Diabetes Mellitus, Type 2
Conditions
Brief summary
Primary objective: * To observe the efficacy of the forced titration to reach good glycemic control in Lantus treated patients Secondary objectives: * To assess the forced titration on physician and patient satisfaction * To evaluate the impact of training tools by means of patient profile
Interventions
DRUGInsulin glargine
The dose is titrated according to patient needs
Sponsors
Sanofi
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* T2 insulin naïve patients * Patients whom their physician is considering initiation of Lantus treatment * Poor glycemic control 7,5 %10 % * T2 treatment with OADs more than 3 months * BMI\<40 kg/m2
Exclusion criteria
* Impaired renal function (Cr\>2mg/dl or current renal dialysis) * Acute or chronic metabolic acidosis * Active liver disease or serum ALT or AST \>2,5 than normal * History of hypoglycemia unawareness * Diabetic retinopathy with surgery in the previous 3 months or planned within 3 months after study entry * Pregnancy, breast feeding 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 |
|---|---|
| Time to dose titration | after treatment end (6 months) |
| HbA1c, FBG | after treatment end (6 months) |
| Final dose | after treatment end (6 months) |
| Number of dose adjustment | after treatment end (6 months) |
Secondary
| Measure | Time frame |
|---|---|
| Hypoglycemia | after treatment end (6 months) |
| Noctural hypoglycemia | after treatment end (6 months) |
| DTSQ | after treatment end (6 months) |
| Physician Satisfaction Questionnaire | after treatment end (6 months) |
Countries
Turkey (Türkiye)
Outcome results
None listed