baSal BoluS Therapy in patIenTs With TypE 1 Diabetes Mellitus — SUBSTITUTE  

Diabetes Mellitus, Type 1 Clinical Trial

Official title: Phase IV, Multicenter, International, Non-comparative, Open Label Study of Efficacy and Safety of Basal Bolus Therapy (Insulin Glargine + Insulin Glulisine) in Patients With T1 Diabetes Previously Uncontrolled on Any Insulin Regimen.

Status Completed

Clinical Trial Summary

Primary Objective:

To evaluate the efficacy of the association Lantus (once-a-day, od) Apidra (thrice-a-day, tid) in terms of change HbA1c from baseline to end of study (week 24), in patients with Type 1 Diabetes Mellitus (T1DM).

Secondary Objectives:

To evaluate:

• The change of hemoglobin A1c (HbA1c) from baseline to week 12

• The percentage of patients with HbA1c < 7% at week 12 and week 24

• The FBG and the 7-point self monitoring of blood glucose (SMBG) at baseline, week 12 and week 24

• The daily dose for both insulin glulisine insulin glargine at baseline, week 12 and week 24

• The incidence of symptomatic hypoglycemias

• Adverse events

Clinical Trial Description

After a two-week run-in period patients will enter a six-month treatment period.

Estimated study duration per patient : 26 weeks (including a 2-week run-in period). ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1

• NCT number: NCT01204593
• Study type: Interventional
• Source: Sanofi
• Status: Completed
• Phase: Phase 4
• Start date: November 2010
• Completion date: January 2013