Ignite Creation Date:
2024-05-05 @ 5:25 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00451620
Status:
COMPLETED
Last Update Posted:
2018-01-18
First Post:
2007-03-21
Brief Title:
Effect of GlucoNorm vs Glyburide on Post-Prandial Hyperglycemia in Elderly Subjects With Type 2 Diabetes
Sponsor:
University of British Columbia
Organization:
University of British Columbia
Study Overview
Official Title:
Effect of GlucoNorm vs Glyburide on Post-Prandial Hyperglycemia in Elderly Subjects With Type 2 Diabetes
Status:
COMPLETED
Status Verified Date:
2018-01
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 results from the DECODE Study have shown that postprandial 1 - 2 hours after a meal hyperglycemia elevated blood sugar is more common in elderly people with diabetes than younger people with diabetes and is the best predictor of the development of complications The DECODE Study involved 6941 people who already had diabetes and 702 who did not have diabetes Diabetes is diagnosed when the blood sugar 1st thing in the morning is over 70 mmolL The DECODE Study showed that people at risk for diabetes can have a normal blood sugar 1st thing in the morning but have a high blood sugar 2 hours after a meal and that these people are at risk for developing heart disease and other complications of diabetes These people would not be identified as at risk if only a fasting blood sugar is done Studies in younger people with diabetes have shown that after a meal insulin levels are more like a person without diabetes and glucose blood sugar levels are lower with GlucoNorm than with Glyburide There is no data available that demonstrates this in elderly people with type 2 diabetes
You have been invited to participate in this study because you have type 2 diabetes controlled by diet andor exercise or metformin only and are over 65 years of age
The purpose of this study is to determine whether GlucoNorm has a greater effect than Glyburide on insulin levels and glucose blood sugar levels after a meal in elderly people with type 2 diabetes who control their diabetes with diet and exercise
You have been invited to participate in this study because you have type 2 diabetes controlled by diet andor exercise or metformin only and are over 65 years of age
The purpose of this study is to determine whether GlucoNorm has a greater effect than Glyburide on insulin levels and glucose blood sugar levels after a meal in elderly people with type 2 diabetes who control their diabetes with diet and exercise
Detailed Description:
The results from the DECODE Study have shown that postprandial hyperglycemia is more common in elderly people with diabetes than younger people and is the best predictor of mortality and morbidity Studies in younger people with diabetes have shown that in response to a meal insulin profiles are more physiologic and glucose levels are lower with GlucoNorm than with Glyburide There is no data available that demonstrates this in elderly people with type 2 diabetes
This is a randomized open-label cross-over study Subjects will undergo 2 Standard Meal Tests with Ensure 325 ml separated by 15 - 30 days Group 1 will receive GlucoNorm 1 mg during the 1st Standard Meal Test and Glyburide 25 mg during the 2nd Standard Meal Test Group 2 will receive Glyburide 25 mg during the 1st Standard Meal Test and GlucoNorm 1mg during the 2nd Standard Meal Test
This is a randomized open-label cross-over study Subjects will undergo 2 Standard Meal Tests with Ensure 325 ml separated by 15 - 30 days Group 1 will receive GlucoNorm 1 mg during the 1st Standard Meal Test and Glyburide 25 mg during the 2nd Standard Meal Test Group 2 will receive Glyburide 25 mg during the 1st Standard Meal Test and GlucoNorm 1mg during the 2nd Standard Meal Test
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| H02-70584 | None | None | None |