drugset / Trial / NCT03152084
The Study Will Evaluate Average 24-hr Sodium Excretion During Dapagliflozin Treatment in Patients With Type 2 Diabetes Mellitus With Preserved or Impaired Renal Function or Non-diabetics With Impaired Renal Function.
Non-randomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to evaluate how dapagliflozin mechanism of action is impacted by Type 2 Diabetes Mellitus status and kidney function
Timeline
- Start
- 2017-07-12
- Primary completion
- 2020-03-20
- Completion
- 2020-03-20
Outcome
Missed primary endpoint
Stopped (Enrollment): “Poor recruitment.”
registry analysis (other test); Group 2; p = 0.4462; Least square mean -5.21 (95% CI -19.542 to 9.120); Mixed Models Analysis; note: Start of treatment vs baseline NCT03152084 ↗
paper Mean (SD) baseline sodium excretion (150 [32] mmol/24-h) did not significantly change during treatment (change at ST: -7.0 mmol/24-h [95% CI -22.4, 8.4]; PMID 33318125 ↗
Publications
- Scholtes RA, Muskiet MHA, van Baar MJB, Hesp AC, Greasley PJ, Hammarstedt A, Karlsson C, Hallow KM, Danser AHJ, Heerspink HJL, van Raalte DH. The Adaptive Renal Response for Volume Homeostasis During 2 Weeks of Dapagliflozin Treatment in People With Type 2 Diabetes and Preserved Renal Function on a Sodium-Controlled Diet. Kidney Int Rep. 2022 Mar 4;7(5):1084-1092. doi: 10.1016/j.ekir.2022.02.023. eCollection 2022 May.
- Scholtes RA, Muskiet MHA, van Baar MJB, Hesp AC, Greasley PJ, Karlsson C, Hammarstedt A, Arya N, van Raalte DH, Heerspink HJL. Natriuretic Effect of Two Weeks of Dapagliflozin Treatment in Patients With Type 2 Diabetes and Preserved Kidney Function During Standardized Sodium Intake: Results of the DAPASALT Trial. Diabetes Care. 2021 Feb;44(2):440-447. doi: 10.2337/dc20-2604. Epub 2020 Dec 14.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dapagliflozin | Small molecule | 10 mg | — |