similar to Glucagon like peptide-1. Exenatide is FDA approved for use in adults. Study Design: Followed by a baseline study with insulin alone, subjects were randomized to two different doses of exenatide (1.25 and 2.5 µ,g), administered in a double-blinded randomized controlled manner, along with insulin as a single subcutaneous injection. Studies were at least 3 weeks apart. Baseline: At 0800 h, the pre-breakfast insulin bolus was administered based on patient's usual insulin-to-carbohydrate ratio. Post-bolus, subjects drank 12 ounces of a standard liquid meal (Boost High Protein Drink, 360 calories, 50 g carbohydrates, and 12 g fat), enriched with 1 g of \[13C\] glucose within 10 min. Breath samples for 13CO2 analysis were collected in duplicates at 17 time points until 1300 h. Usual insulin basal rates or glargine were maintained during study. On the days subjects received the study drug of 1.25 µ,g (\~0.02 µ,g/kg) or 2.5 µ,g (\~0.04 µ,g/kg) exenatide along with insulin, the prandial insulin was reduced by 20%. Measurements: Plasma glucose was measured using a bedside YSI glucose analyzer (2300 Stat Plus; Yellow Springs Instruments, Yellow Springs, OH) throughout the study at regularly timed intervals. Delta plasma glucose area under the curve (AUC0 -120) was measured for the exenatide treated groups vs. insulin monotherapy.

Conditions

• Type 1 Diabetes

Interventions

Type	Name	Description
DRUG	Exenatide	In each intervention arm the participant receives a different dose (1.25 or 2.5 mcg) of exenatide.
DRUG	Insulin	Each subject received a baseline study with insulin alone

Timeline

• Start date: 2007-03-01
• Primary completion: 2009-03-01
• Completion: 2009-03-01
• First posted: 2007-04-04
• Last updated: 2019-02-26
• Results posted: 2019-02-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study