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NCT02911792: Hyper

Effect of Farxiga on Renal Function and Size in Type 2 Diabetic Patients With Hyperfiltration

Completed Phase 4 Results posted Last updated 30 November 2023
What this trial tests

Phase 4 trial testing Dapagliflozin in Diabetes Mellitus, Type 2 in 72 participants. Completed in 11 July 2023.

Timeline
20 December 2016
Primary endpoint
11 July 2023
11 July 2023

Quick facts

Lead sponsorThe University of Texas Health Science Center at San Antonio
PhasePhase 4
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment72
Start date20 December 2016
Primary completion11 July 2023
Estimated completion11 July 2023
Sites2 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

The University of Texas Health Science Center at San Antonio

Who can join

Adults 30 to 70, any sex, with Diabetes Mellitus, Type 2. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

GFR (Glomerular Filtration Rate) Change After Treatment Primary · 4 months

Change from baseline in GFR after treatment from baseline to 4 months

GroupValue95% CI
Dapagliflozin/Hyperfiltration22± 6
Metformin/Hyperfiltration1± 5
Dapagliflozin/Normofiltration8± 3
Metformin/Normofiltration0± 4

Adverse events — posted to ClinicalTrials.gov

Time frame: All adverse events were recorded during the entire 4 months period of the study. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Dapagliflozin/Hyperfiltration
Serious: 0/15 (0%)
Deaths: 0/15
Metformin/Hyperfiltration
Serious: 0/15 (0%)
Deaths: 0/15
Dapagliflozin/Normofiltration
Serious: 0/15 (0%)
Deaths: 0/15
Metformin/Normofiltration
Serious: 0/15 (0%)
Deaths: 0/15
Other adverse events (2 terms — click to expand)

ReactionSystemDapagliflozin/Hyperfiltrat…Metformin/HyperfiltrationDapagliflozin/Normofiltrat…Metformin/Normofiltration
Genital Mycotic InfectionInfections and infestations
Mild HypoglycemiaEndocrine disorders

Data from ClinicalTrials.gov NCT02911792 adverse events section.

Sponsor's own description

The investigators propose to treat newly diagnosed, hyperfiltering T2DM patients with or without microalbuminuria with dapagliflozin or metformin for 4 months. The metformin-treated group will serve as controls for improved glycemic control, since the investigators have shown that insulin therapy to normalize A1c reduces hyperfiltration and kidney size in T1DM patients.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Glomerular hyperfiltration as a therapeutic target for CKD.
    Kanbay M, Copur S, Bakir CN, Covic A, et al · · 2024 · cited 48× · PMID 38308513 · DOI 10.1093/ndt/gfae027

Verify or expand the search:

Other trials of Dapagliflozin

Trials testing the same drug.

Other recruiting trials for Diabetes Mellitus, Type 2

Currently open trials in the same condition.

Other The University of Texas Health Science Center at San Antonio trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02911792.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing