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

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ClinicalTrials.gov Identifier: NCT00576368
Recruitment Status : Completed
First Posted : December 19, 2007
Last Update Posted : January 9, 2008
Sponsor:
Information provided by:
Sanofi

Brief Summary:
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 or disease Intervention/treatment Phase
Diabetes Mellitus Drug: INSULIN GLARGINE Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4464 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : June 2003
Actual Study Completion Date : April 2004

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




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


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00576368


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

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ClinicalTrials.gov Identifier: NCT00576368     History of Changes
Other Study ID Numbers: HOE901_5007
First Posted: December 19, 2007    Key Record Dates
Last Update Posted: January 9, 2008
Last Verified: December 2007

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