drugset / Trial / NCT01867307
Effect of Empagliflozin Kinetics on Renal Glucose Reabsorption in Patients With Type II Diabetes and Healthy Controls
Non-randomizedParallel-groupOpen-labelTreatment
Summary
Single center, 14-day, open-label trial to examine the effect of 25 mg q.d. empagliflozin on kinetics of renal glucose reabsorption in patients diagnosed with type 2 diabetes mellitus and healthy controls
Timeline
- Start
- 2013-06
- Primary completion
- 2015-10
- Completion
- 2015-10
Outcome
Met primary endpoint
registry analysis (superiority or other test); T2DM Patients; p <0.0001; Median Difference (Final Values) -220.0 (95% CI -440.6 to -202.7); Paired t- test; NCT01867307 ↗
registry analysis (superiority or other test); Healthy Subjects; p <0.0001; Median Difference (Final Values) -234.0 (95% CI -312.3 to -201.5); Paired t-test NCT01867307 ↗
paper TmG was further reduced by empagliflozin in both groups on day 14 (by 65 ± 5 and 75 ± 3%, respectively). PMID 28428225 ↗
Publications
- Abdul-Ghani M, Al Jobori H, Daniele G, Adams J, Cersosimo E, Triplitt C, DeFronzo RA. Inhibition of Renal Sodium-Glucose Cotransport With Empagliflozin Lowers Fasting Plasma Glucose and Improves beta-Cell Function in Subjects With Impaired Fasting Glucose. Diabetes. 2017 Sep;66(9):2495-2502. doi: 10.2337/db17-0055. Epub 2017 Jun 13.
- Al-Jobori H, Daniele G, Cersosimo E, Triplitt C, Mehta R, Norton L, DeFronzo RA, Abdul-Ghani M. Empagliflozin and Kinetics of Renal Glucose Transport in Healthy Individuals and Individuals With Type 2 Diabetes. Diabetes. 2017 Jul;66(7):1999-2006. doi: 10.2337/db17-0100. Epub 2017 Apr 20.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Empagliflozin | Small molecule | 25 mg | Oral |