Health Condition 1: null- Type 2 Diabetes Mellitus Health Condition 2: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Control Intervention1: NA-Product Registry: NIL
Sponsors
Sanofi India Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Signed patient informed consent; 2. Type 2 diabetes mellitus; 3. Treated with at least 1 OAD for at least 6 months; 4. Legal age of adulthood, but at least >=18 years; 5. HbA1c >7.0 % and 6. Physiciansâ?? decision in accordance with the current local guidelines to add basal insulin glargine U300 to an existing OAD regimen
Exclusion criteria
Exclusion criteria: 1. Diabetes mellitus other than type 2; 2. Existing or previous treatment with insulin or other injectable antidiabetic drugs. The following is allowed: - Previous short-term insulin treatment due to an intercurrent medical condition, with treatment duration not exceeding 10 concurrent days in the past year; - Previous insulin treatment of gestational diabetes, if the patient has discontinued insulin treatment more than a year ago. 3. Contraindication to insulin glargine U300 according to local product labelling; 4. Pregnancy, breastfeeding or pregnancy planned during the course of the study; 5. Drug or alcohol abuse within the past year; 6. Concomitant disease with life expectancy of less than 1 year; 7. Concomitant participation in a clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of patients achieving the predefined individualized HbA1c goal at 6th monthTimepoint: 6th Month | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy endpoints: 1.Percentage of patients achieving the predefined individualized HbA1c goal at Months 3 and 12; 2. Percentage of patients with HbA1c 7% at Months 3, 6 and 12; 3. Percentage of patients achieving an HbA1c 7.5% in patients over 65 years at Month 3, 6 and 12; 4. Percentage of patients reaching predefined individualized HbA1c goal at Months 3, 6 and 12 depending on baseline HbA1c value (8%, 8% to 10% and 10%);Timepoint: 3, 6 and 12 months | — |
Countries
Colombia, Egypt, India, Indonesia, Israel, Jordan, Kazakhstan, Kuwait, Lebanon, Mexico, Peru, Philippines, Qatar, Russian Federation, Saudi Arabia, Singapore, Taiwan, Thailand, Ukraine, United Arab Emirates
Contacts
Public ContactEkata Shah
Sanofi India Limited
Outcome results
None listed