Extension to Study HMR1964A/3011 in Belgium

Sanofi

Status and phase: Completed; Phase 4

Conditions: Diabetes Mellitus

Treatments: Drug: INSULIN GLARGINE

Study type: Interventional

Funder types: Industry

Identifiers

NCT00576862

HOE901_4046

Details and patient eligibility

About

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

Enrollment: 32 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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32 participants in 1 patient group

1

Experimental group

Treatment:

Drug: INSULIN GLARGINE