The Effect of Byetta and Symlin on Post-meal Meal Blood Sugar Levels in Children With Type 2 Diabetes (T2DM)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00950677|
Recruitment Status : Completed
First Posted : August 3, 2009
Last Update Posted : April 24, 2017
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes||Drug: Byetta (exenatide) Drug: Symlin (pramlintide)||Phase 4|
A large study in people with type 2 diabetes (T2DM) 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 by several hormones. Insulin (the hormone that lowers blood sugar) and glucagon (hormone that raises blood sugar) play a key role in keeping this careful balance. Also, we now know of 2 new substances made by the body called amylin and GLP-1 that also help with this careful balance. Amylin is made in the pancreas. GLP-1 is made in the gut. We know that both amylin and GLP-1 are abnormal in people with diabetes.
There are two medicines that may help to control after meal blood sugars from going too high. The medicines are called Symlin (pramlintide) and Byetta (exenatide). Symlin works like amylin. Byetta works like GLP-1. Both medications are very similar in the ways that they work to control blood sugars.
Both medicines help to keep glucagon lower after a meal. They both also help the stomach to digest food more slowly so the blood sugar does not go up too fast after eating. They also help to control how much hunger a person may have before meals. This may help a person to eat less and possibly lose weight. Byetta also seems to help islet cells (cells that make insulin) make more insulin.
Byetta and Symlin are FDA approved for use in adults with T2DM. We want to study these drugs in children with T2DM.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Official Title:||The Effect of the Glucagon Suppressors Pramlintide and Exenatide on Postprandial Glucose Metabolism in Children With Type 2 Diabetes Mellitus|
|Study Start Date :||July 2009|
|Actual Primary Completion Date :||May 2011|
|Actual Study Completion Date :||May 2011|
Active Comparator: exenatide
exenatide one dose
Drug: Byetta (exenatide)
exenatide 5 mcg subcutaneously
Active Comparator: pramlintide
pramlintide one dose
Drug: Symlin (pramlintide)
pramlintide 60 mcg subcutaneously
- Glucose [ Time Frame: 4 hours ]concentration and AUC calculations
- glucagon [ Time Frame: 4 hrours ]concentration and AUC calculations
- gastric emptying [ Time Frame: 4 hours ]concentration and AUC calculations
- pramlintide concentrations [ Time Frame: 4 hours ]concentration and AUC calculations
- exenatide concentrations [ Time Frame: 4 hours ]concentration and AUC calculations
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00950677
|United States, Texas|
|Baylor College of Medicine|
|Houston, Texas, United States, 77030|
|Principal Investigator:||LUISA M RODRIGUEZ, MD||Baylor College of Medicine|