Ignite Creation Date:
2024-05-05 @ 5:25 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00456300
Status:
COMPLETED
Last Update Posted:
2019-02-26
First Post:
2007-04-03
Brief Title:
Role of Exenatide in Type 1 Diabetes
Sponsor:
Montefiore Medical Center
Organization:
Montefiore Medical Center
Study Overview
Official Title:
The Role of Exenatide in Type 1 Diabetes Mellitus
Status:
COMPLETED
Status Verified Date:
2019-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 125 and 25 µg 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 patients 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 125 µg 002 µgkg or 25 µg 004 µgkg 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
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 125 and 25 µg 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 patients 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 125 µg 002 µgkg or 25 µg 004 µgkg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None