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NCT00576368 Clinical Trial

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

Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00576368
Other study ID # HOE901_5007
Secondary ID
Status Completed
Phase Phase 4
First received December 17, 2007
Last updated December 28, 2007
Start date June 2003
Est. completion date April 2004

Study information
Verified date December 2007
Source Sanofi
Contact n/a
Is FDA regulated No
Health authority Belgium: Institutional Review Board
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 4464
Est. completion date April 2004
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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:

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
Belgium Sanofi-Aventis Brussels

Sponsors (1)
Lead Sponsor Collaborator
Sanofi

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary Glycemic status (Fasting Blood Glucose, Fasting Plasma Glucose, and HbA1C as done in routine medical practice) at least 3months
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