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NCT00423215 Clinical Trial

LAPAS Study: Insulin Glargine in Type 2 Diabetes Mellitus

Diabetes Mellitus, Type 2 Clinical Trial

Official title:
An Open Therapeutic Observational Evaluation of the Efficacy and Safety Profile of Lantus in Everyday Medical Practice in Type 2 Diabetes Mellitus Patients, Who Start Receiving Lantus - Treated With Any Other Insulin, With A1c>7%

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00423215
Other study ID # HOE901_5062
Secondary ID
Status Completed
Phase Phase 4
First received January 17, 2007
Last updated June 12, 2009
Start date March 2006
Est. completion date May 2008

Study information
Verified date June 2009
Source Sanofi
Contact n/a
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Observational

Clinical Trial Summary

The objective of this protocol is to confirm the efficacy and safety profile of Lantus in every day medical practice, in type 2 diabetic patients, have been treated with any other insulin but who did not reach the target of A1c = 7%.

Recruitment information / eligibility
Status Completed
Enrollment 1007
Est. completion date May 2008
Est. primary completion date May 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients with type 2 diabetes mellitus,

- Having been treated with any other insulin, but who did not reach the target of A1c=7%.

- Ability and willingness to perform Self Monitoring Blood Glucose measurement

Exclusion Criteria:

- Will follow the prescribing information (Summary of Product Characteristics).

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Drug:
• Insulin glargine (LANTUS)
The patients will receive Lantus administered by subcutaneous injection, once daily at any time but at the same time each day. Treatment duration: 4 months.

Locations
Country Name City State
Israel Sanofi-Aventis Administrative Office Natanya

Sponsors (1)
Lead Sponsor Collaborator
Sanofi

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary Measure of Glycolysated Haemoglobin (HbA1c) level reduction Delta between the treatment start and the end of the study (i.e. 4 months +/- 2 weeks) No
Secondary Measure of Fasting Blood Glucose (FBG) level reduction Delta between the treatment start and the end of the study (i.e. 4 months +/- 2 weeks) No
Secondary Investigator assessment At the end of the study (i.e. 4 months +/- 2 weeks) No
Secondary Insulin dose At the end of the study (i.e. 4 months +/- 2 weeks) No
Secondary Patient's satisfaction At the end of the study (i.e. 4 months +/- 2 weeks) No
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