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

Phase 3

Completed

• Conditions: Diabetes Mellitus, Type 1

• Registration Number: NCT00537251
• Lead Sponsor: Sanofi

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 Timeline

• Study Start: 2001-11
• Study Completion: 2004-02
• Status Verified: 2007-09
• Study First Submitted: 2007-09-28
• Study First Submitted QC: 2007-09-28
• Last Update Submitted: 2007-09-28
• Study First Posted: 2007-10-01
• Last Update Posted: 2007-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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.

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
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 .	after 16 weeks of treatment with each treatment regime