drugset / Trial / NCT05359432
Comparison of Empaglifozin and Vildagliptin in Type 2 Diabetes Mellitus
RandomizedParallel-groupOpen-labelTreatment
Summary
The aim of this study is to perform a comparison of the efficacy and safety of empagliflozin and vildagliptin in patients with Type 2 Diabetes Mellitus open labelled, multi-centric, parallel, randomized control trial In Type 2 Diabetes patients, impact of empagliflozin (10 mg once or twice daily) versus vildagliptin (50 mg once or twice daily) assessed for Efficacy \& safety parameters to be measured at both the baseline and 24-week visits.
Timeline
- Start
- 2020-07-01
- Primary completion
- 2021-08-10
- Completion
- 2021-08-18
Publications
- Background Saeedi P, Petersohn I, Salpea P, Malanda B, Karuranga S, Unwin N, Colagiuri S, Guariguata L, Motala AA, Ogurtsova K, Shaw JE, Bright D, Williams R; IDF Diabetes Atlas Committee. Global and regional diabetes prevalence estimates for 2019 and projections for 2030 and 2045: Results from the International Diabetes Federation Diabetes Atlas, 9th edition. Diabetes Res Clin Pract. 2019 Nov;157:107843. doi: 10.1016/j.diabres.2019.107843. Epub 2019 Sep 10.
- Background Deshpande AD, Harris-Hayes M, Schootman M. Epidemiology of diabetes and diabetes-related complications. Phys Ther. 2008 Nov;88(11):1254-64. doi: 10.2522/ptj.20080020. Epub 2008 Sep 18.
- Background American Diabetes Association. Diagnosis and classification of diabetes mellitus. Diabetes Care. 2005 Jan;28 Suppl 1:S37-42. doi: 10.2337/diacare.28.suppl_1.s37. No abstract available.
- Background Strodl E, Kenardy J. Psychosocial and non-psychosocial risk factors for the new diagnosis of diabetes in elderly women. Diabetes Res Clin Pract. 2006 Oct;74(1):57-65. doi: 10.1016/j.diabres.2006.02.011. Epub 2006 Apr 11.
- Background Lin YK, Gao B, Liu L, Ang L, Mizokami-Stout K, Pop-Busui R, Zhang L. The Prevalence of Diabetic Microvascular Complications in China and the USA. Curr Diab Rep. 2021 Apr 9;21(6):16. doi: 10.1007/s11892-021-01387-3.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Empagliflozin | Small molecule | 10 mg | — |
| Subject | Vildagliptin | Other / unclassified | 50 mg | — |