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An Open Therapeutic Project to Confirm the Efficacy Tolerability and Safety Profile of Lantus in Everyday Medical Practice

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00576368
First received: December 17, 2007
Last updated: December 28, 2007
Last verified: December 2007
History of Changes
  Purpose

The objective of this survey on this registered product is to confirm the efficacy, and safety profile of Lantus in every day medical practice. This program will also help to obtain information about the use of the insulin titration regimen and handling of the Lantus insulin analogue.


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: An Open Therapeutic Project to Confirm the Efficacy Tolerability and Safety Profile of Lantus in Everyday Medical Practice

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Glycemic status (Fasting Blood Glucose, Fasting Plasma Glucose, and HbA1C as done in routine medical practice) [ Time Frame: at least 3months ]

Enrollment: 4464
Study Start Date: June 2003
Study Completion Date: April 2004
Arms Assigned Interventions
Experimental: 1 Drug: INSULIN GLARGINE
The physician will be guided by the prescribing information outlined in the summary of product characteristics. The administration will be done by once daily subcutaneous injection.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All newly diagnosed diabetics and existing diabetics uncontrolled on other anti-diabetic therapy, where treatment with basal insulin is required to control hyperglycaemia, and who the treating investigator considers may benefit from the treatment with Lantus, could enter in this program.

Exclusion Criteria:

-

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00576368

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

No publications provided

ClinicalTrials.gov Identifier: NCT00576368     History of Changes
Other Study ID Numbers: HOE901_5007
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 May 21, 2013