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Canagliflozin

Generic Name
Canagliflozin
Brand Names
Invokamet, Invokana
Drug Type
Small Molecule
Chemical Formula
C24H25FO5S
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

The CANTATA-D2 Trial (CANagliflozin Treatment And Trial Analysis - DPP-4 Inhibitor Second Comparator Trial)

Phase 3
Completed
Conditions
Diabetes Mellitus, Type 2
Interventions
First Posted Date
2010-06-04
Last Posted Date
2015-01-15
Lead Sponsor
Janssen Research & Development, LLC
Target Recruit Count
756
Registration Number
NCT01137812

A Pharmacokinetic and Pharmacodynamic Study to Determine Blood Levels of JNJ-28431754 (Canagliflozin) in Patients With Type 2 Diabetes Mellitus

Phase 1
Completed
Conditions
Diabetes Mellitus, Type 2
Interventions
First Posted Date
2010-05-24
Last Posted Date
2013-05-29
Lead Sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Target Recruit Count
39
Registration Number
NCT01128985

A Safety and Efficacy Study of Canagliflozin in Older Patients (55 to 80 Years of Age) With Type 2 Diabetes Mellitus

Phase 3
Completed
Conditions
Diabetes Mellitus, Type 2
Interventions
Drug: Antihyperglycemic agent(s)
Drug: Placebo
First Posted Date
2010-04-20
Last Posted Date
2014-11-04
Lead Sponsor
Janssen Research & Development, LLC
Target Recruit Count
716
Registration Number
NCT01106651

The CANTATA-MP Trial (CANagliflozin Treatment and Trial Analysis - Metformin and Pioglitazone)

Phase 3
Completed
Conditions
Diabetes Mellitus, Type 2
Interventions
First Posted Date
2010-04-20
Last Posted Date
2013-07-15
Lead Sponsor
Janssen Research & Development, LLC
Target Recruit Count
344
Registration Number
NCT01106690

The CANTATA-MSU Trial (CANagliflozin Treatment And Trial Analysis - Metformin and SUlphonylurea)

Phase 3
Completed
Conditions
Diabetes Mellitus, Type 2
Interventions
Drug: Placebo
Drug: Sulphonylruea
First Posted Date
2010-04-20
Last Posted Date
2013-06-20
Lead Sponsor
Janssen Research & Development, LLC
Target Recruit Count
469
Registration Number
NCT01106625

The CANTATA-D Trial (CANagliflozin Treatment and Trial Analysis - DPP-4 Inhibitor Comparator Trial)

Phase 3
Completed
Conditions
Diabetes Mellitus, Type 2
Interventions
First Posted Date
2010-04-20
Last Posted Date
2013-07-30
Lead Sponsor
Janssen Research & Development, LLC
Target Recruit Count
1284
Registration Number
NCT01106677

The CANTATA-M (CANagliflozin Treatment and Trial Analysis - Monotherapy) Trial

Phase 3
Completed
Conditions
Diabetes Mellitus, Type 2
Interventions
First Posted Date
2010-03-05
Last Posted Date
2017-02-23
Lead Sponsor
Janssen Research & Development, LLC
Target Recruit Count
678
Registration Number
NCT01081834

An Efficacy, Safety, and Tolerability Study of Canagliflozin in Patients With Type 2 Diabetes Mellitus Who Have Moderate Renal Impairment

Phase 3
Completed
Conditions
Diabetes Mellitus, Type 2
Renal Insufficiency
Interventions
Drug: Placebo
First Posted Date
2010-02-08
Last Posted Date
2013-08-14
Lead Sponsor
Janssen Research & Development, LLC
Target Recruit Count
272
Registration Number
NCT01064414

CANVAS - CANagliflozin cardioVascular Assessment Study

Phase 3
Completed
Conditions
Diabetes Mellitus, Type 2
Cardiovascular Diseases
Risk Factors
Interventions
First Posted Date
2009-12-15
Last Posted Date
2018-12-07
Lead Sponsor
Janssen Research & Development, LLC
Target Recruit Count
4330
Registration Number
NCT01032629

CANagliflozin Treatment And Trial Analysis-Sulfonylurea (CANTATA-SU) SGLT2 Add-on to Metformin Versus Glimepiride

Phase 3
Completed
Conditions
Diabetes Mellitus, Type 2
Interventions
First Posted Date
2009-08-31
Last Posted Date
2017-01-30
Lead Sponsor
Janssen Research & Development, LLC
Target Recruit Count
1452
Registration Number
NCT00968812
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