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
Associated Therapies
-

Semaglutide and Dapagliflozin in Diabetic Patients With Different Pathophysiology

Phase 2
Active, not recruiting
Conditions
Type2 Diabetes
Interventions
First Posted Date
2020-06-30
Last Posted Date
2022-10-21
Lead Sponsor
Region Skane
Target Recruit Count
200
Registration Number
NCT04451837
Locations
🇸🇪

Anders Rosengrentest, Malmö, Skane, Sweden

mulTi-Arm Therapeutic Study in Pre-ICu Patients Admitted With Covid-19 - Experimental Drugs and Mechanisms

Phase 2
Completed
Conditions
COVID-19
Interventions
Other: Standard of care
Drug: EDP1815
Drug: Dapagliflozin
Drug: Ambrisentan
First Posted Date
2020-05-19
Last Posted Date
2023-07-28
Lead Sponsor
Cambridge University Hospitals NHS Foundation Trust
Target Recruit Count
454
Registration Number
NCT04393246
Locations
🇬🇧

Cambridge University Hospitals NHS Foundation Trust, Cambridge, Cambridgeshire, United Kingdom

Dapagliflozin in Diabetic Patients (Type 2) With Decompensated Heart Failure

Phase 4
Completed
Conditions
Heart Failure
Interventions
Drug: insulin
Drug: Dapagliflozin
First Posted Date
2020-05-13
Last Posted Date
2022-02-16
Lead Sponsor
Assiut University
Target Recruit Count
100
Registration Number
NCT04385589
Locations
🇪🇬

Assiut University, Assuan, Egypt

Dapagliflozin and Effect on Cardiovascular Events in Acute Heart Failure -Thrombolysis in Myocardial Infarction 68 (DAPA ACT HF-TIMI 68)

Phase 4
Recruiting
Conditions
Acute Heart Failure
Heart Failure
Interventions
Drug: Placebo
Drug: Dapagliflozin
First Posted Date
2020-04-27
Last Posted Date
2023-03-31
Lead Sponsor
The TIMI Study Group
Target Recruit Count
2400
Registration Number
NCT04363697
Locations
🇺🇸

TIMI Study Group, Boston, Massachusetts, United States

Comparative Effectiveness of Dapagliflozin Versus DPP-4 Inhibitors

Completed
Conditions
Type 2 Diabetes
Interventions
Drug: DPP-4 inhibitor
Drug: Dapagliflozin
First Posted Date
2020-03-11
Last Posted Date
2020-03-11
Lead Sponsor
University of Padova
Target Recruit Count
11206
Registration Number
NCT04304430
Locations
🇮🇹

University Hospital of Padova, Padova, Italy

DAPAgliflozin Sodium Water glucosE EffecTs in Patients at High Cardiovascular Risk

Phase 2
Recruiting
Conditions
Cardiovascular Risk Factor
Interventions
Drug: Dapagliflozin 10 MG
Drug: Placebo oral tablet
First Posted Date
2020-02-06
Last Posted Date
2023-05-17
Lead Sponsor
University Health Network, Toronto
Target Recruit Count
50
Registration Number
NCT04258371
Locations
🇨🇦

Renal Physiology Laboratory, Toronto, Canada

Dapagliflozin at Discharge on Hospital Heart Failure Readmission

Phase 4
Completed
Conditions
Diabetes
Heart Failure
Interventions
Drug: Placebo
Drug: Dapagliflozin
First Posted Date
2020-01-31
Last Posted Date
2024-06-14
Lead Sponsor
Emory University
Target Recruit Count
105
Registration Number
NCT04249778
Locations
🇺🇸

Temple University, Philadelphia, Pennsylvania, United States

🇺🇸

Tulane University, New Orleans, Louisiana, United States

🇺🇸

Emory University Hospital, Atlanta, Georgia, United States

Study to Explore the Effect of Dapagliflozin and Stress in Adolescent and Adult Subjects With Type 1 Diabetes (T1D)

Phase 1
Terminated
Conditions
Type 1 Diabetes
Diabetic Ketoacidosis
Interventions
Drug: Placebo oral tablet
Drug: Dapagliflozin
Other: Stress
Other: Placebo Stress
First Posted Date
2020-01-21
Last Posted Date
2024-12-09
Lead Sponsor
Kinderkrankenhaus auf der Bult
Target Recruit Count
2
Registration Number
NCT04234867
Locations
🇩🇪

Kinder- und Jugendkrankenhaus AUF DER BULT, Hanover, Lower Saxony, Germany

Replication of the DECLARE Diabetes Trial in Healthcare Claims

Completed
Conditions
Diabetes
Interventions
Drug: DPP-4 inhibitor
Drug: Dapagliflozin
First Posted Date
2020-01-02
Last Posted Date
2023-07-27
Lead Sponsor
Brigham and Women's Hospital
Target Recruit Count
49790
Registration Number
NCT04215523
Locations
🇺🇸

Brigham & Women's Hospital, Boston, Massachusetts, United States

Dapagliflozin Efficacy and Action in PCOS

Phase 3
Completed
Conditions
Polycystic Ovary Syndrome
Interventions
Drug: Placebo
Drug: Dapagliflozin
First Posted Date
2019-12-30
Last Posted Date
2023-01-12
Lead Sponsor
Nanfang Hospital, Southern Medical University
Target Recruit Count
165
Registration Number
NCT04213677
Locations
🇨🇳

Nanfang Hospital of Southern Medical University, Guangzhou, Guangdong, China

© Copyright 2025. All Rights Reserved by MedPath