Dapagliflozin

Generic Name: Dapagliflozin

Brand Names: Edistride, Farxiga, Forxiga, Qtern, Qternmet, Xigduo, Dapagliflozin Viatris

Drug Type: Small Molecule

Chemical Formula: C_₂₁H_₂₅ClO_₆

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: -

Clinical Trials

Effect of DapagliFLOzin on Quality of Life in Patients With Type 2 Diabetes in a Real Clinical PrActice

Phase 4

Withdrawn

Conditions: Diabetes Mellitus Type 2

Interventions: Drug: Dapagliflozin
Drug: Metformin

First Posted Date: 2016-03-25

Last Posted Date: 2016-05-20

Lead Sponsor: AstraZeneca

Registration Number: NCT02719132

Effect of Dapagliflozin on Insulin Secretion and Insulin Sensitivity in Patients With Prediabetes

Phase 4

Completed

Conditions: Prediabetes
Impaired Glucose Tolerance
Impaired Fasting Glucose

Interventions: Drug: Dapagliflozin
Drug: Placebo

First Posted Date: 2016-03-07

Last Posted Date: 2020-10-28

Lead Sponsor: University of Guadalajara

Target Recruit Count: 24

Registration Number: NCT02700334

Locations: 🇲🇽
Intstituto de Terapeútica Experimental y Clínica. Centro Universitario de Ciencias de la Salud. Universidad de Guadalajara, Guadalajara, Jalisco, Mexico

The PRE-D Trial: Effect of Dapagliflozin, Metformin and Physical Activity in Pre-diabetes

Phase 2

Completed

Conditions: Prediabetic State
Obesity

Interventions: Drug: Dapagliflozin
Drug: Metformin
Behavioral: Exercise

First Posted Date: 2016-03-01

Last Posted Date: 2019-10-07

Lead Sponsor: Steno Diabetes Center Copenhagen

Target Recruit Count: 120

Registration Number: NCT02695810

Locations: 🇩🇰
Steno Diabetes Center A/S, Gentofte, Denmark

A Multi-Center, Randomized, Double-Blind, Phase III Trial to Evaluate the Safety and Efficacy of Saxagliptin Co-administered With Dapagliflozin Compared to Saxagliptin or Dapagliflozin All Given as add-on Therapy to Metformin in Subject With Type 2 Diabetes

Phase 3

Completed

Conditions: Type 2 Diabetes Mellitus
Inadequate Glycaemic Control

Interventions: Drug: Dapagliflozin
Drug: Placebo for Dapagliflozin
Drug: Placebo for Saxagliptin
Drug: Saxagliptin

First Posted Date: 2016-02-12

Last Posted Date: 2018-10-10

Lead Sponsor: AstraZeneca

Target Recruit Count: 905

Registration Number: NCT02681094

Locations: 🇷🇺
Research Site, Vladikavkaz, Russian Federation

Dapagliflozin Effect on Symptoms and Biomarkers in Patients With Heart Failure

Phase 4

Completed

Conditions: Chronic Heart Failure With Reduced Systolic Function

Interventions: Drug: Dapagliflozin
Drug: Dapagliflozin matching placebo

First Posted Date: 2016-01-12

Last Posted Date: 2022-04-21

Lead Sponsor: Saint Luke's Health System

Target Recruit Count: 263

Registration Number: NCT02653482

Locations: 🇺🇸
University of Southern Califiornia, Los Angeles, California, United States
🇺🇸
Heart Group of the Eastern Shore, Fairhope, Alabama, United States
🇺🇸
NorthShore University HealthSystem Research Institute, Evanston, Illinois, United States

and more 22 locations

A Pragmatic Randomized Trial to Evaluate the Comparative Effectiveness Between Dapagliflozin and Standard of Care in Type 2 Diabetes Patients

Phase 4

Active, not recruiting

Conditions: Type 2 Diabetes Mellitus

Interventions: Drug: Standard of Care
Drug: Dapagliflozin

First Posted Date: 2015-11-30

Last Posted Date: 2024-12-16

Lead Sponsor: University of Liverpool

Target Recruit Count: 632

Registration Number: NCT02616666

Locations: 🇬🇧
Research Site, Wembley, United Kingdom
🇬🇧
Research Site, Alum Rock, Birmingham, United Kingdom
🇬🇧
Research Site, Market Square, Kineton, United Kingdom