Health Condition 1: E11- Type 2 diabetes mellitus
Conditions
Interventions
Intervention1: NA: NA
Control Intervention1: NA: NA
Sponsors
Sun Pharma Laboratories Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Male and female patients with type-2 diabetes mellitus =18 years of age. Patients prescribed with sitagliptin alone or with other oral antidiabetic medications OR patients prescribed with sitagliptin + metformin FDC alone or with other oral anti-diabetic medications. Patients with EMR data captured for more than one visit.
Exclusion criteria
Exclusion criteria: Patients with type-1 diabetes mellitus. Patients 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 in patients with HbA1c =7% at baseline in Sitagliptin arm. Mean change in HbA1c in patients with HbA1c =7% at baseline in Sitagliptin + Metformin FDC arm.Timepoint: Baseline to 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Drug utilization patterns of Sitagliptin, Sitagliptin and Metformin FDC arm.Timepoint: NA;Mean change in body weight changes from baseline to 3 months, 6 months and 9 months in patients with HbA1c =7% at baseline.Timepoint: Baseline to 3, 6 and 9 months;Mean change in HbA1c from baseline at the end of 3 months, 6 months and 9 months in patients with baseline HbA1c =7.5% in Sitagliptin and Metformin FDC arm.Timepoint: Baseline to 3, 6 and 9 months;Mean change in HbA1c from baseline to 3 months in patients with baseline HbA1c =7.5% in Sitagliptin arm.Timepoint: Baseline to 3 months;Mean change in HbA1c from baseline to 9 months in patients with HbA1c =7% at baseline in Sitagliptin and Metformin FDC arm.Timepoint: Baseline to 9 months;Mean change in HbA1c from baseline to 9 months in patients with HbA1c =7% at baseline in Sitagliptin arm.Timepoint: Baseline to 9 months;Mean change in HbA1c from baseline to of 3 months in patients with baseline HbA1c =7.5% in Sitagliptin and Metformin FDC arm.Timepoint: Baseline to 3 months;Mean change in HbA1c from baseline to of 3 months, 6 months and 9 months in patients with baseline HbA1c =7.5% in Sitagliptin arm.Timepoint: Baseline to 3, 6 and 9 months;Mean change in HbA1c in patients with baseline HbA1c =7% in sitagliptin arm.Timepoint: Baseline to 3, 6 and 9 months;Mean change in HbA1c in patients with HbA1c =7% at baseline in both arms.Timepoint: Baseline to 3 months;Mean change in HbA1c with baseline HbA1c =7% in Sitagliptin and Metformin FDC armTimepoint: Baseline to 3, 6 and 9 months;Mean change in PPBG and FBG from baseline to 3 months in patients with baseline HbA1c =7% in Sitagliptin and Metformin FDC arm.Timepoint: Baseline to 3 months;Mean change in PPBG and FBG from baseline to 3 months in patients with baseline HbA1c =7% in Sitagliptin arm.Timepoint: Baseline to 3 months;Proportion of patients achieving HbA1c <7% in Sitagliptin and Metformin FDC arm.Timepoint: NA;Proportions of patients achieving HbA1c <7% in Sitagl | — |
Countries
India
Contacts
Public ContactMs Colette Pinto
Sun Pharma Laboratories Limited
Outcome results
None listed