Extension to Study HMR1964A/3011 in Belgium

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

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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Sanofi-Aventis

Brussels, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

insulin glargine

Drug

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.

Primary outcomes

Evolution of efficacy parameters between first study visit (V1) and last study visit (V5)

Time frame: Mean time interval: 10 months

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

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

Important dates

Study start: 2002
Study completion: 2004
First posted: Dec 19, 2007
Registry last updated: Jan 9, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed