Health Condition 1: null- Type 2 Diabetes Mellitus Health Condition 2: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
None listed
Sponsors
Sanofi India Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and female 2. Age >18 years 3. Known type 2 diabetes for whom an adjunct therapy with basal insulin is appropriate or an adjustment of the current insulin therapy (either basal insulin or premixed insulin) is required according to the treating physician 4. Inadequately controlled because the glycemic goal targeted by the treating physician is not achieved 5. Signed informed consent prior to study entry
Exclusion criteria
Exclusion criteria: 1. History of hypersensitivity to insulin glargine and/or insulin glulisine. 2. Pregnant, breast-feeding or women of childbearing potential not using efficient contraception. 3. Brittle diabetes. 4. Psychiatric or mental disease. 5. Patient unable or unwilling to manage properly the basal bolus regimen. 6. Patient participating to other clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main evaluation criteria: 1. Predictive factors of achieving glycaemic control (as the level of HbA1c targeted by the treating physician) at 6 months 2. Clinical variables a. Age, gender, ethnicity b. Duration of disease: 5 years, [5 â?? 10[, â?¥ 10 years c. Existing cardiovascular risk factors (obesity, HBP, smoking, dyslipidemia, history of cardiovascular disease, etc.) d. Existing diabetes-related complications e. Level of glycemic control at baseline:Timepoint: 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Predictive factors of achieving glycaemic control (as the level of HbA1c targeted by the treating physician) at 12 months 2. Potential factors associated with the choice of the level of HbA1c the treating physician considers appropriate for his patient: clinical and non clinical variables recorded at baseline (see Main evaluation criteria) and criteria related to physicians 3. Glycemic control (level of HbA1C as targeted by the treating physician) at endpoint 4. HbA1c7% at endpoint Timepoint: 12 Months | — |
Countries
Bangladesh, Egypt, India, Israel, Pakistan, Saudi Arabia, South Africa, United Arab Emirates
Contacts
Public ContactMr Ajit Walekar
Sanofi Synthelabo (India) Limited
Outcome results
None listed