Extension to Study HMR1964A/3011 in Belgium

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00576862
First received: December 17, 2007
Last updated: December 28, 2007
Last verified: December 2007
  Purpose

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


Condition Intervention Phase
Diabetes Mellitus
Drug: INSULIN GLARGINE
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multicenter,Open,Uncontrolled,Clinical Extension Trial in Subjects With Type I Diabetes Previously Participating in Study HMR1964A/3011 in Belgium

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Evolution of efficacy parameters between first study visit (V1) and last study visit (V5) [ Time Frame: Mean time interval: 10 months ]

Enrollment: 32
Study Start Date: November 2002
Study Completion Date: April 2004
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00576862

Locations
Belgium
Sanofi-Aventis
Brussels, Belgium
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Elke Meyssen Sanofi
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00576862     History of Changes
Other Study ID Numbers: HOE901_4046
Study First Received: December 17, 2007
Last Updated: December 28, 2007
Health Authority: Belgium: Institutional Review Board

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glargine
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 30, 2014