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
-

A Study to Evaluate the Effect of Dapagliflozin on Renal Outcomes and Cardiovascular Mortality in Patients With Chronic Kidney Disease

Phase 3
Completed
Conditions
Interventions
First Posted Date
2017-01-30
Last Posted Date
2021-07-07
Lead Sponsor
AstraZeneca
Target Recruit Count
4304
Registration Number
NCT03036150
Locations
🇻🇳

Research Site, Hochiminh, Vietnam

Effects of Combined Dapagliflozin and Exenatide Versus Dapagliflozin and Placebo on Ectopic Lipids in Patients With Uncontrolled Type 2 Diabetes Mellitus.

First Posted Date
2017-01-02
Last Posted Date
2022-04-15
Lead Sponsor
Medical University of Vienna
Target Recruit Count
34
Registration Number
NCT03007329
Locations
🇦🇹

Abt. für Endokrinologie & Stoffwechsel, Univ. Klin f. Innere Medizin III, Wien, Austria

Effect of Dapagliflozin on Blood Pressure Variability in Prediabetes and Prehypertension

First Posted Date
2016-12-30
Last Posted Date
2020-11-09
Lead Sponsor
University of Guadalajara
Target Recruit Count
30
Registration Number
NCT03006471
Locations
🇲🇽

Instituto de Terapeútica Experimental y Clínica. Centro Universitario de Ciencias de la Salud. Universidad de Guadalajara, Guadalajara, Jalisco, Mexico

Pilot Study to Explore the Efficacy of DAPAglifozin as add-on to Closed-loop Control in Patients With Type 1 Diabetes

Phase 1
Completed
Conditions
Interventions
First Posted Date
2016-12-09
Last Posted Date
2024-10-11
Lead Sponsor
Kinderkrankenhaus auf der Bult
Target Recruit Count
30
Registration Number
NCT02987738
Locations
🇩🇪

Kinder - und Jugendkrankenhaus AUF DER BULT, Hannover, Germany

Paradoxical Stimulation of Hepatic Glucose Production With Dapagliflozin

Phase 3
Completed
Conditions
Interventions
First Posted Date
2016-12-07
Last Posted Date
2019-12-18
Lead Sponsor
The University of Texas Health Science Center at San Antonio
Target Recruit Count
30
Registration Number
NCT02984644
Locations
🇺🇸

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

Effect of Dapagliflozin on Hepatic and Renal Glucose Metabolism Subjects

Phase 4
Completed
Conditions
Interventions
First Posted Date
2016-12-05
Last Posted Date
2024-03-04
Lead Sponsor
The University of Texas Health Science Center at San Antonio
Target Recruit Count
32
Registration Number
NCT02981966
Locations
🇺🇸

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

Effect of Chronic Exenatide Therapy on Beta Cell Function and Insulin Sensitivity in T2DM

First Posted Date
2016-12-02
Last Posted Date
2023-07-20
Lead Sponsor
The University of Texas Health Science Center at San Antonio
Target Recruit Count
90
Registration Number
NCT02981069
Locations
🇺🇸

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

Dapagliflozin and Measures of Cardiovascular Autonomic Function in Patients With Type 2 Diabetes (T2D)

First Posted Date
2016-11-25
Last Posted Date
2020-10-22
Lead Sponsor
University of Michigan
Target Recruit Count
45
Registration Number
NCT02973477
Locations
🇺🇸

University of Michigan, Ann Arbor, Michigan, United States

Pre-diabetes in Subject With Impaired Fasting Glucose (IFG) and Impaired Glucose Tolerance (IGT)

First Posted Date
2016-11-21
Last Posted Date
2024-08-07
Lead Sponsor
The University of Texas Health Science Center at San Antonio
Target Recruit Count
700
Registration Number
NCT02969798
Locations
🇺🇸

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

An Investigation Into the Effect of Dapagliflozin on Ketogenesis in Type 1 Diabetes

First Posted Date
2016-11-11
Last Posted Date
2024-02-29
Lead Sponsor
University at Buffalo
Target Recruit Count
70
Registration Number
NCT02962492
Locations
🇺🇸

Diabetes and Endocrinology Research Center of WNY, Williamsville, New York, United States

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