Overview

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 Mellit

Status:
Completed

Trial end date:
2004-02-01

Target enrollment:

Participant gender:

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.

Phase:

Phase 3

Details

Lead Sponsor:

Sanofi

Treatments:

Insulin
Insulin Glargine
Insulin, Globin Zinc
Insulin, Isophane
Isophane insulin, beef
Isophane Insulin, Human