Health Condition 1: E11- Type 2 diabetes mellitus
Conditions
Interventions
Intervention1: NA: NA
Control Intervention1: NA: NA
Sponsors
Sun Pharma Laboratories Limited
Eligibility
Inclusion criteria
Inclusion criteria: Male and female patients of age =18 years. Patients diagnosed with type-2 diabetes mellitus. Patients with HbA1c =7% at baseline visit Patients prescribed dapagliflozin and sitagliptin FDC in any visit other than baseline visit on the EMR platform. Patients with EMR data captured for more than one visit.
Exclusion criteria
Exclusion criteria: Patients diagnosed with type-1 diabetes mellitus. Patients are on insulin or any other injectable antidiabetic medication like glucagon-like peptide-1 (GLP -1) agonists. Patients with incomplete medical records with respect to the required study parameters.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in HbA1c from baseline to 3 months in patients with HbA1c =8% at baselineTimepoint: Baseline to 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Drug utilization patterns (Dose strength, frequency and duration of administration) of dapagliflozin and sitagliptin FDC.Timepoint: NA;Mean change in body weight from baseline to 3 months and 6 months in patients with HbA1c greater than 8% with BMI greater than 23 kg/m2 at baselineTimepoint: Baseline to 3 and 6 months;Mean change in body weight from baseline to 3 months and 6 months in patients with HbA1c greater than 8% with BMI greater than 23 kg/m2 at baseline, upon stratification of patients by the dose of dapagliflozin and sitagliptin FDCTimepoint: Baseline to 3 and 6 months;Mean change in body weight from baseline to 3 months and 6 months in patients with HbA1c greater than 8% with BMI greater than 25 kg/m2 at baselineTimepoint: Baseline to 3 and 6 months;Mean change in body weight from baseline to 3 months and 6 months in patients with HbA1c greater than or equal to 8% with BMI greater than 25 kg/m2 at baseline, upon stratification of patients by the dose of dapagliflozin and sitagliptin FDCTimepoint: Baseline to 3 and 6 months;Mean change in fasting glucose level from baseline to 3 months and 6 months in patients with HbA1c =8% at baselineTimepoint: Baseline to 3 and 6 months;Mean change in HbA1c from baseline to 3 months and 6 months in patients with HbA1c =7% at baselineTimepoint: Baseline to 3 and 6 months;Mean change in HbA1c from baseline to 3 months and 6 months in patients with HbA1c =8% at baselineTimepoint: Baseline to 3 and 6 months;Mean change in HbA1c from baseline to 3 months in patients with HbA1c =7% at baselineTimepoint: Baseline to 3 months;Mean change in HbA1c from baseline to 3 months in patients with HbA1c =8% at baseline, upon stratification of patients by age, gender, weight/body mass index (BMI), baseline oral antidiabetic drug (OAD) therapy, dose of dapagliflozin and sitagliptin FDC and comorbidities (cardiovascular, renal and others)Timepoint: Baseline to 3 months;Mean change in postprandial glucose level in patients with HbA1c >8% | — |
Countries
India
Contacts
Public ContactMs Colette Pinto
Sun Pharma Laboratories Limited
Outcome results
None listed