Ignite Creation Date:
2024-05-05 @ 4:40 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00290979
Status:
COMPLETED
Last Update Posted:
2009-08-26
First Post:
2006-02-10
Brief Title:
Efficacy and Safety of Insulin Glulisine in Type 1 Diabetes Mellitus
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
Evaluation of Efficacy and Safety of HMR1964 Insulin Glulisine in Subjects With Type 1 Diabetes Mellitus Insulin Lispro Controlled Open Randomized Parallel Group Non-inferiority Study for 28 Weeks
Status:
COMPLETED
Status Verified Date:
2009-03
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:
To evaluate non-inferiority in the efficacy of HMR1964 as compared with Insulin lispro in terms of the change in HbA1C from baseline to endpoint
To compare the safety of HMR1964 with insulin lispro
To compare the safety of HMR1964 with insulin lispro
Detailed Description:
To compare HMR1964 with insulin lispro in terms of the change in HbA1C from baseline to week 12 and week 28 consecutive change in HbA1C by every 4 weeks blood glucose parameters symptomatic hypoglycemia and insulin doses rapid-acting basal and total
To collect 6-month safety data of HMR1964
To collect 6-month safety data of HMR1964
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