MedPath

Dapagliflozin

Generic Name
Dapagliflozin
Brand Names
Edistride, Farxiga, Forxiga, Qtern, Qternmet, Xigduo, Dapagliflozin Viatris
Drug Type
Small Molecule
Chemical Formula
C21H25ClO6
CAS Number
461432-26-8
Unique Ingredient Identifier
1ULL0QJ8UC
Background

Dapagliflozin is a sodium-glucose cotransporter 2 (SGLT2) inhibitor, and it was the first SLGT2 inhibitor to be approved. indicated for managing diabetes mellitus type 2. When combined with diet and exercise in adults, dapagliflozin helps to improve glycemic control by inhibiting glucose reabsorption in the proximal tubule of the nephron and causing glycosuria. Dapagliflozin has been investigated either as monotherapy or as an adjunct treatment with insulin or other oral hypoglycemic agents.

Dapagliflozin was originally approved by the FDA on Jan 08, 2014, to improve glycemic control in adults with type 2 diabetes in conjunction with diet and exercise. It was later approved to reduce the risk of kidney function decline, kidney failure, cardiovascular death, and hospitalization for heart failure in adults with chronic kidney disease in April 2021.

Indication

Dapagliflozin is indicated as an adjunct treatment to improve glycemic control in adult patients with type 2 diabetes mellitus along with diet and exercise.For patients with chronic kidney disease at risk of progression, dapagliflozin in used to reduce the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular death, and

hospitalization for heart failure. Dapagliflozin is also indicated to either reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in adults with heart failure or reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and either established cardiovascular disease or multiple cardiovascular risk factors. Combination products with dapagliflozin also exist, either as a dapagliflozin-saxagliptin or dapagliflozin-metformin hydrochloride formulation. Both are used as an adjunct treatment to diet and exercise to improve glycemic control in adults with type 2 diabetes.

Associated Conditions
Cardiovascular Mortality, End Stage Renal Disease (ESRD), Hospitalizations, Type 2 Diabetes Mellitus, Decreased estimated glomerular filtration rate, Hospitalization due to cardiac failure

Impact of Dapagliflozin on Intestinal Microbiota Composition and on the Metabolites Derived from the Intestinal Microbiota in Non-diabetic Chronic Renal Failure Patients

Not Applicable
Recruiting
Conditions
Chronic Kidney Diseases
Interventions
First Posted Date
2023-07-28
Last Posted Date
2024-12-16
Lead Sponsor
Hospices Civils de Lyon
Target Recruit Count
50
Registration Number
NCT05965440
Locations
🇫🇷

Nephrology department, Hôpital Lyon Sud, Hospices Civils de Lyon, Lyon, France

Short and Intermediate Term Effect of Dapagliflozin on Left Ventricular Remodeling in Anterior STEMI Patients

Phase 3
Recruiting
Conditions
STEMI
Interventions
First Posted Date
2023-07-24
Last Posted Date
2024-04-16
Lead Sponsor
Mohamed Nabil Elkholy
Target Recruit Count
120
Registration Number
NCT05957887
Locations
🇪🇬

Helwan University, Cairo, Egypt

Phase 3 Clinical Trial with Dapagliflozin in Chronic Kidney Disease in Adolescents and Young Adult Patients

Phase 3
Recruiting
Conditions
Chronic Kidney Failure in Children and Young Adults
Interventions
Drug: Placebo
First Posted Date
2023-07-13
Last Posted Date
2024-12-16
Lead Sponsor
University Hospital Goettingen
Target Recruit Count
102
Registration Number
NCT05944016
Locations
🇩🇪

Universitätsklinikum Heidelberg - Children, Heidelberg, Baden-Württenberg, Germany

🇩🇪

LMU Klinikum, München, Bayern, Germany

🇩🇪

v. Haunersches Kinderhospital, München, Bayern, Germany

and more 13 locations

The Efficacy, Mechanism & Safety of Sodium Glucose Co-Transporter-2 Inhibitor & Glucagon-Like Peptide 1 Receptor Agonist Combination Therapy in Kidney Transplant Recipients

Phase 2
Recruiting
Conditions
Kidney Transplant Recipients
Interventions
Drug: Semaglutide, 1.0 mg/mL
First Posted Date
2023-07-10
Last Posted Date
2025-01-31
Lead Sponsor
University Health Network, Toronto
Target Recruit Count
20
Registration Number
NCT05938712
Locations
🇨🇦

Toronto General Hospital, Toronto, Ontario, Canada

Comparison of Dapagliflozin, Lobeglitazone, and Its Combination in Efficacy and Safety

First Posted Date
2023-06-23
Last Posted Date
2023-08-14
Lead Sponsor
Seoul National University Bundang Hospital
Target Recruit Count
99
Registration Number
NCT05915949
Locations
🇰🇷

Seoul National University Bundang Hospital, Seongnam, Gyeonggi, Korea, Republic of

Evaluation of the Safety and Efficacy of SGLT2 Inhibitors in Pre-diabetic Patients

Phase 2
Not yet recruiting
Conditions
Impaired Fasting Glucose
Prediabetic State
Impaired Glucose Tolerance
Interventions
Behavioral: lifestyle interventions
First Posted Date
2023-06-22
Last Posted Date
2023-07-25
Lead Sponsor
Yangjin
Target Recruit Count
120
Registration Number
NCT05914857
Locations
🇨🇳

Peking University Third Hospital, Beijing, Beijing, China

Efficacy and Safety of LID104 in the Treatment of Type II Diabetes Mellitus

Phase 3
Not yet recruiting
Conditions
Type 2 Diabetes Mellitus
Interventions
First Posted Date
2023-06-02
Last Posted Date
2023-06-02
Lead Sponsor
EMS
Target Recruit Count
597
Registration Number
NCT05886088
Locations
🇧🇷

Investigational site, Hortolândia, SP, Brazil

A Study to Investigate the Mechanistic Effects of Dapagliflozin Alone or in Combination With Balcinrenone, Compared to Balcinrenone and Placebo on Body Fluid and Electrolyte Handling and Energy Metabolism in Participants Over 50 Years of Age With Chronic Kidney Disease.

Phase 2
Recruiting
Conditions
Chronic Renal Failure
Mechanistic Effects of SGLT2 Inhibition and/ or MR Antagonism on Body Fluid and Electrolyte Homeostatis
Chronic Kidney Disease Stage 3
Electrolyte and Fluid Balance Conditions
Interventions
Drug: Balcinrenone 50mg Capsule
Drug: Balcinrenone 50mg matching Placebo
Drug: Balcinrenone 100mg Capsule
Drug: Balcinrenone 100mg matching Placebo
First Posted Date
2023-06-01
Last Posted Date
2025-05-07
Lead Sponsor
Klinikum Nürnberg
Target Recruit Count
100
Registration Number
NCT05884866
Locations
🇫🇷

Assistance Publique-Hopitaux de Marseille (AP-HM), Marseille, France

🇩🇪

Klinikum Nuernberg, Nuremberg, Bavaria, Germany

SGLT2 Inhibitor TrEatment iN Patients Awaiting cOronary arTery bYpass Surgery to Reduce Post-opErative AF

Phase 3
Recruiting
Conditions
Chronic Coronary Syndrome
Atrial Fibrillation
Interventions
First Posted Date
2023-05-10
Last Posted Date
2025-04-08
Lead Sponsor
Region Örebro County
Target Recruit Count
800
Registration Number
NCT05852704
Locations
🇩🇰

Department of Cardiothoracic Surgery, Kobenhavn, Copenhagen, Denmark

🇨🇿

St. Anne University Hospital, Brno, Czechia

🇩🇰

Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Aarhus, Denmark, Aarhus, Denmark

and more 5 locations

Effect of Dapagliflozin on Cardiac Structure, Function and Secondary Mitral Regurgitation in Patients with Left Ventricle Dysfunction

First Posted Date
2023-05-09
Last Posted Date
2024-10-16
Lead Sponsor
October 6 University
Target Recruit Count
150
Registration Number
NCT05849766
Locations
🇪🇬

Beni-suef University, Banī Suwayf, Egypt

© Copyright 2025. All Rights Reserved by MedPath