An Open Label Phase IV Study to Evaluate Dapagliflozin Treatment in Type 2 Diabetes Mellitus Patients With Impaired Renal Function
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|ClinicalTrials.gov Identifier: NCT04620590|
Recruitment Status : Recruiting
First Posted : November 9, 2020
Last Update Posted : September 8, 2021
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Type 2 Impaired Renal Function||Drug: Dapagliflozin 10 MG [Farxiga]||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||17 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||DAPASALT: An Open Label, Phase IV, Mechanistic, Study to Evaluate the Natriuretic Effect of 2-Week Dapagliflozin Treatment in Type 2 Diabetes Mellitus Patients With Impaired Renal Function|
|Actual Study Start Date :||April 20, 2021|
|Estimated Primary Completion Date :||March 15, 2022|
|Estimated Study Completion Date :||April 15, 2022|
Experimental: Treatment Arm
Patients will receive dapagliflozin 10 mg tablets once daily for 14±1 days.
Drug: Dapagliflozin 10 MG [Farxiga]
Dapagliflozin is a stable, reversible, highly selective, and orally active inhibitor of human renal sodium glucose co-transporter 2 (SGLT2), the major transporter responsible for glucose reabsorption in the kidney. Patients will receive one tablet dapagliflozin 10 mg per day for a total period of 14±1 days. This dose is the recommended dose for monotherapy and for add-on combination therapy with other glucose-lowering medicinal products including insulin to improve glycaemic control in T2DM.
- Change in 24-hr sodium excretion [ Time Frame: 24 hours ]To investigate change in 24-hr sodium excretion during dapagliflozin treatment between Baseline (average of Days -3 to -1) and average of Days 2 to 4 within each study group in patients with type 2 diabetes mellitus (T2DM) with impaired renal function.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04620590
|Contact: Suzanne M Milne, BS, MBAfirstname.lastname@example.org|
|Contact: Melissa Atnipemail@example.com|
|David Cherney, CM, PhD||Recruiting|
|Toronto, Ontario, Canada, M5G 2C4|
|Contact: Vesta Lai 416-340-4800 ext 8508 Vesta.Lai@uhn.ca|
|Principal Investigator: David Cherney, MD, PhD|
|Principal Investigator:||Hiddo JL Heerspink||Investigator|