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
- -
Treating to Reduce Albuminuria and Normalize Hemodynamic Function in Focal ScLerosis With dApagliflozin Trial Effects
- First Posted Date
- 2015-10-23
- Last Posted Date
- 2018-01-16
- Lead Sponsor
- University Health Network, Toronto
- Target Recruit Count
- 10
- Registration Number
- NCT02585804
- Locations
- 🇨🇦
Renal Physiology Laboratory, University Health Network, Toronto, Ontario, Canada
Dapagliflozin on Hyperlipidemia and Insulin Resistance in Type 2 Diabetic Patients (DAPHNIS Study)
- First Posted Date
- 2015-10-16
- Last Posted Date
- 2018-08-29
- Lead Sponsor
- Osaka University
- Target Recruit Count
- 50
- Registration Number
- NCT02577159
- Locations
- 🇯🇵
Sousei Hospital, Kadoma, Osaka, Japan
🇯🇵Osaka University Hospital, Suita, Osaka, Japan
🇯🇵Osaka Central Hospital, Osaka city, Osaka, Japan
Foxiga Korea Local Phase 4 Study
- Conditions
- Interventions
- First Posted Date
- 2015-10-01
- Last Posted Date
- 2019-08-20
- Lead Sponsor
- AstraZeneca
- Target Recruit Count
- 125
- Registration Number
- NCT02564926
- Locations
- 🇰🇷
Research Site, Wonju-si, Korea, Republic of
Effects of SGLT-2 Inhibition on Hepatic Glucose and Energy Metabolism
- Conditions
- Interventions
- First Posted Date
- 2015-09-23
- Last Posted Date
- 2016-09-27
- Lead Sponsor
- Medical University of Vienna
- Target Recruit Count
- 20
- Registration Number
- NCT02558270
- Locations
- 🇦🇹
Medical University Of Vienna, Department of Internal Medicine III, Vienna, Austria
A Study to Assess the Addition of Sitagliptin to Metformin Compared With the Addition of Dapagliflozin to Metformin in Participants With Type 2 Diabetes Mellitus (T2DM) and Mild Renal Impairment Who Have Inadequate Glycemic Control on Metformin With or Without a Sulfonylurea (MK-0431-838)
- First Posted Date
- 2015-08-26
- Last Posted Date
- 2018-11-20
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Target Recruit Count
- 614
- Registration Number
- NCT02532855
Does Dapagliflozin Promote Favorable Health Benefits That Are Independent Of Weight Loss?
- Conditions
- Interventions
- 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
- Conditions
- 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
- 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
- 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
Drug Development Updates
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