Diabetes Mellitus, Type 2
Conditions
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%.
Interventions
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.
Sponsors
Sanofi
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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) |
Countries
Israel
Outcome results
None listed