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Canagliflozin

Phase 3

Diabetes Mellitus, Type 2 | Small molecule | Metabolic |Johnson & Johnson|Last Updated: Apr 25, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindNO_TREATMENT_CONTROLLEDDMCBiomarker
Total Trials18
Total Enrollment16,439
FDA Designations
No designations recorded
Clinical Trials (18)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03170518A Study to Investigate the Efficacy and Safety of Canagliflozin in Children and Adolescents (>=10 to <18 Years) With Type 2 Diabetes MellitusPHASE3 COMPLETED 171 — — Jul 21, 2017Sep 20, 2023Apr 25, 2025106 United States, Brazil +8
NCT02065791Evaluation of the Effects of Canagliflozin on Renal and Cardiovascular Outcomes in Participants With Diabetic NephropathyPHASE3 COMPLETED 4,401 — — Feb 17, 2014Oct 30, 2018Dec 5, 2019575 United States, Argentina +32
NCT01809327A Study to Evaluate the Effectiveness, Safety, and Tolerability of Canagliflozin in Combination With Metformin in the Treatment of Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control With Diet and ExercisePHASE3 COMPLETED 1,186 — — Jun 4, 2013Dec 2, 2014Jul 11, 2017129 United States, Argentina +11
NCT01381900A Efficacy, Safety, and Tolerability Study of Canagliflozin in Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin Alone or in Combination With a SulphonylureaPHASE3 COMPLETED 678 — — Aug 1, 2011Nov 1, 2012May 9, 201425 China, Malaysia +1
NCT01064414An Efficacy, Safety, and Tolerability Study of Canagliflozin in Patients With Type 2 Diabetes Mellitus Who Have Moderate Renal ImpairmentPHASE3 COMPLETED 272 — — Jun 1, 2010Aug 1, 2012Aug 14, 2013106 United States, Australia +16
NCT01106651A Safety and Efficacy Study of Canagliflozin in Older Patients (55 to 80 Years of Age) With Type 2 Diabetes MellitusPHASE3 COMPLETED 716 — — Jun 1, 2010May 1, 2013Nov 4, 201486 United States, Australia +15
NCT01106690The CANTATA-MP Trial (CANagliflozin Treatment and Trial Analysis - Metformin and Pioglitazone)PHASE3 COMPLETED 344 — — Jun 1, 2010Jul 1, 2012Jul 15, 201383 United States, Canada +9
NCT01106625The CANTATA-MSU Trial (CANagliflozin Treatment And Trial Analysis - Metformin and SUlphonylurea)PHASE3 COMPLETED 469 — — May 1, 2010Apr 1, 2012Jun 20, 201376 United States, Australia +10
NCT01106677The CANTATA-D Trial (CANagliflozin Treatment and Trial Analysis - DPP-4 Inhibitor Comparator Trial)PHASE3 COMPLETED 1,284 — — May 1, 2010May 1, 2012Jul 30, 2013125 United States, Argentina +20
NCT01081834The CANTATA-M (CANagliflozin Treatment and Trial Analysis - Monotherapy) TrialPHASE3 COMPLETED 678 — — Mar 1, 2010Mar 1, 2012Feb 23, 201778 United States, Austria +16
NCT01032629CANVAS - CANagliflozin cardioVascular Assessment StudyPHASE3 COMPLETED 4,330 — — Dec 9, 2009Feb 22, 2017Dec 7, 2018305 United States, Argentina +23
NCT00968812CANagliflozin Treatment And Trial Analysis-Sulfonylurea (CANTATA-SU) SGLT2 Add-on to Metformin Versus GlimepiridePHASE3 COMPLETED 1,452 — — Sep 1, 2009Jan 1, 2013Jan 30, 2017138 United States, Argentina +18
NCT01340664An Efficacy, Safety, and Tolerability Study of Canagliflozin in the Treatment of Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin MonotherapyPHASE2 COMPLETED 279 — — Jul 1, 2011Apr 1, 2012Sep 16, 201461 United States, Canada +5
NCT02009488Treatment Differences Between Canagliflozin and Placebo in Insulin Secretion in Subjects With Type 2 Diabetes Mellitus (T2DM)PHASE1 COMPLETED 59 — — Sep 8, 2014Jan 3, 2017Jan 4, 20182 United States
NCT02000700A Study to Evaluate the Pharmacokinetics, Pharmacodynamics and Safety of Canagliflozin in Older Children and Adolescents With Type 2 Diabetes MellitusPHASE1 COMPLETED 17 — — Mar 1, 2014Apr 1, 2016Mar 3, 201717 United States, Brazil
NCT01483781A Study of the Effects of Canagliflozin on Plasma Volume in Patients With Type 2 Diabetes MellitusPHASE1 COMPLETED 36 — — Dec 1, 2011Aug 1, 2012Aug 20, 20141 Germany
NCT01273558A Study of Two Methods for Determining the Renal Threshold for Glucose in Patients With Type 2 Diabetes MellitusPHASE1 COMPLETED 28 — — Jan 1, 2011Jul 1, 2011Apr 22, 20131 Germany
NCT01128985A Pharmacokinetic and Pharmacodynamic Study to Determine Blood Levels of JNJ-28431754 (Canagliflozin) in Patients With Type 2 Diabetes MellitusPHASE1 COMPLETED 39 — — Mar 1, 2010Jul 1, 2010May 29, 20132 United States
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Study Endpoints
Primary Endpoints
Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 26
Baseline (Day 1) and Week 26

Change from baseline in HbA1c at Week 26 was analyzed using a pattern mixture model with multiple imputation. Data for this outcome measure was planned to be collected and analyzed for the combined population of arm Canagliflozin 100 mg and Canagliflozin 300 mg.

Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
Baseline (Day 1) up to 30 days post last dose at Week 52 (up to Week 56)

An AE was any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non investigational) product. An AE did not necessarily have a causal relationship with the pharmaceutical/biological agent under study. TEAE was defined as the AEs occurring after first administration of double blind study intervention up to 30 days post last dose of study intervention.

Primary Composite Endpoint of Doubling of Serum Creatinine (DoSC), End-stage Kidney Disease (ESKD), and Renal or Cardiovascular (CV) Death
Up to 4.6 years

Primary composite endpoint is the composite of DoSC, ESKD, and renal or CV death. DoSC: from baseline average determination (sustained and confirmed by repeat central laboratory measure after at least 30 days and preferably within 60 days). ESKD: as initiation of maintenance dialysis for at least 30 days, or renal transplantation, or an estimated glomerular filtration rate (eGFR) value of less than (\<)15 milliliters per minute per 1.73 square meter (mL/min/1.73 m\^2) (sustained and confirmed by repeat central laboratory measure after at least 30 days and preferably within 60 days). Renal death: death in participants who had reached ESKD, died without initiating renal replacement therapy, and no other cause of death was determined via adjudication. Adjudication of these events by Endpoint Adjudication Committee (EAC) was performed in blinded fashion. Event rate estimated based on time to first occurrence of primary composite endpoint are presented.

Change in Glycated Hemoglobin (HbA1c) From Baseline at Week 26
Day 1 (Baseline) and Week 26

The change in the value of glycated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) from baseline at Week 26 was compared between the different treatment groups.

Change in Glycosylated Hemoglobin (HbA1c) From Baseline to Week 18
Day 1 (Baseline) and Week 18

The table below shows the least-squares (LS) mean change in HbA1c from baseline to Week 18 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.

Change in HbA1c From Baseline to Week 26
Day 1 (Baseline) and Week 26

The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.

Change in HbA1c From Baseline to Week 26 (Main Study)
Day 1 (Baseline) and Week 26

The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.

Change in HbA1c From Baseline to Week 26 (High Glycemic Substudy)
Day 1 (Baseline) and Week 26

The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 26 for each treatment group in patients randomized to the High Glycemic Substudy.

Major Adverse Cardiovascular Events (MACE) Composite of Cardiovascular (CV) Death, Non-Fatal Myocardial Infarction (MI), and Non-Fatal Stroke
Up to approximately 8 years

MACE, defined as a composite of CV death, non-fatal MI, and nonfatal stroke. Adjudication of these events by the Endpoint Adjudication Committee (EAC) was performed in a blinded fashion. Event rate estimated based on the time to the first occurrence of MACE are presented.

Change in HbA1c From Baseline to Week 52
Day 1 (Baseline) and Week 52

The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 52 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus glimepiride) in the LS mean change.

Change in HbA1c From Baseline to Week 18
Day 1 (Baseline) and Week 18

The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 18 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.

Change from baseline in hepatic insulin sensitivity
Baseline, 25 weeks
Change from baseline in peripheral tissue insulin sensitivity
Baseline, 25 weeks
Change from baseline in liver fat content, determined using magnetic resonance spectroscopy (MRS)
Baseline, 25 weeks
Change from baseline in insulin secretion rate (ISR) during mixed-meal tolerance test (MMTT)
Baseline, 25 weeks
Change from baseline in beta-cell glucose sensitivity, determined as a slope of ISR vs. plasma glucose concentration during MMTT
Baseline, 25 weeks
Plasma concentrations of canagliflozin following multiple oral doses of canagliflozin
From Days 14 to 17

Plasma concentrations of canagliflozin are used to evaluate how long canagliflozin stays in the body.

Change in plasma volume (PV)
Baseline to Week 12 of the double-blind treatment period

Baseline is defined as up to 3 days predose (Week -1)

Number of patients who experience at least 1 occurrence of a treatment-related adverse event
Day 1 to Day 85

Treatment-related adverse events are adverse events with onset during the treatment phase.

Number of hypoglycemic events reported
Baseline up to Day 98

Baseline is defined as up to 3 days predose (Week -1)

Change in electrocardiogram (ECG) parameters
Baseline up to Day 98

Baseline is defined as up to 3 days predose (Week -1)

Change in blood pressure measurements
Baseline up to Day 98

Baseline is defined as up to 3 days predose (Week -1)

Number of patients with physical examination findings reported as adverse events
Baseline up to Week 12

Baseline is defined as up to 3 days predose (Week -1)

Change from baseline in pulse rate (beats/minute)
Baseline up to Day 98

Baseline is defined as up to 3 days predose (Week -1)

Change in chemistry laboratory analytes
Baseline up to Day 98

Baseline is defined as up to 3 days predose (Week -1)

Change from baseline in urinalysis laboratory analytes
Baseline up to Day 98

Baseline is defined as up to 3 days predose (Week -1)

Change in hematology laboratory analytes
Baseline up to Day 98

Baseline is defined as up to 3 days predose (Week -1)

RTG values using the MMTT and the stepwise hyperglycemic clamp methods
On Days 1 and 2 (Part 1)
The concentration of canagliflozin and major metabolites (M5 and M7) in blood will be measured by protocol-specified pharmacokinetic parameters.
At protocol-specified time points through Day 7
Secondary Endpoints
Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 26 and 52
Baseline (Day 1), Weeks 26 and 52
Percentage of Participants With HbA1c Less Than (<)7.5 Percent (%), <7%, and <6.5% at Weeks 26 and 52
Weeks 26 and 52
Percentage of Participants Who Received Rescue Therapy
Baseline (Day 1) up to Week 52
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Single-blind run-in Period: PlaceboEXPERIMENTALParticipants will receive 1 placebo tablet matching canagliflozin 100 milligram (mg) once-daily during the 2-week single-blind placebo run-in period.
Double-blind Treatment Phase: Canagliflozin or PlaceboEXPERIMENTALCanagliflozin 100 mg/matching placebo once-daily during first 12 weeks. At Week 13, participants who have glycated hemoglobin (HbA1c) of greater than or equal to (\>=)7.0 percent (%), estimated glomerular filtration rate (eGFR) \>=60 milliliter/minute/1.73 meter square (mL/min/1.73 m\^2) will be re-randomized to either remain on canagliflozin 100 mg/matching placebo or up-titrate to canagliflozin 300 mg/matching placebo till Week 52.
Canagliflozin 100 mgEXPERIMENTALEach participant will receive 100 mg of canagliflozin once daily
PlaceboPLACEBO_COMPARATOREach participant will receive matching placebo once daily
Canagliflozin 300 mgEXPERIMENTALParticipants will receive one 300 mg canagliflozin capsule before the morning meal and one matching placebo capsule with the evening meal plus placebo tablets with the evening meal (to match the metformin XR tablets administered in other treatment arms) for 26 weeks.
Metformin XREXPERIMENTALParticipants will receive metformin XR tablets (in doses titrated over 9 weeks) once daily with the evening meal, plus one placebo capsule before the morning meal and one placebo capsule with the evening meal (to match the canagliflozin capsules administered in other treatment arms) for 26 weeks.
Canagliflozin 100 mg + Metformin XREXPERIMENTALParticipants will receive one 100 mg canagliflozin capsule with the evening meal and one matching placebo capsule before the morning meal plus metformin XR tablets (in doses titrated over 9 weeks) once daily with the evening meal for 26 weeks.
Canagliflozin 300 mg + Metformin XREXPERIMENTALParticipants will receive one 300 mg canagliflozin capsule with the evening meal and one matching placebo capsule before the morning meal plus metformin XR tablets (in doses titrated over 9 weeks) once daily with the evening meal for 26 weeks.
Canagliflozin 100mgEXPERIMENTALEach participant will receive 100 mg of canagliflozin once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
Canagliflozin 300mgEXPERIMENTALEach participant will receive 300 mg of canagliflozin once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
Placebo/SitagliptinOTHEREach patient will receive matching placebo once daily for 26 weeks with stable doses of metformin and pioglitazone. At Week 26, patients will be switched from placebo to 100 mg of sitagliptin once daily with stable doses of metformin and pioglitazone until Week 52.
Sitagliptin 100 mgACTIVE_COMPARATOREach patient will receive 100 mg of sitagliptin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
Canagliflozin (JNJ-28431754) 100 mgEXPERIMENTALEach patient will receive canagliflozin (JNJ-28431754) 100 mg once daily on background standard of care for diabetes once daily for the duration of the study
Canagliflozin (JNJ-28431754) 300 mgEXPERIMENTALEach patient will receive canagliflozin (JNJ-28431754) 300 mg once daily on background standard of care for diabetes once daily for the duration of the study
GlimepirideACTIVE_COMPARATOREach patient will receive glimepiride, at protocol-specified doses, once daily in combination with protocol-specified doses of metformin for 104 weeks.
Canagliflozin 50 mg bidEXPERIMENTALEach patient will receive 50 mg canagliflozin twice daily for 18 weeks.
Canagliflozin 150 mg bidEXPERIMENTALEach patient will receive 150 mg canagliflozin twice daily for 18 weeks
Canagliflozin (JNJ-28431754)EXPERIMENTALEach patient will receive canagliflozin 100 mg once daily during the first 4 weeks of the 25 weeks double-blind period, then the dose may be increased to 300 mg once daily, till the end of the period.
Canagliflozin (Dose Group 1)EXPERIMENTALParticipants will receive 100 mg (as 1 x 100-mg tablet) of canagliflozin daily for 14 days.
Canagliflozin (Dose Group 2)EXPERIMENTALParticipants will be enrolled into Dose Group 2 to receive either 50 mg (as 1 x 50-mg tablet) or 300 mg (as 1 x 300-mg tablet) of canagliflozin daily for 14 days.
CanagliflozinEXPERIMENTAL -
Part 1: no InterventionNO_INTERVENTIONIn Part 1 of the study, patients will not receive any study drug.
Part 2: canagliflozinEXPERIMENTALIn Part 2 of the study, patients will receive canagliflozin once daily on Days 1 through 8.
001EXPERIMENTALCanagliflozin 50 mg 50 mg capsule once daily for 7 consecutive days from Day 1 to Day 7
002EXPERIMENTALCanagliflozin 100 mg 100 mg capsule once daily for 7 consecutive days from Day 1 to Day 7
003EXPERIMENTALCanagliflozin 300 mg 300 mg capsule once daily for 7 consecutive days from Day 1 to Day 7.
004PLACEBO_COMPARATORPlacebo matching canagliflozin placebo once daily for 7 consecutive days from Day 1 to Day 7
Interventions
NameTypeDescription
Canagliflozin 100 mgDRUGCanagliflozin 100 mg tablet will be administered orally (by mouth) once-daily.
Canagliflozin 300 mgDRUGCanagliflozin 300 mg tablet will be administered orally once-daily.
PlaceboDRUGMatching placebo tablet will be administered orally once-daily.
CanagliflozinDRUGOne 100 mg over-encapsulated tablet orally once daily
Metformin XRDRUGOne 500 mg tablet (Day 1 up to week 1); two 500 mg tablets (Week 1 up to Week 3); three 500 mg tablets (Week 3 to Week 6); four 500 mg tablets (Week 6 to Week 9). Tablets will be administered with the evening meal.
Canagliflozin 100mgDRUGType=1, unit=mg, number=100, form=capsule, route=oral use. One capsule once daily for up to 18 weeks after completing a single-blind placebo run-in period (1 placebo capsule once daily for up to 2 weeks).
Canagliflozin 300mgDRUGType=1, unit=mg, number=300, form=capsule, route=oral use. One capsule once daily for up to 18 weeks after completing a single-blind placebo run-in period (1 placebo capsule once daily for up to 2 weeks).
MetforminDRUGThe participant's stable dose of background therapy of metformin should be continued throughout the study.
SulphonylureaDRUGThe participant's stable dose of background therapy of metformin plus sulphonylurea should be continued throughout the study.
Antihyperglycemic agent(s)DRUGStable doses of antihyperglycemic agents (sulfonylurea agent, thiazolidinediones, dipeptidyl peptidase 4 \[DPP-4\] inhibitors, metformin, insulin \[all types\]) and their combinations (sulfonylurea agent and insulin \[all types\], metformin and insulin \[all types\], metformin and sulfonylurea, alpha glucosidase inhibitors, thiazolidinediones, dipeptidyl peptidase 4 \[DPP-4\]) are used as per protocol specifications.
SitagliptinDRUGOne 100 mg over-encapsulated tablet orally once daily beginning at Week 26 until Week 52 with stable doses of metformin and pioglitazone.
PioglitazoneDRUGThe patient's stable dose of pioglitazone background therapy should be continued throughout the study.
SulphonylrueaDRUGThe patient's stable dose of background sulphonylurea therapy should be continued throughout the study.
Metformin immediate releaseDRUGThe patient's stable dose of metformin immediate release background therapy should be continued throughout the study.
Canagliflozin (JNJ-28431754) 100 mgDRUGOne 100 mg capsule taken orally (by mouth) once daily
Canagliflozin (JNJ-28431754) 300 mgDRUGOne 300 mg capsule taken orally (by mouth) once daily
GlimepirideDRUGGlimepiride will be given orally (by mouth), as over-encapsulated tablets, starting at a dose of 1mg once daily and increasing to a maximum of 6 mg or 8 mg once daily for 104 weeks.
Canagliflozin (JNJ-28431754)DRUGCanagliflozin (JNJ-28431754) will be given orally as over-encapsulated tablets, at a dose of 100 mg or 300 mg once daily for 104 weeks.
Canagliflozin 50 mgDRUGOne canagliflozin 50-mg capsule taken orally twice daily with a meal for 18 weeks
Canagliflozin 150 mgDRUG1 canagliflozin 150-mg capsule taken orally twice daily with a meal for 18 weeks
Canagliflozin, 100 mgDRUGOne 100 mg capsule taken orally (by mouth) once daily
Canagliflozin, 300 mgDRUGOne 300 mg capsule taken orally (by mouth) once daily
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Eligibility Criteria
Age Range10 Years — 17 Years
SexALL
Healthy VolunteersNo
Study Sites106

Inclusion Criteria: * Participants with a diagnosis of type 2 diabetes mellitus (T2DM) * Random C-peptide at screening greater than (\>)0.6 nanogram/milliliter (ng/mL) (\>0.2 nanomole/liter \[nmol\]/L\]) * HbA1c of greater than or equal to (\>=)6.5 percent (%) to less than or equal to (\<=)11.0% an...

Countries:United StatesBrazilChinaGreeceIndiaMalaysiaMexicoPhilippinesPolandRussiaArgentinaAustraliaBulgariaCanadaChileColombiaCzechiaFranceGermanyGuatemalaHungaryJapanLithuaniaNew ZealandPuerto RicoRomaniaSerbiaSlovakiaSouth AfricaSouth KoreaSpainTaiwanUkraineUnited Arab EmiratesUnited KingdomVietnamBelgiumLatviaHong KongSwedenSwitzerlandFinlandThailandIsraelEstoniaPeruPortugalSingaporeTurkey (Türkiye)AustriaIcelandLuxembourgNetherlandsNorwayCosta RicaDenmark
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