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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
-

Effects of Single Oral Dose Dapagliflozin QT Study

First Posted Date
2008-06-03
Last Posted Date
2012-03-21
Lead Sponsor
AstraZeneca
Target Recruit Count
36
Registration Number
NCT00688493
Locations
🇺🇸

Research Site, Baltimore, Maryland, United States

Add-on to Thiazolidinedione (TZD) Failures

First Posted Date
2008-05-26
Last Posted Date
2017-02-23
Lead Sponsor
AstraZeneca
Target Recruit Count
972
Registration Number
NCT00683878
Locations
🇺🇸

Diabetes Research Center, Tustin, California, United States

🇺🇸

Endocrine Research Associates, Jackson, Mississippi, United States

🇺🇸

Dallas Diabetes & Endocrine Center, Dallas, Texas, United States

and more 55 locations

Efficacy and Safety of Dapagliflozin in Combination With Glimepiride (a Sulphonylurea) in Type 2 Diabetes Patients

First Posted Date
2008-05-20
Last Posted Date
2013-10-14
Lead Sponsor
AstraZeneca
Target Recruit Count
597
Registration Number
NCT00680745
Locations
🇺🇦

Research Site, Zaporozhye, Ukraine

Efficacy and Safety of Dapagliflozin, Added to Therapy of Patients With Type 2 Diabetes With Inadequate Glycemic Control on Insulin

Phase 3
Completed
Conditions
Type 2 Diabetes
Interventions
Drug: Dapagliflozin
Drug: Placebo
First Posted Date
2008-05-07
Last Posted Date
2013-10-29
Lead Sponsor
AstraZeneca
Target Recruit Count
1240
Registration Number
NCT00673231
Locations
🇬🇧

Research Site, Swansea, United Kingdom

Glycemic Efficacy and Renal Safety Study of Dapagliflozin in Subjects With Type 2 Diabetes Mellitus and Moderate Renal Impairment

Phase 2
Completed
Conditions
Diabetes Mellitus, Type 2
Interventions
Drug: Placebo
Drug: Dapagliflozin
First Posted Date
2008-04-22
Last Posted Date
2017-02-10
Lead Sponsor
AstraZeneca
Target Recruit Count
631
Registration Number
NCT00663260
Locations
🇺🇸

Marin Endocrine Care & Research, Inc., Greenbrae, California, United States

🇺🇸

Diabetes Medical Center Of California, Northridge, California, United States

🇺🇸

Office Of Richard Cherlin, Md, Los Gatos, California, United States

and more 32 locations

Efficacy and Safety of Dapagliflozin in Combination With Metformin in Type 2 Diabetes Patients

Phase 3
Completed
Conditions
Type 2 Diabetes
Interventions
First Posted Date
2008-04-17
Last Posted Date
2015-03-30
Lead Sponsor
AstraZeneca
Target Recruit Count
1217
Registration Number
NCT00660907
Locations
🇬🇧

Research Site, Trowbridge, United Kingdom

An Efficacy & Safety Study of BMS-512148 in Combination With Metformin Extended Release Tablets

Phase 3
Completed
Conditions
Type 2 Diabetes
Interventions
First Posted Date
2008-03-26
Last Posted Date
2023-01-30
Lead Sponsor
AstraZeneca
Target Recruit Count
994
Registration Number
NCT00643851
Locations
🇺🇸

Southeastern Research Associates, Inc., Greenville, South Carolina, United States

🇺🇸

Jackson Clinic, Rolling Fork, Mississippi, United States

🇺🇸

Community Health Care, Inc., Canal Fulton, Ohio, United States

and more 42 locations

Pharmacokinetic Drug Interaction Study With Dapagliflozin and Glimepiride in Healthy Subjects

Phase 1
Completed
Conditions
Diabetes Mellitus, Type 2
Interventions
First Posted Date
2007-11-22
Last Posted Date
2016-10-17
Lead Sponsor
AstraZeneca
Target Recruit Count
11
Registration Number
NCT00562250
Locations
🇦🇷

Local Institution, Vicente Lopez, Buenos Aires, Argentina

Renal Impairment in Type 2 Diabetic Subjects

Phase 1
Completed
Conditions
Diabetes Mellitus, Type 2
Interventions
First Posted Date
2007-11-07
Last Posted Date
2016-10-17
Lead Sponsor
AstraZeneca
Target Recruit Count
40
Registration Number
NCT00554450
Locations
🇺🇸

Prism Research, St. Paul, Minnesota, United States

🇺🇸

Advanced Clinical Research Institute, Anaheim, California, United States

🇺🇸

Elite Research Institute, Miami, Florida, United States

and more 1 locations

Drug Interaction With Metformin

Phase 1
Completed
Conditions
Healthy Male and Female Subjects
Interventions
First Posted Date
2007-10-19
Last Posted Date
2016-12-20
Lead Sponsor
AstraZeneca
Target Recruit Count
18
Registration Number
NCT00546741
Locations
🇺🇸

Bristol-Myers Squibb Clinical Pharmacology Unit, Hamilton, New Jersey, United States

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