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
-

Does Dapagliflozin Regress Left Ventricular Hypertrophy In Patients With Type 2 Diabetes?

First Posted Date
2016-11-06
Last Posted Date
2019-07-09
Lead Sponsor
University of Dundee
Target Recruit Count
66
Registration Number
NCT02956811
Locations
🇬🇧

Ninewells Hospital, Dundee, United Kingdom

Effect of Anti-diabetic Drugs on Glycemic Variability

First Posted Date
2016-10-06
Last Posted Date
2020-03-04
Lead Sponsor
Centro de Diabetes Curitiba Ltda
Target Recruit Count
135
Registration Number
NCT02925559
Locations
🇧🇷

Centro de Diabetes Curitiba, Curitiba, Parana, Brazil

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

First Posted Date
2016-09-22
Last Posted Date
2023-11-30
Lead Sponsor
The University of Texas Health Science Center at San Antonio
Target Recruit Count
72
Registration Number
NCT02911792
Locations
🇺🇸

University Health Systems Texas Diabetic Institute, San Antonio, Texas, United States

🇺🇸

The University of Texas Health Science Center at San Antonio, San Antonio, Texas, United States

Effects of Dapagliflozin on Central Hemodynamics and Urine Albumin Excretion in Patients With Type 2 Diabetes.

Phase 4
Terminated
Conditions
Interventions
First Posted Date
2016-09-02
Last Posted Date
2019-12-03
Lead Sponsor
Hellenic Society for Medical Education
Target Recruit Count
85
Registration Number
NCT02887677
Locations
🇬🇷

Ahepa Hospital, Thessaloniki, Greece

🇬🇷

Hippokrateio Hospital, Thessaloniki, Greece

🇬🇷

Papageorgiou Hospital, Thessaloniki, Greece

HbA1c Variability in Type II Diabetes

First Posted Date
2016-08-25
Last Posted Date
2023-12-14
Lead Sponsor
Weill Cornell Medical College in Qatar
Target Recruit Count
150
Registration Number
NCT02879409
Locations
🇶🇦

Hamad Medical Corporation, Doha, Qatar

Evaluation of the Tubular Effects of Dapagliflozin Using 1HNMR Spectroscopy

Phase 4
Completed
Conditions
Interventions
First Posted Date
2016-06-14
Last Posted Date
2019-04-19
Lead Sponsor
University of Ioannina
Target Recruit Count
50
Registration Number
NCT02798757
Locations
🇬🇷

University of Ioannina, Ioánnina, Greece

Inhibition of Urinary Angiotensinogen and the Reduction of Blood Pressure by SGLT2 Inhibition in Patients With Type 2 Diabetes

First Posted Date
2016-06-10
Last Posted Date
2022-11-01
Lead Sponsor
Tulane University School of Medicine
Target Recruit Count
11
Registration Number
NCT02796170
Locations
🇺🇸

Tulane University, New Orleans, Louisiana, United States

A Single-dose Cross-over Study to Assess Direct and Indirect Effects of Dapagliflozin on Pancreatic Alpha and Beta Cells in Patients With Type 2 Diabetes

First Posted Date
2016-05-06
Last Posted Date
2016-12-12
Lead Sponsor
Uppsala University
Target Recruit Count
15
Registration Number
NCT02765204
Locations
🇸🇪

Dept of Medical Sciences Uppsala University Hospital, Uppsala, Sweden

Study to Evaluate Safety and Efficacy of Dapagliflozin in Patients With Type 2 Diabetes Mellitus Aged 10-24 Years

First Posted Date
2016-04-01
Last Posted Date
2022-02-23
Lead Sponsor
AstraZeneca
Target Recruit Count
72
Registration Number
NCT02725593
Locations
🇬🇧

Research Site, Leicester, United Kingdom

Effect of SGLT-2 Inhibitor Dapagliflozin on Glycemic Variability in Patients With Diabetes Mellitus Type 2

First Posted Date
2016-03-25
Last Posted Date
2016-03-25
Lead Sponsor
Research Clinical Centre of the Russian Railways, JSC
Target Recruit Count
100
Registration Number
NCT02719756
Locations
🇷🇺

Research Clinical Centre of the Russian Railways, JSC, Moscow, Russian Federation

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