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LAPAS Study: Insulin Glargine in Type 2 Diabetes Mellitus

Information source: Sanofi
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Diabetes Mellitus, Type 2

Intervention: Insulin glargine (LANTUS) (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Sanofi

Official(s) and/or principal investigator(s):
Nurit Tweezer-Zaks, M.D., Study Director, Affiliation: Sanofi


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%.

Clinical Details

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%

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome: Measure of Glycolysated Haemoglobin (HbA1c) level reduction

Secondary outcome:

Measure of Fasting Blood Glucose (FBG) level reduction

Investigator assessment

Insulin dose

Patient's satisfaction


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


Inclusion Criteria:

- Patients with type 2 diabetes mellitus,

- Having been treated with any other insulin, but who did not reach the target of


- 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.

Locations and Contacts

Sanofi-Aventis Administrative Office, Natanya, Israel
Additional Information

Starting date: March 2006
Last updated: June 12, 2009

Page last updated: August 23, 2015

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