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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
-

Does Dapagliflozin Promote Favorable Health Benefits That Are Independent Of Weight Loss?

Phase 2
Terminated
Conditions
Weight Loss
Interventions
Drug: Dapagliflozin
Drug: Placebo
Behavioral: Ad libitum dietary intake
Behavioral: Weight maintenance
Behavioral: Dietary restriction
First Posted Date
2015-08-13
Last Posted Date
2019-01-03
Lead Sponsor
Christopher Bell
Target Recruit Count
9
Registration Number
NCT02520518
Locations
🇺🇸

Colorado State University, Dept. of Health and Exercise Science, Fort Collins, Colorado, United States

Dapagliflozin As Additional Treatment To Liraglutide And Insulin In Patients With Type 1 Diabetes

Phase 3
Completed
Conditions
Type 1 Diabetes Mellitus
Interventions
First Posted Date
2015-08-10
Last Posted Date
2024-01-24
Lead Sponsor
University at Buffalo
Target Recruit Count
26
Registration Number
NCT02518945
Locations
🇺🇸

ECMC Ambulatory Center, 3rd Floor, Buffalo, New York, United States

Effect of Dapagliflozine on Systemic and Renal Endothelial Function

Phase 4
Conditions
Endothelial Function
Type 2 Diabetes
Interventions
First Posted Date
2015-07-17
Last Posted Date
2015-07-17
Lead Sponsor
Seoul National University Hospital
Target Recruit Count
22
Registration Number
NCT02501616
Locations
🇰🇷

Boramae medical center, Seoul, Korea, Republic of

Vildagliptin Versus Dapagliflozin on Glucagon

Phase 4
Completed
Conditions
Type 2 Diabetes
Interventions
First Posted Date
2015-06-18
Last Posted Date
2019-05-02
Lead Sponsor
Lund University
Target Recruit Count
28
Registration Number
NCT02475070
Locations
🇸🇪

Lund University, Lund, Sweden

Efficacy and Safety of Dapagliflozin and Dapagliflozin Plus Saxagliptin in Combination With Metformin in Type 2 Diabetes Patients Compared With Sulphonylurea

First Posted Date
2015-06-15
Last Posted Date
2019-03-26
Lead Sponsor
AstraZeneca
Target Recruit Count
939
Registration Number
NCT02471404
Locations
🇸🇰

Research Site, Vrutky, Slovakia

Dapagliflozin Evaluation in Patients With Inadequately Controlled Type 1 Diabetes

Phase 3
Completed
Conditions
Type 1 Diabetes Mellitus
Interventions
Drug: Dapagliflozin
Other: Placebo for dapagliflozin
First Posted Date
2015-06-03
Last Posted Date
2019-03-05
Lead Sponsor
AstraZeneca
Target Recruit Count
815
Registration Number
NCT02460978
Locations
🇬🇧

Research Site, Wakefield, United Kingdom

Effect of Dapagliflozin on Glycemic Variability

Phase 4
Completed
Conditions
Type 2 Diabetes Mellitus
Interventions
Drug: Placebo
Drug: Dapagliflozin
First Posted Date
2015-06-02
Last Posted Date
2017-07-13
Lead Sponsor
The Catholic University of Korea
Target Recruit Count
86
Registration Number
NCT02459353
Locations
🇰🇷

Seoul St.Mary's Hospital, Seoul, Korea, Republic of

An Investigation Into The Anti-hypertensive And Potential Anti-inflammatory Actions Of Dapagliflozin

Phase 4
Completed
Conditions
Type 2 Diabetes
Interventions
Drug: Placebo
Drug: dapagliflozin
First Posted Date
2015-05-05
Last Posted Date
2019-10-30
Lead Sponsor
University at Buffalo
Target Recruit Count
52
Registration Number
NCT02433678
Locations
🇺🇸

ECMC Ambulatory Center, 3rd Floor, Buffalo, New York, United States

Effect of Dapagliflozin on 24-hour Blood Glucose in T2DM Patients Inadequately Controlled With Either Metformin Or Insulin

Phase 4
Completed
Conditions
Type II Diabetes
Interventions
Drug: Placebo
Drug: Farxiga
Drug: Metformin
Drug: Insulin
First Posted Date
2015-04-29
Last Posted Date
2017-06-14
Lead Sponsor
AstraZeneca
Target Recruit Count
226
Registration Number
NCT02429258
Locations
🇺🇸

Research Site, Renton, Washington, United States

Effects of Dapagliflozin 10 mg on Insulin Resistance in Patients With Type 2 Diabetes Mellitus

Phase 4
Completed
Conditions
Type 2 Diabetes Mellitus
Interventions
Drug: Placebo
Drug: Dapagliflozin
First Posted Date
2015-04-27
Last Posted Date
2018-02-05
Lead Sponsor
AstraZeneca
Target Recruit Count
55
Registration Number
NCT02426541
Locations
🇫🇮

Research Site, Turku, Finland

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