Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Intervention1: Not Applicable: Not Applicable
Control Intervention1: Not Applicable: Not Applicable
Sponsors
Sanofi India Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female aged = 18 years 2. Insulin-naïve type 2 diabetes patients, uncontrolled (HbA1c > 7%), on at least 1 oral antidiabetic drug (OAD) for a minimum period of 6 months, initiated on insulin glargine (Lantus® / Toujeo®) in out-patient primary care settings 3. Signed informed consent form. Note: Insulin glargine should be administered up to 7 days prior to informed consent or within 2 days after informed consent independent of this study
Exclusion criteria
Exclusion criteria: 1. Known cases of type 1 diabetes mellitus and secondary diabetes. 2. Clinically significant acute major organ or systemic disease or other condition judged by the investigator that would create difficulty for the 6-month follow-up. 3. Current or planned pregnancy or lactating women 4. Patients on an investigational drug or have participated in a clinical trial in the previous 3 months 5. Contraindication to Lantus® and Toujeo® according to local product labelling 6. Patents requiring short-term insulin therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in HbA1c from baseline to 6 monthsTimepoint: Mean change in HbA1c from baseline to 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Number of adverse events and serious adverse events and hypoglycemic events in overall population 2. Change in insulin dose in overall population. 3. Change in body weight in overall population. 4. Physician satisfaction scores at 6 months in overall population. 5. Patient treatment-satisfaction scores at 6 months in overall populationTimepoint: 03 Months 06 Months | — |
Countries
India
Contacts
Public ContactVijay Mandal
Sanofi Healthcare India Private Limited
Outcome results
None listed