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

Sanofi

Status and phase

Completed

Phase 3

Conditions

Diabetes Mellitus, Type 1

Treatments

Drug: Insulin glargine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00537251

HOE901_4023

Details and patient eligibility

About

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.

Full 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)

Enrollment

80 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

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.