Extension to Study HMR1964A/3011 in Belgium

• Status: Completed
• Trial end date: 2004-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Insulin; Insulin Glargine

Criteria

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.

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.