Ignite Creation Date:
2024-05-05 @ 5:26 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00457093
Status:
COMPLETED
Last Update Posted:
2010-11-18
First Post:
2007-04-03
Brief Title:
A Comparison Between Glargine and Detemir Insulin in Type 2 Diabetes
Sponsor:
Diabetes Care Center
Organization:
Diabetes Care Center
Study Overview
Official Title:
A Double Blind Randomized Parallel Cross-Over Comparision of Glycemic Control Achieved With Once a Day Insulin Glargine Versus Detemir in Type 2 Diabetes
Status:
COMPLETED
Status Verified Date:
2007-04
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 that when studies using our method of dosing adjustments driven by continuous glucose monitoring and because of the less variable glycemic effect of insulin detemir insulin detemir treated subjects will spend a significantly greater time in the glucose target range than insulin glargine
Detailed Description:
Todate most studies have compared insulin detemir and glargine to NPH and not to each other Depending of their design these studies have shown both insulins lower the fasting glucose A1c the incidence of hypoglycemia and are associated with less weight gain than NPH In the only direct comparison study of these two basal insulins insulin detemir demonstrated significantly less day to day variation than glargine as measured by glucose infusion rated during an euglycemic clamp study Given the same incidence of hypoglycemia this last study would suggest that insulin detemir treatment could achieve target glucose control more than glargine We have used continuous glucose monitoring CGMS extensively in our practice CGMS is arguably the most sensitive method for detecting differences in glycemic control in the outpatient setting and there by allowing fine adjustments in insulin treatment When comparing insulin glargine to preprogrammable basal insulin as delivered by continuous subcutaneous infusion and using CGMS we have shown significantly better glucose control with continuous subcutaneous infusion We have also developed a method of daily insulin dosage adjustments during a continuous CGMS study from daily glucose tracings downloaded This allows for an even more accurate basal insulin replacement per set glycemic goal This protocol addresses a comparison of insulin glargine and insulin detemir for patients evaluated by CGMS
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