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 #854
Janssen-Cilag International NV (Janssen) today announced results from a post-hoc analysis which showed that at 52 weeks, canagliflozin provided reductions in both HbA1c and body weight in more patients with type 2 diabetes mellitus as an add-on to metformin, when compared with sitagliptin 100mg or glimepiride.1
This analysis used data from two separate randomised, double-blind, active-controlled Phase 3 studies of canagliflozin 100mg and 300mg versus either sitagliptin 100mg or glimepiride. Results showed a greater proportion of patients had reductions in both HbA1c and body weight with canagliflozin 100mg and 300mg compared with sitagliptin 100mg (67.7%, 74.7%, and 50.6%, respectively), or glimepiride (72.4%, 78.5%, and 26.8%, respectively). Canagliflozin 300mg was associated with the greatest reductions in HbA1c and body weight compared to sitagliptin 100mg and glimepiride.
Gisle Langslet, Senior Consultant at the Lipid Clinic, Oslo University Hospital said, “This post-hoc analysis adds to the breadth of data already available for canagliflozin. Weight reduction may play a role in the sustained HbA1c lowering effect of canagliflozin, which is important in the overall management of this condition. In addition, in my experience, the weight reduction experienced by most patients is of great importance for their physical and mental well-being.”
In both studies, changes in HbA1c and body weight were measured. In the first study comparing canagliflozin to sitagliptin, mean HbA1c changes from baseline were -0.73%, -0.88%, and -0.73%, and mean body weight changes from baseline were -3.8%, -4.2%, and -1.3% with canagliflozin 100mg and 300mg and sitagliptin 100mg, respectively.
In the second study comparing canagliflozin to glimepiride, mean HbA1c changes from baseline were -0.82%, -0.93%, and -0.81%, and mean body weight changes from baseline were -4.2%, -4.7%, and 1.0% with canagliflozin 100mg and 300mg and glimepiride, respectively.
A greater proportion of patients had reductions in both HbA1c and body weight with canagliflozin 100mg and 300mg compared with sitagliptin 100mg (67.7%, 74.7%, and 50.6%, respectively) or glimepiride (72.4%, 78.5%, and 26.8%, respectively). Of the patients that had a decrease in HbA1c, more saw either no change or an increase in body weight with sitagliptin or glimepiride versus canagliflozin 100mg and 300mg in both studies.
These results are to be presented, alongside ten other abstracts for canagliflozin, at the 50th European Association for the Study of Diabetes (EASD) Annual Meeting in Vienna, Austria (abstract #854).
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 disease.7
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 glycaemic 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 Langslet G et al. Canagliflozin reduces both HbA1c and body weight in patients with type 2 diabetes mellitus on background metformin. Data presented at the 50th European Association for the Study of Diabetes in Vienna, Austria (Abstract #854)
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
