VIENNA--(BUSINESS WIRE)--
Poster to be presented on Thursday 18th September 2014 13:00-14:00 (Vienna Time)
Note: This press release corresponds to EASD abstract #855
Janssen-Cilag International NV (Janssen) today announced results from four 26-week placebo-controlled studies and pooled data from two 52-week active controlled trials, showing that INVOKANA® (canagliflozin) relative to placebo was efficacious across the spectrum of insulin sensitivity and beta cell function in lowering blood glucose.1 These results are among 10 abstracts for canagliflozin being presented at the 50th European Association for the Study of Diabetes (EASD) Annual Meeting in Vienna, Austria (abstract #855).
“By producing and secreting insulin to the body via the pancreas, beta cells play an important role in regulating blood glucose levels. However, for type 2 diabetes patients, this process is less effective and results in an eventual decline of beta cell function, a key cornerstone to the pathophysiology of type 2 diabetes,” said Professor Matthews, Professor of Diabetes Medicine at the University of Oxford. "The data presented today provides evidence that canagliflozin can benefit patients, regardless of their insulin sensitivity or beta-cell function, which means that this treatment may be an option for a broad range of patients.”
The analysis to be presented at the EASD congress highlighted results from pooled data from four 26-week studies of canagliflozin as monotherapy, add-on to metformin, add-on to metformin plus sulfonylurea and add-on to metformin plus pioglitazone, which showed that canagliflozin was efficacious relative to placebo, across the spectrum of insulin sensitivity and beta cell function in lowering blood glucose. In a second analysis, the two 52-week active-controlled studies comparing canagliflozin (300mg) with sitagliptin (100mg) observed similar results.
Additional results from pooled data of the two 52-week studies showed that;
- Greater reductions in blood glucose levels were observed with canagliflozin (300mg) than with sitagliptin (100mg), with the biggest differences observed in patients with higher baseline HbA1c and in patients with low insulin sensitivity.
- Efficacy of both canagliflozin and sitagliptin increased with increasing baseline blood glucose (p<0.001).
Canagliflozin was first approved in the European Union in 2013 and continues to be approved in a growing number of countries worldwide.
About INVOKANA® (canagliflozin)
INVOKANA® (canagliflozin) is a member of a new class of drugs known as sodium glucose co-transporter 2 (SGLT2) inhibitors.
SGLT2 inhibitors contribute to controlling blood glucose levels via the kidney. As glucose is filtered from the blood into the kidneys, it is reabsorbed back into the bloodstream. An important transport carrier in the renal proximal tubule responsible for this reabsorption is called sodium glucose co-transporter 2 (SGLT2). Canagliflozin selectively inhibits SGLT2, and, as a result, promotes the loss of glucose via the urine, lowering blood glucose levels in adults with type 2 diabetes. This mechanism of action is independent of insulin.2
In November 2013, the European Commission approved INVOKANA® (canagliflozin) in the European Union for the treatment of adults with type 2 diabetes mellitus, to improve glycaemic control.
Canagliflozin has been studied as monotherapy and in combination with other type 2 diabetes therapies including insulin. The comprehensive global phase 3 clinical trial programme for canagliflozin enrolled 10,285 patients in nine studies and is one of the largest programmes for a pharmacological product for the treatment of type 2 diabetes.
The Phase 3 programme evaluated the safety and efficacy of canagliflozin across the spectrum of type 2 diabetes and included placebo and active comparator controlled studies. Three studies have compared canagliflozin to current standard treatments; two of which compared canagliflozin to sitagliptin which demonstrated a significant blood pressure reduction and a similar tolerability profile.3,4 A third study compared canagliflozin to glimepiride as dual therapy with metformin which showed a lower risk of hypoglycaemia.5 In all three comparator studies, canagliflozin 300mg provided greater and sustained reductions in HbA1c compared to those on placebo or an active comparator with the additional effect of significant weight reduction.
The Phase 3 programme also included two large studies in special populations:6,7 patients over age 55 with type 2 diabetes6 and patients with type 2 diabetes who were considered to be at high risk for cardiovascular disease7.
Adverse drug reactions related to the mode of action of SGLT2 inhibitors, and also associated with canagliflozin, include genital mycotic infections, urinary tract infections (UTIs), adverse events related directly to the osmotic diuresis (such as urinary frequency or thirst), and adverse events related to reduced intravascular volume (such as postural dizziness), as well as constipation, and a low incidence of rash or urticarial.2
About Type 2 Diabetes
Type 2 diabetes is a chronic condition that affects the body’s ability to metabolise sugar, or glucose, and is characterised by the inability of pancreatic beta cell function to keep up with the body’s demand for insulin.8
The International Diabetes Federation estimates that, in 2013, 382 million people globally were living with diabetes (type 1 and 2), and this diabetes population is expected to grow to over 592 million by 2035. In 2013, it was estimated that over 56 million people were living with diabetes in Europe.9 The World Health Organisation estimates that 90% of the diabetes population has type 2 diabetes.10
If left uncontrolled, type 2 diabetes can lead to serious long-term microvascular and macrovascular complications. Improved glycemic control has been demonstrated to reduce the onset and progression of these complications.
About Janssen
The Janssen Pharmaceutical Companies of Johnson & Johnson are dedicated to addressing and solving the most important unmet medical needs of our time, including oncology, immunology, neuroscience, infectious disease, and cardiovascular and metabolic diseases.
Driven by our commitment to patients, Janssen develops innovative products, services and healthcare solutions to help people throughout the world.
More information can be found at www.janssen-emea.com
References
1 Matthews D et al. Glycaemic efficacy of canagliflozin is largely independent of baseline beta cell function or insulin sensitivity. Data presented at the 50th European Association for the Study of Diabetes in Vienna, Austria (abstract #855)
2 INVOKANA SmPC. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-Summary_for_the_public/human/002649/WC500156455.pdf. Last accessed: June 2014
3 Lavalle-González FJ et al. Efficacy and safety of canagliflozin compared with placebo and sitagliptin in patients with type 2 diabetes on background metformin monotherapy: a randomised trial. Diabetologia. 2013;56(12):2582-92
4 Schernthaner G et al. Canagliflozin compared with sitagliptin for patients with type 2 diabetes who do not have adequate glycemic control with metformin plus sulfonylurea: a 52-week randomized trial. Diabetes Care. 2013; 36(9):2508-15
5 Cefalu WT et al. Efficacy and safety of canagliflozin versus glimepiride in patients with type 2 diabetes inadequately controlled with metformin (CANTATA-SU): 52 week results from a randomised, double-blind, phase 3 non-inferiority trial. Lancet. 2013; 382(9896):941-50.
6 Bode B et al. Efficacy and safety of canagliflozin treatment in older subjects with type 2 diabetes mellitus: a randomized trial. Hosp Pract. 2013;41(2):72-84.
7 Neal B, Perkovic V, et al. (2013). Rationale, design, and baseline characteristics of the Canagliflozin Cardiovascular Assessment Study (CANVAS)—A randomized placebo-controlled trial. American Heart Journal; 166(2): 217-223
8 International Diabetes Federation. About Diabetes. Available http://www.idf.org/about-diabetes. Last Accessed: June 2014
9 International Diabetes Federation. IDF Diabetes Atlas, 6th edn. Brussels, Belgium: International Diabetes Federation, 2013. http://www.idf.org/diabetesatlas. Last accessed June 2014
10 World Health Organisation. Media Centre – Diabetes fact sheets. Available at: http://www.who.int/mediacentre/factsheets/fs312/en/ Last accessed July 2014
