Role of Exenatide in Type 1 Diabetes
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 problems of diabetes.
|Study Design:||Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||The Role of Exenatide in Type 1 Mellitus|
- Area under the curve for glucose [ Time Frame: 5 hours ] [ Designated as safety issue: Yes ]
|Study Start Date:||March 2007|
|Study Completion Date:||March 2009|
|Primary Completion Date:||March 2009 (Final data collection date for primary outcome measure)|
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 sugar 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. We now know that a substance made by the body called GLP-1 also helps with this careful balance. GLP-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, GLP-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 GLP-1. Exenatide is FDA approved for use in adults.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00456300
|United States, Texas|
|Texas Children's Hospital/ Baylor College of Medicine|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Rubina Heptulla, MD||Baylor College of Medicine|