Vokanamet (canagliflozin/immediate release metformin FDC) / Mundipharma, J&J - LARVOL DELTA

Comparison chart: Sodium-glucose cotransporter 2 (SGLT2) inhibitors. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Noninsulin drugs for type 2 diabetes. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Ecofriendly appraisal of stability-indicating high-performance chromatographic assay of canagliflozin and metformin with their toxic impurities; in silico toxicity prediction. (PubMed, J Sep Sci) - "The proposed method was validated as per the International Conference of Harmonization and applied for the assay of Vokanamet tablets. The separation was achieved using acetone:ethyl acetate:acetic acid (8:2:0.2, by volume) as scanning eluted bands at 205 nm. For minimal environmental impact; greenness profile appraisal of the proposed assay was performed by three greenness assessment approaches; analytical Eco-Scale, Green Analytical Procedure Index, and Greenness metric approaches."

Journal • Immunology • Inflammation • Nephrology • Renal Calculi • Renal Disease

Drugs for type 2 diabetes. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

A Study to Assess Safety of Canagliflozin and Metformin Hydrochloride Combination Given as a Supplement to Diet and Exercise to Improve Blood Sugar Level in Indian Adult Participants With Diabetes (clinicaltrials.gov) - P4 | N=276 | Completed | Sponsor: Johnson & Johnson Private Limited | Active, not recruiting ➔ Completed

Trial completion • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

SOLDMiDiab02: Evaluation of SGLT2-i Effectivness and Safety in Elderly Type 2 Diabetes Patients (clinicaltrials.gov) - P=N/A | N=800 | Not yet recruiting | Sponsor: University of Milan

New trial • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

A Study to Assess Safety of Canagliflozin and Metformin Hydrochloride Combination Given as a Supplement to Diet and Exercise to Improve Blood Sugar Level in Indian Adult Participants With Diabetes (clinicaltrials.gov) - P4 | N=276 | Active, not recruiting | Sponsor: Johnson & Johnson Private Limited | Trial primary completion date: Jan 2022 ➔ Jul 2022

Trial primary completion date • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

A Study to Assess Safety of Canagliflozin and Metformin Hydrochloride Combination Given as a Supplement to Diet and Exercise to Improve Blood Sugar Level in Indian Adult Participants With Diabetes (clinicaltrials.gov) - P4 | N=276 | Active, not recruiting | Sponsor: Johnson & Johnson Private Limited | Recruiting ➔ Active, not recruiting

Enrollment closed • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

[VIRTUAL] The Safety and Efficacy of Canagliflozin in Women with Polycystic Ovary Syndrome: A Randomized Control Trial (ADA 2021) - "Our study showed that canagliflozin was not significantly inferior to metformin in PCOS patients with IR, which suggested SGLT2 inhibitor should be considered as an effective drug in the treatment of patients with PCOS."

Clinical • Late-breaking abstract • Metabolic Disorders

'Good News' From the FDA: Label Changes for Dulaglutide, Canagliflozin (Medscape) - "Today I'm going to discuss two label changes from the FDA: one for dulaglutide and one for canagliflozin....The FDA says that prescribers should weigh a patient's risk for amputation when selecting antidiabetes medicines. It is still on the label, but it's not a black box warning. Again, this is good news because the FDA says the risk isn't as high as they once thought."

Regulatory • Video

Comparison chart: SGLT2 inhibitors. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal

A Study to Assess Safety of Canagliflozin and Metformin Hydrochloride Combination Given as a Supplement to Diet and Exercise to Improve Blood Sugar Level in Indian Adult Participants With Diabetes (clinicaltrials.gov) - P4; N=276; Recruiting; Sponsor: Johnson & Johnson Private Limited; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

In brief: Canagliflozin and lower limb amputations. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Mundipharma Welcomes the New 2020 Clinical Practice Guideline from KDIGO recommending SGLT2is alongside metformin as first-line anti-hyperglycaemic therapy in type 2 diabetes patients with chronic kidney disease (Businesswire) - "As the European distributor of Invokana® (canagliflozin) and Vokanamet® (canagliflozin and metformin), Mundipharma welcomes the publication of the first KDIGO (Kidney Disease: Improving Global Outcomes) 2020 Clinical Practice Guideline for Diabetes Management in Chronic Kidney Disease (CKD). The new guideline recommends the use of sodium-glucose co-transporter-2 inhibitor (SGLT2i) class, which includes canagliflozin, as a first-line treatment option alongside metformin for the management of hyperglycaemia in patients with type 2 diabetes mellitus (T2DM), CKD and eGFR ≥30 ml/min/1.73 m2."

Clinical guideline • Chronic Kidney Disease • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

"🔊 New FDA Drug Safety #Podcast on canagliflozin (Invokana, Invokamet, Invokamet XR) : https://t.co/dXLbl8BlRy. View prescribing information(s): https://t.co/NI9hOS9DCH" (@FDA_Drug_Info)

Clinical

A Study to Assess Safety of Canagliflozin and Metformin Hydrochloride Combination Given as a Supplement to Diet and Exercise to Improve Blood Sugar Level in Indian Adult Participants With Diabetes (clinicaltrials.gov) - P4; N=276; Not yet recruiting; Sponsor: Johnson & Johnson Private Limited; Trial completion date: Mar 2023 ➔ Jun 2022

Trial completion date • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

A Study to Assess Safety of Canagliflozin and Metformin Hydrochloride Combination Given as a Supplement to Diet and Exercise to Improve Blood Sugar Level in Indian Adult Participants With Diabetes (clinicaltrials.gov) - P4; N=276; Not yet recruiting; Sponsor: Johnson & Johnson Private Limited; Trial completion date: Jan 2022 ➔ Jun 2022

Clinical • Trial completion date • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

A Study to Assess Safety of Canagliflozin and Metformin Hydrochloride Combination Given as a Supplement to Diet and Exercise to Improve Blood Sugar Level in Indian Adult Participants With Diabetes (clinicaltrials.gov) - P4; N=276; Not yet recruiting; Sponsor: Johnson & Johnson Private Limited; Trial completion date: Jun 2022 ➔ Mar 2023

Clinical • Trial completion date • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

A Study to Assess the Bioequivalence of the Metformin Component of the Fixed Dose Combination Tablet of Canagliflozin and Metformin Extended Release With Respect to Metformin XR Tablet Co-administered With Canagliflozin in Healthy Fed and Fasted Participants (clinicaltrials.gov) - P1; N=44; Completed; Sponsor: Janssen Research & Development, LLC; Recruiting ➔ Completed

Trial completion • Biosimilar

A study to assess the bioequivalence of 2 fixed dose combination (FDC) tablets of canagliflozin and metformin immediate release (IR) (50 mg/1,000 mg) with respect to the individual components of canagliflozin (1 x 100 mg) and metformin IR tablets (2 x 1,0 (clinicaltrials.gov) - P1, N=64; Recruiting -> Active, not recruiting

Enrollment closed • Diabetes

A Bioequivalence Study of the Fixed Dose Combination Tablets of Canagliflozin and Metformin Extended Release (XR) With Respect to the Individual Components in Healthy Fed Participants (clinicaltrials.gov) - P1; N=3; Completed; Sponsor: Janssen Research & Development, LLC; Recruiting -> Completed

Trial completion • Biosimilar

A Bioequivalence Study of the Fixed Dose Combination Tablets of Canagliflozin and Metformin Extended Release (XR) With Respect to the Individual Components (clinicaltrials.gov) - P1; N=2; Completed; Sponsor: Janssen Research & Development, LLC; N=42 -> 2

Enrollment change • Acute Coronary Syndrome • Biosimilar • Chronic Kidney Disease • Heart Failure

FDA issues complete response letter for canagliflozin/metformin fixed-dose combination therapy for type 2 diabetes (PRNewswire) - "...it has received from the U.S. Food and Drug Administration (FDA) a complete response letter regarding its New Drug Application (NDA) for a fixed-dose combination (FDC) of canagliflozin and immediate-release metformin to treat adults with type 2 diabetes....requested additional information to support the comparability of the twice-daily dosing regimen of canagliflozin -- as part of the canagliflozin and metformin FDC -- and the once-daily dosing of canagliflozin as a single agent. Janssen believes it can supply this information based on available clinical data from the comprehensive Phase 3 clinical development program for canagliflozin."

FDA event • Diabetes

Vokanamet (canagliflozin and immediate release metformin hydrochloride fixed dose combination) approved in the European Union for treatment of adults with type 2 diabetes (J&J Press Release) - "Janssen-Cilag International NV (Janssen) announced...that the European Commission (EC) has approved VOKANAMET...in the European Union, for the treatment of adults with type 2 diabetes mellitus to improve glycaemic control....The combination therapy, which is taken as a single pill twice daily, is indicated in adults aged 18 years and older with type 2 diabetes mellitus to improve glycaemic control..."

European regulatory • Diabetes

Janssen Research & Development submits new drug application to U.S. FDA for canagliflozin/metformin fixed-dose combination therapy to treat patients with type 2 diabetes (J&J) - "...has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for a fixed-dose therapy combining canagliflozin and immediate release metformin to treat patients with type 2 diabetes."

Regulatory • Diabetes