Clinical trials: Dapagliflozin (Forxiga)
Healthy
Bioequivalence Study of Dapagliflozin 10 mg Film-coated Tablets
The study was an open-label, randomized, single-dose, two-period, two-sequence, two-day crossover study, conducted to find out whether the dapagliflozin 10 mg film-coated tablet produced by PT Dexa Medica (test drug) was…
- Trial name
- NCT06127212
- Testing
- Dapagliflozin 10 mg film-coated tablet, Forxiga® 10 mg Film-Coated Tablet, manufactured by AstraZeneca Pharmaceuticals LP, USA for AstraZeneca Pharmaceuticals Co. Ltd., China imported by PT AstraZeneca Indonesia, Indonesia
- Where
- Indonesia
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Dexa Medica Group
SGLT 2 Inhibitors, Pediatric Kidney Disease
Efficacy and Safety of Dapagliflozin in Children With Proteinuria
This interventional study investigates the efficacy of dapagliflozin, a sodium-glucose co-transporter 2 (SGLT2) inhibitor, in pediatric patients with renal disease.
- Conditions
- SGLT 2 Inhibitors, Pediatric Kidney Disease, Proteinuric Diseases, Dapagliflozin (Forxiga)
- Trial name
- NCT07204743
- Testing
- Dapagliflozin (5-10 mg daily) - SGLT2 Inhibitor Therapy
- Where
- Palestinian Territories
- Volunteers
- 10 people
- Sponsor
- Al-Quds University
Type 2 Diabetes Mellitus
A Pragmatic Randomized Trial to Evaluate the Comparative Effectiveness Between Dapagliflozin and Standard of Care in Type 2 Diabetes Patients
A trial of patients with type 2 diabetes mellitus to evaluate the comparative effectiveness between dapagliflozin and Standard of Care (SOC)
- Trial name
- DECIDE (NCT02616666)
- Testing
- Dapagliflozin, Standard of Care
- Where
- 132 sites in United Kingdom
- Volunteers
- 632 people
- Sponsor
- University of Liverpool
Glioma, Dapagliflozin (Forxiga)
Dapagliflozin Versus Dexamethasone Role in Pre-operative Management of Non- Diabetic Brain Tumor Patients
The aim of the study is to compare between the role of dapagliflozin versus dexamethasone in pre-operative management of non-diabetic glioma patients on levetiracetam as anti-seizure drug.
- Conditions
- Glioma, Dapagliflozin (Forxiga), Dexamethasone
- Trial name
- NCT06750458
- Testing
- DexamethasoneGroup III (n=25) (Dexamethasone group)
- Where
- Egypt
- Volunteers
- 75 people
- Sponsor
- Tanta University
Healthy Volunteer
A Study to Assess the Bioequivalence of Fixed Dose Combination of Dapagliflozin/Metformin XR Relative to Co-administration of the Individual Components in Healthy Chinese Subjects.
To assess the bioequivalence between dapagliflozin/metformin XR FDC tablet and co-administration of dapagliflozin and metformin XR tablets.
- Trial name
- NCT04856007
- Testing
- Dapagliflozin/metformin XR FDC 5/500 mg, Dapagliflozin/metformin XR FDC 10/1000 mg, Dapagliflozin 5 mg + Metformin 500 mg XR
- Where
- China
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Safety Outcomes
Safety Of DAPAGLIFLOZIN (FORXIGA) in Patient With Type 2 Diabetes Mellitus (T2dm) In Vietnam From A Post-Marketing Surveillance Program
This study is conducted to meet the requirements of the Drug Administration of Vietnam (DAV) on conducting necessary safety evaluations in routine clinical practice for a new medication within 3 years from its date of approval.
- Trial name
- DAPAPMS (NCT07210307)
- Where
- Vietnam
- Volunteers
- 1,001 people
- Sponsor
- AstraZeneca
Type 2 Diabetes
forREAL: FORXIGA PRESCRIPTION EVENT MONITORING PROGRAM (PEMP)
The study purpose is to assess adverse events in patients with Type 2 diabetes who have newly been prescribed Forxiga for the management of glycemic control
- Trial name
- forREAL (NCT01944618)
- Testing
- Forxiga
- Where
- Australia
- Volunteers
- 5,000 people
- Sponsor
- AstraZeneca
Dapagliflozin (Forxiga), Hyperglycaemia
Dapagliflozin as Prophylaxis for Glucocorticoid-Induced Hyperglycemia
The goal of this clinical trial is to investigate whether dapagliflozin can help prevent glucocorticoid-induced hyperglycemia (GIH) in hospitalized patients requiring high-dose glucocorticoids (GCs).
- Conditions
- Dapagliflozin (Forxiga), Hyperglycaemia, Glucocorticoid
- Trial name
- DAPACOID (NCT06748105)
- Testing
- Dapagliflozin (DAPA)
- Where
- Mexico
- Volunteers
- 38 people
- Sponsor
- Lauro Fabián Amador Medina
Healthy
A Study to Compare the Pharmacodynamics of Canagliflozin and Dapagliflozin in Healthy Volunteers
The purpose of this study is to compare the pharmacodynamics (ie, how the drug affects the body) of canagliflozin with the pharmacodynamics of dapagliflozin.
- Trial name
- NCT01877889
- Testing
- Canagliflozin, Dapagliflozin
- Where
- Germany
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Janssen-Cilag International NV
Diabetic Macular Edema, Center-involved Diabetic Macular Edema
Randomized Clinical Trial to Evaluate the Effect of Dapagliflozin in Patients With Diabetic Macular Edema
The purpose of this clinical study is to explore the efficacy of dapagliflozin as an adjunct to intravitreal anti-vascular endothelial growth factor (anti-VEGF) for enhanced reduction of retinal thickness and vision improvement…
- Trial name
- DAPA-DME (NCT06845163)
- Testing
- Dapagliflozin, Anti-VEGF drug
- Where
- Egypt
- Volunteers
- 56 people
- Sponsor
- Alexandria University
Congenital Heart Disease, Repaired Tetralogy of Fallot (rTOF)
Sodium-Glucose Cotransporter 2 Inhibitors for Repaired Tetralogy of Fallot Patients for Enhancement of Cardio-Pulmonary Status Trial
Repaired Tetralogy of Fallot (rTOF) is the leading cause of congenital cyanotic heart disease worldwide, involving up to 7-10% of congenital heart disease.
- Conditions
- Congenital Heart Disease, Repaired Tetralogy of Fallot (rTOF), Pulmonary Regurgitation, Sodium-glucose Cotransporter 2 (SGLT2) Inhibitor
- Trial name
- STEPS (NCT06668389)
- Testing
- SGLT2 inhibitor (Dapagliflozin 10mg)
- Where
- Hong Kong
- Volunteers
- 106 people
- Sponsor
- The University of Hong Kong
Type 2 Diabetes Mellitus
Forxiga (Dapagliflozin) Regulatory Postmarketing Surveillance
This surveillance is a postmarketing commitment following the marketing authorization for Forxiga(dapagliflozin) in accordance with Standards on Re-examination of New Drugs, notified by the MFDS under Article 32, Paragraph 1 and…
- Trial name
- NCT02252224
- Where
- 6 sites in South Korea
- Volunteers
- 3,123 people
- Sponsor
- AstraZeneca
Dapagliflozin (Forxiga), Atrial Fibrillation (AF)
Dapagliflozin on Outcomes of Rhythm Control Strategy (Pharmacological ± Interventional) in Patient with Atrial Fibrillation
Investigator study the efficacy and safety outcomes of Dapagliflozin use among newly diagnosed Atrial fibrillation patients when underwent rhythm control strategy regardless their diabetic status.
- Trial name
- NCT06759909
- Testing
- Dapagliflozin (DAPA)
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Assiut University
Healthy Subjects
Dapagliflozin Tablet 10 mg Relative to Forxiga® Tablets 10 mg
The study is to compare the rate and extent of absorption of a generic formulation with that of a reference for mulation when given as equal labeled dose.
- Trial name
- DAP-030-23 (NCT06233045)
- Testing
- Dapagliflozin-Test product, Dapagliflozin-Reference product
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Bio-innova Co., Ltd
Diabetes Mellitus, Type 2
An Open-label, Randomized, Crossover Study of Comparative Pharmacokinetics and Bioequivalence of Dapagliflozin + Metformin, 10 mg + 1000 mg Versus the Combined Use of Forxiga™, 10 mg and Two Glucophage® Long, ER Tablets, 500 mg Co-administered to Healthy Volunteers Under Standard Fed Conditions
The aim of this study is to demonstrate bioequivalence of fixed dose combination Dapagliflozin + Metformin modified -release, film-coated tablets, 10 mg + 1000 mg, (AstraZeneca AB, Sweden) versus Forxiga™ (Dapagliflozin)…
- Trial name
- NCT02722239
- Testing
- Xigduo XR, Metformin ER (Glucophage® long), Dapagliflozin (Forxiga)
- Where
- Russia
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Metabolic Syndrome X
Effect of Dapagliflozin Administration on Metabolic Syndrome, Insulin Sensitivity, and Insulin Secretion
The Metabolic Syndrome is a high prevalence disease worldwide. About a quarter of the adult population suffers the disease. Dapagliflozin is an inhibitor of the sodium-glucose co-transporter SGLT2 in the kidney and is a novel…
- Trial name
- NCT02113241
- Testing
- Dapagliflozin
- Where
- Mexico
- Volunteers
- 24 people
- Sponsor
- University of Guadalajara