Extension to Study HMR1964A/3011 in Belgium

Phase 4

Completed

• Conditions: Diabetes Mellitus
• Interventions: Drug: INSULIN GLARGINE

• Registration Number: NCT00576862
• Lead Sponsor: Sanofi

Brief Summary

The purpose of this trial is to allow patients to continue on HOE 901 until launch and to gather additional long-term safety data.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-11
• Study Completion: 2004-04
• Status Verified: 2007-12
• Study First Submitted: 2007-12-17
• Study First Submitted QC: 2007-12-17
• Study First Posted: 2007-12-19
• Last Update Submitted: 2007-12-28
• Last Update Posted: 2008-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• Subjects treated with HOE901 and who, in the judgement of the investigator, have benefited from the use of HOE 901 in a previous clinical study with HOE 901.
• Subjects treated with HOE 901 in a previous clinical study with HOE 901 for whom a change of basal insulin would destabilise glucose metabolism.
• Subjects who are likely to comply with the investigator's instructions.

Read More

Exclusion Criteria

• Evidence of an uncooperative attitude.
• Subject not on adequate contraception, or who is pregnant, or breast feeding.
• Subject unable to understand informed consent.
• Patient receiving or likely to receive HOE901 treatment outside of SPC or PI recommendations.
• Subject becomes pregnant or is planning to become pregnant.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	INSULIN GLARGINE	-

Primary Outcome Measures

Name	Time	Method
Evolution of efficacy parameters between first study visit (V1) and last study visit (V5)	Mean time interval: 10 months

Trial Locations

Locations (1)

Sanofi-Aventis; 🇧🇪 Brussels, Belgium