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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

A Prospective Trial of Enavogliflozin to Evaluate Cardio-renal Outcome in Type 2 Diabetes Mellitus Patients

Phase 4
Recruiting
Conditions
Diabetes Mellitus, Type 2
Cardiovascular Diseases
Kidney Diseases
Interventions
First Posted Date
2024-10-15
Last Posted Date
2024-10-15
Lead Sponsor
Yonsei University
Target Recruit Count
2862
Registration Number
NCT06642623
Locations
🇰🇷

Department of Internal Medicine, Yonsei University College of Medicine, 50-1 Yonsei-ro, Seodaemun-gu, Seoul 03722, Republic of Korea, Seoul, Korea, Republic of

A Pragmatic Trial Comparing Empagliflozin and Dapagliflozin Through Cluster Randomization Embedded in the Electronic Health Record

Phase 4
Recruiting
Conditions
Diabetes Mellitus, Type 2
Heart Failure
Chronic Kidney Diseases
Interventions
First Posted Date
2024-10-15
Last Posted Date
2024-11-05
Lead Sponsor
Herlev and Gentofte Hospital
Target Recruit Count
17200
Registration Number
NCT06642272
Locations
🇩🇰

Bispebjerg Hospital, Copenhagen, Denmark

🇩🇰

Rigshospitalet, Copenhagen, Denmark

🇩🇰

Steno Diabetes Center Copenhagen, Herlev, Denmark

and more 8 locations

Dapagliflozin in Allo-HCT for AGVHD

Phase 2
Not yet recruiting
Conditions
Graft-versus-host Disease (GVHD)
Interventions
First Posted Date
2024-10-04
Last Posted Date
2024-10-04
Lead Sponsor
The First Affiliated Hospital of Soochow University
Target Recruit Count
97
Registration Number
NCT06626737
Locations
🇨🇳

The First Affiliated Hospital of Soochow University, Suzhou, Jiangsu, China

Effect of Dapagliflozin in Myocardial Fibrosis and Ventricular Function in Patients with a ST-segment Elevation Myocardial Infarction

Phase 3
Active, not recruiting
Conditions
ST-segment Elevation Myocardial Infarction (STEMI)
Diabetes Mellitus
Myocardial Fibrosis
Heart Failure
Interventions
Drug: Placebo
First Posted Date
2024-10-01
Last Posted Date
2025-02-19
Lead Sponsor
Hospital Clinic of Barcelona
Target Recruit Count
54
Registration Number
NCT06619600
Locations
🇪🇸

Hospital de la Santa Creu i Sant Pau, Barcelona, Catalonia, Spain

🇪🇸

Hospital Clinic of Barcelona, Barcelona, Catalonia, Spain

Effect of Dapagliflozin Administration on the Apoptosis Levels of Patients with Acute Myocardial Infarction

Phase 4
Completed
Conditions
Acute Myocardial Infarction (AMI)
STEMI - ST Elevation Myocardial Infarction (MI)
NSTEMI - Non-ST Segment Elevation Myocardial Infarction (MI)
Interventions
First Posted Date
2024-09-26
Last Posted Date
2025-02-27
Lead Sponsor
Yoga Yudhistira
Target Recruit Count
40
Registration Number
NCT06615674
Locations
🇮🇩

Dr. Moewardi General Hospital, Jebres, Surakarta, Central of Java, 57126, Surakarta, Central of Java, Indonesia

Dapagliflozin in Mangement of Pulmonary Hypertension Patients

Phase 1
Not yet recruiting
Conditions
Pulmonary Hypertension
Interventions
First Posted Date
2024-09-25
Last Posted Date
2024-10-29
Lead Sponsor
Assiut University
Target Recruit Count
70
Registration Number
NCT06612086
Locations
🇪🇬

Assiut university, Assuit, Egypt

A Study of Dapagliflozin in Chinese Adult Patients With Chronic Kidney Disease

Phase 4
Recruiting
Conditions
Chronic Kidney Disease
Interventions
First Posted Date
2024-09-24
Last Posted Date
2025-05-09
Lead Sponsor
AstraZeneca
Target Recruit Count
700
Registration Number
NCT06610526
Locations
🇨🇳

Research Site, Xian, China

A Study of HRS-7535 Compared With Dapagliflozin in Adult Participants With Type 2 Diabetes and Inadequately Controlled With Metformin

Phase 3
Recruiting
Conditions
Type 2 Diabetes
Interventions
Drug: HRS-7535 tablet
First Posted Date
2024-09-19
Last Posted Date
2025-01-09
Lead Sponsor
Shandong Suncadia Medicine Co., Ltd.
Target Recruit Count
800
Registration Number
NCT06589765
Locations
🇨🇳

Beijing Hospital, Beijing, Beijing, China

Study Targeting Myocardial Perfusion and Symptom Relief in Women with SGLT2 Inhibitors (STRONG)

Phase 1
Not yet recruiting
Conditions
Angina Patients with Non-obstructive Coronary Artery Disease
Coronary Microvascular Disease
Coronary Microvascular Dysfunction (CMD)
Interventions
First Posted Date
2024-09-19
Last Posted Date
2025-03-27
Lead Sponsor
University of Virginia
Target Recruit Count
150
Registration Number
NCT06600178
Locations
🇺🇸

UVA Health, Charlottesville, Virginia, United States

Effect of the Use of Dapagliflozin in Patients With Refractory Heart Failure

Phase 4
Recruiting
Conditions
Heart Failure
Interventions
First Posted Date
2024-08-29
Last Posted Date
2025-03-11
Lead Sponsor
Fundación para la Investigación del Hospital Clínico de Valencia
Target Recruit Count
31
Registration Number
NCT06578520
Locations
🇪🇸

Hospital Clínico Universitario de Valencia, Valencia, Spain

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