Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2026-02-20 @ 5:57 PM
Study NCT ID:
NCT00537251
Status:
COMPLETED
Last Update Posted:
2007-10-01
First Post:
2007-09-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
32 Week, Open, Randomized, 2 Way Cross Over Multicentre Trial to Compare Safety & Efficacy of Combination of HOE901 Insulin Analogue Once Daily at Bedtime + Lispro Insulin Before Meals vs NPH Insulin (Twice a Day) + Regular in Type 1 Diabetes Mellitus
Sponsor:
Sanofi
Organization:
Study Overview
Official Title:
32-Week, Open, Randomized, Cross-Over, Local, Multicenter Clinical Trial Comparing Insulin Glargine in Combination With Insulin Analogue (Insulin Lispro) to NPH Insulin in Combination With Regular Insulin in Type 1 Diabetes Mellitus Patients in an Intensified Insulin Regimen.
Status:
COMPLETED
Status Verified Date:
2007-09
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 compare the efficacy (in terms of metabolic control evaluated through HbA1c levels) of treatment with insulin glargine as basal insulin and insulin analogue (insulin lispro) as mealtime insulin with a regimen of insulin NPH as basal insulin with regular insulin, as mealtime insulin, after a 16 week treatment phase with each regimen and to compare the safety of both treatments, evaluated through hypoglycemic rates.
Detailed Description:
Multicenter, open-label, randomized (allocation ratio 1:1), cross-over with two treatment phases of 16 weeks each in two treatment groups:
* Study arm with insulin glargine + insulin lispro (phase 1) and insulin NPH + regular insulin (phase 2)
* Insulin NPH + regular insulin (phase 1) and insulin glargine + insulin lispro (phase 2)
* Study arm with insulin glargine + insulin lispro (phase 1) and insulin NPH + regular insulin (phase 2)
* Insulin NPH + regular insulin (phase 1) and insulin glargine + insulin lispro (phase 2)
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: