None listed
Conditions
Interventions
Intervention1: vildagliptin + metformin FDC: vildagliptin 50 mg
metformin 500mg, 850 mg, 1000mg
Intervention2: Vildagliptin: 50 mg bid
Control Intervention1: NIL: NIL
Sponsors
Novartis Healthcare Pvt LtdSandoz house Dr ABRoad WorliMumbai
Eligibility
Inclusion criteria
Inclusion criteria: ? Male or female outpatients (age ≥ 18 years) with a diagnosis of T2DM who have, within the previous 4 weeks, been prescribed vildagliptin on top of metformin therapy (free dose combination or SPC) or (only if approved in the relevant country) are OAD drug naïve patients who have been prescribed vildagliptin as initial monotherapy. ? Patients who consent to have their data collected. Patients will not need to consent to taking the drug, as their treatment is decided before entry into the study and is part of their medical care
Exclusion criteria
Exclusion criteria: Patients with an HbA1c value greater than 10%Contraindications mentioned in the Summary of Product Characteristics for vildagliptin, metformin and vildagliptin plus metformin SPC
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the percent change from baseline (BL) in HbA1c after 24 weeks treatment with vildagliptin as monotherapy or in addition to metformin or vildagliptin plus metformin (SPC) in adult T2DM patientsTimepoint: after 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To describe the demographics and baseline characteristics of patients prescribed vildagliptin as monotherapy or in addition to metformin or vildagliptin plus metformin (SPC) 2. To assess the number of confirmed hypoglycemic events and the incidence rate of patients who develop confirmed hypoglycemic events and compare within historical control, EDGE study. 3. To assess the change from baseline (BL) in HbA1c after 24 weeks treatment in sub-populations (BL HbA1c < 8%, 8-10%, elderly vs young adults, obese vs non obese patients, ethnic subgroups) 4. To assess the percentage of patients reaching the glycemic target of (i) HbA1c &#8804; 6.5% and (ii) HbA1c &#8804; 7.0%, after 24 weeks treatment, in the overall study population and in sub populations. 5. To assess the change from BL in weight, body mass index (BMI) and waist circumference after 24 weeks treatment 6. To evaluate the proportion of patients who discontinue treatment due to unsatisfactory effectiveness or the need for additional oral antidiabetic drug (OAD)/insulin in the overall study population and in sub populations 7. To evaluate the mean dose of metformin the patients were taking when the physician decided to add vildagliptin in the entire population and in subpopulations 8. To assess the safety profile of vildagliptin as monotherapy or in addition to metformin or vildagliptin plus metformin SPC in real life conditions relative to an historical contro 9. To assess the proportion of patients that discontinue treatment due to adverse events (AE) and serious adverse events (SAEs) in real life conditions relative to an historical control. 10. To assess the proportion of patients that discontinue treatment due to any other reason in real life conditions relative to an historical control 11. To assess the effect of vildagliptin as monotherapy or in addition to metformin or vildagliptin plus metformin SPC in real life conditions on individual tolerability factors (body weight, peripheral edema, h | — |
Countries
India
Contacts
Public ContactDr Apurva Gawai
Medical Advisor
Outcome results
None listed