Canagliflozin

Generic Name: Canagliflozin

Brand Names: Invokamet, Invokana

Drug Type: Small Molecule

Chemical Formula: C_₂₄H_₂₅FO_₅S

CAS Number: 842133-18-0

Unique Ingredient Identifier: 6S49DGR869

Background: Canagliflozin, also known as Invokana, is a sodium-glucose cotransporter 2 (SGLT2) inhibitor used in the management of type 2 diabetes mellitus along with lifestyle changes including diet and exercise .

It was initially approved by the FDA in 2013 for the management of diabetes and later approved in 2018 for a second indication of reducing the risk of cardiovascular events in patients diagnosed with type 2 diabetes mellitus , .

Canagliflozin is the first oral antidiabetic drug approved for the prevention of cardiovascular events in patients with type 2 diabetes . Cardiovascular disease is the most common cause of death in these patients .

Indication: This drug is used in conjunction with diet and exercise to increase glycemic control in adults diagnosed with type 2 diabetes mellitus .

Another indication for canagliflozin is the prevention of major cardiovascular events (myocardial infarction, stroke, or death due to a cardiovascular cause) in patients with type 2 diabetes, as well as hospitalization for heart failure in patients with type 2 diabetes.

In addition to the above, canagliflozin can be used to lower the risk of end-stage kidney disease and major increases in serum creatinine and cardiovascular death for patients with a combination of type 2 diabetes mellitus, diabetic nephropathy, and albuminuria.

It is important to note that this drug is not indicated for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis .

Associated Conditions: Cardiovascular Mortality, End Stage Renal Disease (ESRD), Hospitalizations, Major Adverse Cardiac Events, Type 2 Diabetes Mellitus, Doubling of serum creatinine

Clinical Trials

A Study to Observe Clinical Effectiveness of Canagliflozin 300 mg Containing Treatment Regimens in Indian Type 2 Diabetes Participants With BMI>25 kg/m^2, in Real World Clinical Setting

Completed

Conditions: Diabetes Mellitus, Type 2

Interventions: Drug: Canagliflozin 300 mg

First Posted Date: 2018-07-27

Last Posted Date: 2020-08-19

Lead Sponsor: Johnson & Johnson Private Limited

Target Recruit Count: 178

Registration Number: NCT03604224

Locations: 🇮🇳
Dr. A. Ramachandran's Diabetes Hospitals, Chennai, India
🇮🇳
Apollo Hospitals, Kolkata, India
🇮🇳
Diacon Hospital, Bangalore, India

A Study for Comparison of Canagliflozin Versus Alternative Antihyperglycemic Treatments on Risk of Heart Failure Hospitalization and Amputation for Participants With Type 2 Diabetes Mellitus and the Subpopulation With Established Cardiovascular Disease

Completed

Conditions: Diabetes Mellitus, Type 2
Cardiovascular Diseases

Interventions: Drug: Dipeptidyl Peptidase-4 (DPP-4) Inhibitors
Drug: Empagliflozin
Drug: Canagliflozin
Drug: Dapagliflozin
Drug: Glucagon-like Peptide-1 (GLP-1) Agonist
Drug: Anti-hyperglycemic Agents (AHA)
Drug: Thiazolidinediones (TZD)
Drug: Sulfonylureas (SU)
Drug: Insulin

First Posted Date: 2018-04-10

Last Posted Date: 2018-08-27

Lead Sponsor: Janssen Research & Development, LLC

Target Recruit Count: 714582

Registration Number: NCT03492580

Locations: 🇺🇸
Janssen Investigative Site, Titusville, New Jersey, United States

Efficacy and Safety of Canagliflozin (TA-7284) in Patients With Diabetic Nephropathy

Phase 3

Completed

Conditions: Diabetic Nephropathy

Interventions: Drug: Canagliflozin
Drug: Placebo

First Posted Date: 2018-02-19

Last Posted Date: 2024-07-15

Lead Sponsor: Mitsubishi Tanabe Pharma Corporation

Target Recruit Count: 308

Registration Number: NCT03436693

Locations: 🇯🇵
Research site, Yamaguchi, Japan

Impact of a Short-term Treatment With Canagliflozin (Canacardia-HF)

Not Applicable

Withdrawn

Conditions: Type2 Diabetes
Heart Failure

Interventions: Drug: Placebo oral capsule
Drug: Canagliflozin 100mg
Radiation: PET imaging

First Posted Date: 2017-09-29

Last Posted Date: 2024-12-13

Lead Sponsor: Université de Sherbrooke

Registration Number: NCT03298009

An Efficacy Study of Canagliflozin or Sitagliptin to Determine Glucose Variability in Mexican Participants With Type 2 Diabetes Mellitus Inadequately Controlled on Metformin

Phase 4

Completed

Conditions: Diabetes Mellitus, Type 2

Interventions: Drug: Canagliflozin 300 mg
Drug: Sitagliptin 100 mg
Drug: Metformin

First Posted Date: 2017-08-30

Last Posted Date: 2019-11-29

Lead Sponsor: Janssen Research & Development, LLC

Target Recruit Count: 64

Registration Number: NCT03267576

Locations: 🇲🇽
Investigación Clínica Especializada, Guadalajara, Mexico
🇲🇽
Consultorio Privado en Unidad de Patología Clínica, Guadalajara, Mexico
🇲🇽
Instituto Nacional de Ciencias Medicas y Nutrición Salvador Zubirán, Mexico City, Mexico

and more 2 locations

Cardiovascular Outcomes in Participants With Type 2 Diabetes Mellitus (T2DM)

Completed

Conditions: Diabetes Mellitus, Type 2

Interventions: Drug: Dipeptidyl Peptidase-4 Inhibitor (DPP-4)
Drug: Canagliflozin
Drug: Glucagon-Like Peptide-1 Agonist (GLP-1)
Drug: Empagliflozin
Drug: Thiazolidinedione (TZD)
Drug: Dapagliflozin
Drug: Sulfonylureas
Drug: Insulin

First Posted Date: 2017-08-15

Last Posted Date: 2017-11-21

Lead Sponsor: Janssen Research & Development, LLC

Target Recruit Count: 25358

Registration Number: NCT03249506

Locations: 🇺🇸
Health ResearchTx, LLC, Trevose, Pennsylvania, United States

Effects of Canagliflozin on Intravascular Volume and Hemodynamics

Phase 4

Withdrawn

Conditions: Cardiovascular Diseases
Type2 Diabetes Mellitus

Interventions: Drug: Placebo
Drug: Canagliflozin 300mg

First Posted Date: 2017-06-19

Last Posted Date: 2017-10-12

Lead Sponsor: The University of Texas Health Science Center at San Antonio

Registration Number: NCT03190798

Locations: 🇺🇸
The University of Texas Health Science Center at San Antonio, San Antonio, Texas, United States

A Study to Investigate the Efficacy and Safety of Canagliflozin in Children and Adolescents (>=10 to <18 Years) With Type 2 Diabetes Mellitus

Phase 3

Completed

Conditions: Diabetes Mellitus, Type 2

Interventions: Drug: Canagliflozin 100 mg
Drug: Canagliflozin 300 mg
Drug: Placebo

First Posted Date: 2017-05-31

Last Posted Date: 2025-04-25

Lead Sponsor: Janssen Research & Development, LLC

Target Recruit Count: 171

Registration Number: NCT03170518

Locations: 🇺🇸
Buckeye Health and Research, LLC, Columbus, Ohio, United States
🇺🇸
Sante Clinical Research, Kerrville, Texas, United States
🇧🇷
Hospital e Maternidade Dr Christovao da Gama S.A, Santo Andre, Brazil

and more 103 locations