Extension to Study HMR1964A/3011 in Belgium

December 28, 2007 updated by: Sanofi

Multicenter,Open,Uncontrolled,Clinical Extension Trial in Subjects With Type I Diabetes Previously Participating in 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium
        • Sanofi-Aventis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evolution of efficacy parameters between first study visit (V1) and last study visit (V5)
Time Frame: Mean time interval: 10 months
Mean time interval: 10 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Investigators

  • Study Director: Elke Meyssen, Sanofi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2002

Study Completion (ACTUAL)

April 1, 2004

Study Registration Dates

First Submitted

December 17, 2007

First Submitted That Met QC Criteria

December 17, 2007

First Posted (ESTIMATE)

December 19, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

January 9, 2008

Last Update Submitted That Met QC Criteria

December 28, 2007

Last Verified

December 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HOE901_4046

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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