Multicenter,Open,Uncontrolled,Clinical Extension Trial in Subjects With Type I Diabetes Previously Participating in Study HMR1964A/3011 in Belgium

Extension to Study HMR1964A/3011 in Belgium

Sponsors

Lead sponsor: Sanofi

Source 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.

Overall Status Completed
Start Date November 2002
Completion Date April 2004
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
Evolution of efficacy parameters between first study visit (V1) and last study visit (V5) Mean time interval: 10 months
Enrollment 32
Condition
Intervention

Intervention type: Drug

Intervention name: INSULIN GLARGINE

Description: The subjects will continue the treatment with HOE 901 in the same way as they have done in the previous study. Based on the investigator's assessment and the approved SPC in Belgium/Luxembourg, the dosage can be adjusted individually. HOE 901 is to be injected once daily. HOE 901 must not be mixed with any other insulin, including regular human insulin or fast-acting insulin analogues.

Arm group label: 1

Eligibility

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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Elke Meyssen Study Director Sanofi
Location
facility Sanofi-Aventis
Location Countries

Belgium

Verification Date

December 2007

Has Expanded Access No
Number Of Arms 1
Arm Group

Arm group label: 1

Arm group type: Experimental

Study Design Info

Allocation: Randomized

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov