LAPAS Study: Insulin Glargine in Type 2 Diabetes Mellitus
Completed
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Drug: Insulin glargine (LANTUS)
- Registration Number
- NCT00423215
- Lead Sponsor
- Sanofi
- Brief 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%.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1007
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
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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.
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Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients with Type II diabetes Insulin glargine (LANTUS) -
- Primary Outcome Measures
Name Time Method Measure of Glycolysated Haemoglobin (HbA1c) level reduction Delta between the treatment start and the end of the study (i.e. 4 months +/- 2 weeks)
- Secondary Outcome Measures
Name Time Method 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) Investigator assessment At the end of the study (i.e. 4 months +/- 2 weeks) Insulin dose At the end of the study (i.e. 4 months +/- 2 weeks) Patient's satisfaction At the end of the study (i.e. 4 months +/- 2 weeks)
Trial Locations
- Locations (1)
Sanofi-Aventis Administrative Office
🇮🇱Natanya, Israel