Extension to Study HMR1964A/3011 in Belgium

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00576862
• Other study ID #: HOE901_4046
• Status: Completed
• Phase: Phase 4
• First received: December 17, 2007
• Last updated: December 28, 2007
• Start date: November 2002
• Est. completion date: April 2004

Study information

• Verified date: December 2007
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: April 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Drug:
• INSULIN GLARGINE
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.

Locations

Country	Name	City	State
Belgium	Sanofi-Aventis	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evolution of efficacy parameters between first study visit (V1) and last study visit (V5)		Mean time interval: 10 months