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
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%.
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 reductionInvestigator assessment Insulin dose Patient's satisfaction
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Sanofi-Aventis Administrative Office, Natanya, Israel
Additional Information
Starting date: March 2006
Last updated: June 12, 2009
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