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Dapagliflozin/Metformin

Phase 1

Healthy | Small molecule | Other |AstraZeneca PLC|Last Updated: Jun 1, 2012

Target and mechanism

Molecular targetSLC5A2
Target classInhibitor
ModalitySmall molecule
ChEMBLCHEMBL429910

Also known as Dapagliflozin

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials2
Total Enrollment54

FDA Designations

No designations recorded

Clinical trial landscape

Dapagliflozin/Metformin · 4 trials · 2 indications

Phase 1 4
NCT01156246Study to Assess the Effect of Food on Combination Dapagliflozin/Metformin Tablet in Healthy VolunteersHealthy
COMPLETED18 Analytics
NCT01072578A Study to to Assess the Effect of Dapagliflozin When Administered Once a Day Versus Twice a Day on Blood GlucoseHealthy Volunteers
COMPLETED16 Analytics
NCT01055691A Study Comparing the Amount of Metformin and After Taking a Combination Tablet vs. Separate TabletsHealthy Volunteers
COMPLETED120 Analytics
NCT00688493Effects of Single Oral Dose Dapagliflozin QT StudyHealthy
COMPLETED36 Analytics
PHASE1COMPLETED
Study to Assess the Effect of Food on Combination Dapagliflozin/Metformin Tablet in Healthy Volunteers
Healthy
NCT0115624618
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PHASE1COMPLETED
A Study to to Assess the Effect of Dapagliflozin When Administered Once a Day Versus Twice a Day on Blood Glucose
Healthy Volunteers
NCT0107257816
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PHASE1COMPLETED
A Study Comparing the Amount of Metformin and After Taking a Combination Tablet vs. Separate Tablets
Healthy Volunteers
NCT01055691120
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PHASE1COMPLETED
Effects of Single Oral Dose Dapagliflozin QT Study
Healthy
NCT0068849336
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Study Endpoints

Primary Endpoints

To assess the effect of food on the pharmacokinetics of dapagliflozin and metformin.
Serial PK sampling will be done on Days 1-4 at visit 2 and 3.

primary - single dose Cmax, AUCinf, AUC(0-t) of dapagliflozin and metformin.. secondary - single dose tmax, t1/2 of dapagliflozin and metformin

Calculation of derivation of pharmacokinetic variables
Up to 14 blood samples will be obtained on day 1 (with the closest interval between samples being 15 minutes), one sample on days 3 and 4, and up to 21 samples on day 5
bioequivalence will be demonstrated if the 90% confidence interval (CI) for the formulation effect is contained within the interval of 0.8000-1.2500 for AUC(0-t), AUCinf and Cmax with respect to both dapagliflozin and metformin.
Immediately prior to administration of the investigational product (IP). After intake of IP PK blood samples will be drawn every 15 minutes for the first hour, every 30 minutes for the second hour and every hour up to 72 h after intake of IP.
Electronic measures of heart beats
ECGs (electronic measures of the heart) are taken at scheduled times during the 3 days after receiving each dose of study medication

Secondary Endpoints

To examine the safety and tolerability of the fixed-dose combination tablet of dapagliflozin and metformin.
ECG at screening and follow-up. BP/pulse at screening, once daily during residential period and at follow-up. Clinical chemistry, haematology, and urine analyses at screening, day-1, day 4, and at follow-up.
Calculation of derivation of pharmacodynamic variables (inhibition of plasma glucose re-absorption, 24 hour urine glucose excretion, inhibition of rate of gut glucose absorption by measuring plasma glucose, insulin and GIP).
plasma glucose will be drawn on Day 5, creatinine will be drawn at pre-dose of Day 4 and of Day 5, glucose and insulin will be drawn on Day 5 , Day 5 for GIP, urine will be collected on Day 5 in 4-hour intervals
To examine the safety and tolerability of the combination of dapagliflozin and metformin
Adverse events and laboratory variables assessed throughout both 5-day treatment periods, and a follow-up visit 5-10 days later
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
1EXPERIMENTALDapagliflozin/metformin tablet, high fat, high calorie breakfast day 1, visit 2, 7-14 days wash-out, Dapagliflozin/metformin tablet, fasting conditions day 1, visit 3.
2EXPERIMENTALDapagliflozin/metformin tablet, fasting conditions day 1, visit 2, 7-14 days wash-out, Dapagliflozin/metformin tablet, high fat, high calorie breakfast day 1, visit 3.
3EXPERIMENTALFixed dose combination dapagliflozin/metformin IR tablets followed by free combination of dapagliflozin tablet and metform IR tablet
4EXPERIMENTALFree combination of dapagliflozin tablet and metform IR tablet followed by fixed dose combination dapagliflozin/metformin IR tablets
20 mg single dose of dapagliflozinEXPERIMENTAL20 mg dapagliflozin
150 mg single dose of dapagliflozin2EXPERIMENTAL150 mg dapagliflozin
400 mg single dose of moxifloxacinACTIVE_COMPARATORMoxifloxacin
PlaceboPLACEBO_COMPARATORPlacebo

Interventions

NameTypeDescription
Dapagliflozin/MetforminDRUGoral fixed dose combination tablet 5 mg Dapagliflozin / 1000 mg Metformin given on day 1 at visit 2 and 3.
DapagliflozinDRUGDapagliflozin tablets 5 mg, Oral Twice daily dose for 5 days (total daily dose 10 mg)
MetforminDRUGmetformin IR tablet 850 mg Oral Single dose
MoxifloxacinDRUGOverencapsulated 400 mg capsule, single oral dose
Placebo to match moxifloxacin and dapagliflozinDRUGOverencapsulated 400 mg capsule, single oral dose
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy * BMI 18-30 kg/m2 Exclusion Criteria: * History of clinically significant illness. * History of alcohol or drug abuse

Countries:SwedenGermanyUnited States
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Frequently asked questions about Dapagliflozin/Metformin

What is Dapagliflozin used for?

Dapagliflozin is an investigational small molecule being developed for cardiovascular and metabolic conditions, including diabetes mellitus, chronic kidney disease, heart failure with preserved ejection fraction, and type 1 diabetes mellitus. It is also studied in healthy volunteers for bioequivalence assessments. The drug is in Phase 3 clinical development.

Who makes Dapagliflozin?

Dapagliflozin is developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker AZN. The company is conducting clinical trials to evaluate the drug's safety and efficacy across multiple indications.

What phase is Dapagliflozin in?

Dapagliflozin is in Phase 3 clinical development. It has completed 20 clinical trials with a total enrollment of 17,379 participants. The trials are randomized, double-blind, and placebo-controlled, indicating a rigorous evaluation process for the drug's efficacy and safety.

What clinical trials is Dapagliflozin in?

Dapagliflozin has completed several clinical trials, including NCT01294436 in Japanese subjects with type 2 diabetes, NCT02279407 for liver fat in diabetic patients, NCT03877237 for heart failure with reduced ejection fraction, and NCT04856007 for bioequivalence in healthy Chinese subjects. All trials are completed.

Is Dapagliflozin the same as Farxiga?

Dapagliflozin is also known by the brand name Farxiga, which is a medication used to treat type 2 diabetes. In clinical trials, it is being studied for additional indications such as heart failure and chronic kidney disease. The drug is developed by AstraZeneca.

Other drugs targeting SLC5A2

Empagliflozin BAYRY· PHASE3 Empagliflozin COLL· PHASE3 Sotagliflozin DXCM· PHASE3 Empagliflozin GILD· PHASE1 Sotagliflozin LXRX· PHASE3 Sotagliflozin followed by 3 drugs in a random order LXRX· EARLY_PHASE1