Clinical trials: Dapagliflozin
Chronic Kidney Disease
A Study to Evaluate the Safety and Efficacy of AZD5718 in Participants With Proteinuric Chronic Kidney Disease
The purpose of the study is to evaluate the dose-response efficacy, safety, and pharmacokinetics (PK) of AZD5718 in participants with proteinuric chronic kidney disease.
- Trial name
- NCT04492722
- Testing
- AZD5718, Dapagliflozin 10 mg
- Where
- 111 sites in United States, Argentina and 9 more
- Volunteers
- 613 people
- Sponsor
- AstraZeneca
Type 2 Diabetes Mellitus
Study of the Effect of Dapagliflozin on the Pharmacokinetics of Warfarin or Digoxin in Healthy Subjects
The purpose of this study is determine that Dapagliflozin has no effect on the pharmacokinetics (PK) or pharmacodynamics (PD) of warfarin when dapagliflozin is coadministered with warfarin.
- Trial name
- NCT00904176
- Testing
- Dapagliflozin, Warfarin, Digoxin
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Diabetes Mellitus, Type 2
Pharmacokinetic Drug Interaction Study With Dapagliflozin and Glimepiride in Healthy Subjects
The purpose of the study is to determine the effect of glimepiride on dapagliflozin and the effect of dapagliflozin on glimepiride in healthy volunteers.
- Trial name
- NCT00562250
- Testing
- Dapagliflozin, Glimepiride, Dapagliflozin + Glimepiride
- Where
- Argentina
- Volunteers
- 11 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Type2 Diabetes Mellitus
Efficacy and Safety of Lima Association in the Control of Type II Diabetes Mellitus.
The purpose of this study is to evaluate the efficacy and safety of Lima association in the control of type 2 diabetes mellitus
- Trial name
- NCT03766750
- Testing
- LIMA association, Tradjenta, Forxiga
- Sponsor
- EMS
Healthy Subjects in Fasted and Fed State
The Purpose of the Study is to Compare Two Fixed Dose Combination Tablets of Dapagliflozin/Metformin XR in Healthy Subjects Under Fasting and Fed Conditions
This is a bioequivalence study of two doses of the dapagliflozin/metformin XR tablet manufactured at two different plants.
- Trial name
- NCT03216278
- Testing
- Dapagliflozin/metformin XR 5/500mg, Dapagliflozin/metformin XR 5/500 mg, Dapagliflozin/metformin XR 10/1000mg
- Where
- Brazil
- Volunteers
- 284 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Type 2 Diabetes Mellitus
Drug-drug Interaction Study of Dapagliflozin With Voglibose in Japanese Type 2 Diabetes Mellitus Patients
The purpose of this study is to evaluate the pharmacokinetics of dapagliflozin when administered alone or in combination with voglibose in Japanese patients with type 2 diabetes by assessment of AUC and Cmax of dapagliflozin
- Trial name
- NCT01055652
- Testing
- Dapagliflozin
- Where
- 2 sites in Japan
- Volunteers
- 28 people
- Sponsor
- AstraZeneca
Healthy
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of DWP16001 After Oral Administration in Healthy Male Volunteers
This is a dose block-randomized, double-blind, placebo- and active-controlled, single and multiple dosing, dose-escalation clinical phase 1 trial to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of…
- Trial name
- NCT03364985
- Testing
- DWP16001, Dapagliflozin
- Where
- South Korea
- Volunteers
- 123 people, healthy volunteers welcome
- Sponsor
- Daewoong Pharmaceutical Co. LTD.
Heart Failure, Volume Overload
Safety & Feasibility of DSR TherApy in Heart FAiluRe pAtients With Persistent Congestion
Feasibility and safety study of the alfapump DSR system in the treatment of volume overloaded heart failure subjects receiving high doses of loop diuretics.
- Trial name
- SAHARA (NCT04882358)
- Testing
- ALFAPUMP DSR (DIRECT SODIUM REMOVAL) SYSTEM, SGLT2 inhibitor
- Where
- 2 sites in Georgia
- Volunteers
- 24 people
- Sponsor
- Sequana Medical N.V.
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
Type 2 Diabetes Mellitus
A Study to Evaluate the Food Effect on Drug Availability, Pharmacokinetic (PK) Properties, Safety and Tolerability of Two Different Dose Combination Therapy of Saxagliptin/Dapagliflozin/Metformin Extended-release (XR) Against Individual Component Co-administration.
A Study to Assess the Fed-state Bioequivalence of a Triple Fixed-Combination Drug Product (FCDP) of 2.5 mg Saxagliptin / 5 mg Dapagliflozin / 1000 mg Metformin XR and 5 mg Saxagliptin /10 mg Dapagliflozin /1000 mg Metformin XR…
- Trial name
- NCT03169959
- Testing
- 2.5 mg Saxagliptin tablet, 5 mg dapagliflozin / 1000 mg metformin XR tablet, Triple FCDP - 2.5 mg saxagliptin / 5 mg dapagliflozin / 1000 mg metformin XR
- Where
- United States
- Volunteers
- 85 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Bioequivalence, Fixed Dose Combination Tablets
A Study to Assess the Bioequivalence of Dapagliflozin/Metformin XR Fixed-dose Combination Tablets in Healthy Subjects
This is a bioequivalence study to compare 2 fixed-dose combination tablets of dapagliflozin/metformin XR manufactured at 2 different plants in healthy subjects under fasting and fed conditions
- Conditions
- Bioequivalence, Fixed Dose Combination Tablets, Healthy Male and Female Subjects
- Trial name
- NCT02637037
- Testing
- dapagliflozin/metformin XR 5/500 mg test drug (Mount Vernon), dapagliflozin/metformin XR 5/500 mg reference drug (Humacao), dapagliflozin/metformin XR 10/1000 mg test drug (Mount Vernon)
- Where
- United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Type 2 Diabetes Mellitus
Characterization of the Kinetics of Renal Glucose Reabsorption in Response to Dapagliflozin in Healthy Subjects and in Subjects With Type 2 Diabetes Mellitus (T2DM)
It is anticipated that 7 days of oral administration of 10 mg dapagliflozin will reduce the renal glucose reabsorption similarly in healthy subjects and in subjects with T2DM.
- Trial name
- NCT01165268
- Testing
- Dapagliflozin
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Type2 Diabetes
Pharmacokinetic and Pharmacodynamic Drug-Drug Interaction of Evogliptin and Empagliflozin or Dapagliflozin in Healthy Male Adults
A Randomized, Open-label, Multiple-dose, Crossover Study to Investigate the Pharmacokinetic and Pharmacodynamic Drug-Drug Interaction of Evogliptin 5 mg and Empagliflozin 25 mg or Dapagliflozin 10 mg after Oral Administration in…
- Trial name
- NCT03766724
- Testing
- Evogliptin→Evogliptin+Empagliflozin→Empagliflozin, Empagliflozin→Evogliptin→Evogliptin+Empagliflozin, Evogliptin→Evogliptin+Dapagliflozin→Dapagliflozin
- Where
- South Korea
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Dong-A ST Co., Ltd.
Heart Failure, Reduced Ejection Fraction
Observation of Italian Patients With Heart Failure Being Treated With Dapagliflozin in Clinical Practice
This is an observational, non-interventional, longitudinal prospective descriptive study including participants diagnosed with Heart Failure with reduced Ejection Fraction (HFrEF) in Italy and initiated on treatment with…
- Trial name
- EVOLUTION-HF (NCT05250011)
- Testing
- Dapagliflozin
- Where
- 11 sites in Italy
- Volunteers
- 252 people
- Sponsor
- AstraZeneca
Type 2 Diabetes Mellitus
Trial to Evaluate the Efficacy and Safety of Dapagliflozin in Japanese Type 2 Diabetes Mellitus Patients
The purpose of this study is to obtain information on efficacy and safety of dapagliflozin in Japanese patients with Type 2 Diabetes. This will be done by comparing the effect of dapagliflozin to placebo when given in oral doses.
- Trial name
- NCT00972244
- Testing
- Dapagliflozin
- Where
- 20 sites in Japan
- Volunteers
- 417 people
- Sponsor
- AstraZeneca
Diabetes Mellitus, Type 2
iSGLT2 Inhibitor and a iDPP -4 Inhibitor in Treatment of Type 2 Diabetes Mellitus in Patients Treated With Metformin (TRIAD)
The present study aims to evaluate the efficacy and safety of different combinations of oral antidiabetics in patients with inadequate glycemic control on metformin monotherapy.
- Trial name
- TRIAD (NCT06560333)
- Testing
- N0892
- Where
- Brazil
- Sponsor
- Eurofarma Laboratorios S.A.
T2DM (Type 2 Diabetes Mellitus)
The Efficacy and Safety of DWP16001 in Combination With Metformin in Patients With Type 2 Diabetes.
Therapeutic Confirmatory Study to Evaluate the Efficacy and Safety of DWP16001 in Combination with Metformin in Patients With Type 2 Diabetes Mellitus who Have Inadequate Glycemic Control on Metformin Alone.
- Trial name
- ENHANCE-M (NCT04634500)
- Testing
- Dapagliflozin
- Where
- South Korea
- Volunteers
- 200 people
- Sponsor
- Daewoong Pharmaceutical Co. LTD.
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
Diabetes Mellitus, Type 2
Dapagliflozin Patient Satisfaction Survey
The purpose of this study is to evaluate the diabetes related treatment satisfaction for patients with type 2 diabetes mellitus
- Trial name
- NCT02805283
- Where
- United States
- Volunteers
- 653 people
- Sponsor
- AstraZeneca
Type 1 Diabetes Mellitus
BMS - Safety, Pharmacokinetics (PK) and Pharmacodynamics (PD) of Dapagliflozin in Type 1 Diabetes
To obtain safety and tolerability information in patients with type 1 diabetes where Dapagliflozin is added on to Insulin (for 14 days)
- Trial name
- NCT01498185
- Testing
- Dapagliflozin
- Where
- 12 sites in United States
- Volunteers
- 171 people
- Sponsor
- AstraZeneca