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
Information source: Sanofi-Aventis
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diabetes Mellitus, Type 1
Intervention: Insulin glargine (Drug)
Phase: Phase 3
Sponsored by: Sanofi-Aventis
Official(s) and/or principal investigator(s):
Jose Taboada Mosquera, Study Director, Affiliation: Sanofi-Aventis
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.
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.
Study design: Treatment, Randomized, Open Label, Crossover Assignment, Safety/Efficacy Study
Primary outcome: Compare efficacy of insulin glargine & short acting insulin (Lispro), NPH insulin regime as basal insulin and regular insulin for meal insulin for metabolic control, evaluated by means of HbA1c .
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)
Minimum age: 18 Years.
Maximum age: 65 Years.
- Subjects with type 1 diabetes mellitus
- 18-65 years of age
- C-Peptide negative
- Treated at least for 6 months with multiple daily doses of insulin and with HbA1c
greater than or equal to 7. 0% and less than or equal to 9. 5% and a BMI less than or
equal to 35 kg/m².
- Women of childbearing potential must have a negative pregnancy test in visit 1 and
must use an effective contraceptive method during the study.
Locations and Contacts
Starting date: November 2001
Ending date: February 2004
Last updated: September 28, 2007