LAPAS Study: Insulin Glargine in Type 2 Diabetes Mellitus

Sanofi1,007 enrolled

Overview

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%.

Study Type

OBSERVATIONAL

Enrollment

1,007

Conditions

Diabetes Mellitus, Type 2

Interventions

Insulin glargine (LANTUS)DRUG

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 (1)

Sanofi-Aventis Administrative Office

Netanya, Israel

Outcomes

Primary Outcomes

Measure of Glycolysated Haemoglobin (HbA1c) level reduction

Time frame: Delta between the treatment start and the end of the study (i.e. 4 months +/- 2 weeks)

Secondary Outcomes

Measure of Fasting Blood Glucose (FBG) level reduction

Time frame: Delta between the treatment start and the end of the study (i.e. 4 months +/- 2 weeks)

Investigator assessment

Time frame: At the end of the study (i.e. 4 months +/- 2 weeks)

Insulin dose

Time frame: At the end of the study (i.e. 4 months +/- 2 weeks)

Patient's satisfaction

Time frame: At the end of the study (i.e. 4 months +/- 2 weeks)

Data from ClinicalTrials.gov

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