JANSSEN-CILAG

Poster presented Tuesday 16 ^th September 14:15 – 15:15 (Vienna Time)

Note: This press release corresponds to EASD abstracts No. 826 and No. 817

Janssen-Cilag International NV (Janssen) today announced analyses based on head-to-head studies of INVOKANA^® (canagliflozin) versus JANUVIA (sitagliptin) as dual and triple therapy options with metformin and metformin plus sulfonylureas, respectively, amongst patients with type 2 diabetes. These data highlight the importance of weight change for weight-related quality of life (WRQoL) and physical health satisfaction (HS) and support the cost effectiveness of canagliflozin.¹ These results were presented at the 50^th European Association for the Study of Diabetes in Vienna, Austria (abstract No. 826 and No. 817 ).

In the analysis of the dual-therapy study, patients were categorised as “continuing weight loss”, “prior weight loss with partial regain” or “no weight loss or complete regain” based on trajectory of weight loss through week 52, to fully reflect the patient experience over time. Compared to patients with “no weight loss or complete regain” through week 52, patients with “continuing weight loss” were approximately twice as likely to show improvements in WRQoL (OR: 2.21, 95% CI 1.25, 3.90) and in HS (OR: 1.98, 95% CI 1.27, 3.08). Patients with prior weight loss were about 50% more likely to show improvements in HS (OR 1.56, 95% CI 1.08, 2.25). Among those who improved, a higher proportion of patients were assigned to canagliflozin treatment versus sitagliptin.

In the previously reported (ADA 2013 ) head-to-head study of canagliflozin versus sitaglitpin as dual therapy with metformin canagliflozin 100mg and 300mg was associated with a mean weight loss of 3.3kg and 3.7kg respectively, compared to a 1.2kg mean weight loss with sitagliptin, after 52 weeks of treatment.²

"Weight management is a critical factor in managing type 2 diabetes. Our results indicate that the average amount of weight loss demonstrated with canagliflozin treatment in the clinical trial, as well as thoughts and feelings about temporal patterns of weight change, are important determinants of weight-related quality of life and physical health satisfaction, ” said Dr Shana Traina, Director, Patient Reported Outcomes, Janssen Global Services. “Therefore, it is important to consider the patient experience when collaborating with individuals on weight and disease management strategies .”

In addition to the weight related quality of life data, the long-term cost-effectiveness of canagliflozin versus sitagliptin as a third-line therapy in the treatment of type 2 diabetes in the UK was also presented (abstract No. 817 ). The study suggests that the use of canagliflozin 300mg versus sitagliptin 100mg as an add-on therapy in patients inadequately controlled on a background of metformin and sulfonylurea is likely to be cost-effective compared to using sitagliptin 100mg and thus a more efficient use of limited health care resources.³

In this study, the outcomes and costs associated with canagliflozin 300mg compared to sitagliptin 100mg in triple therapy were simulated over 40 years using a validated micro-simulation model, the Economic and Health Outcomes Model of type 2 diabetes (ECHO-T2DM). The cost-effectiveness of using canagliflozin 300mg versus sitagliptin 100mg was assessed in two patient groups; the first had demographic and health characteristics reflecting those of the patients in the previously reported canagliflozin versus sitagliptin trial;⁴ the second reflected those of patients with type 2 diabetes in The Health Improvement Network (THIN) database, a large, anonymised, primary care, electronic medical record data resource representative of the UK population.

The simulation results indicated that for both populations, the use of canagliflozin 300mg compared to sitagliptin 100mg as an add-on in patients inadequately controlled on metformin plus sulfonylureas, increased Quality-Adjusted Life Years (QALYs) and yielded incremental cost-effectiveness ratios deemed generally acceptable from a societal perspective in the UK.

The results presented are among a total of 10 presentations on canagliflozin at the 50^th European Association for the Study of Diabetes in Vienna, Austria.

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.⁵

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.^2,6 A third study compared canagliflozin to glimepiride as dual therapy with metformin which showed a lower risk of hypoglycaemia.⁷ 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: patients over age 55 with type 2 diabetes⁸ and patients with type 2 diabetes who were considered to be at high risk for cardiovascular disease.⁹

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.⁵

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.¹⁰

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.¹¹ The World Health Organisation estimates that 90% of the diabetes population has type 2 diabetes.¹²

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

No. No. No.

¹ Traina S et al. Impact of weight-related quality of life and health satisfaction: evidence from a head-to-head study of canagliflozin vs. sitagliptin. Data presented at the 50^th European Association for the Study of Diabetes in Vienna, Austria, (abstract No. 826 )

² 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

³ Thompson G et al. The cost effectiveness of canagliflozin versus sitagliptin as a third-line therapy in the treatment of type 2 diabetes mellitus in the UK. Data presented at the 50^th European Association for the Study of Diabetes in Vienna, Austria, (abstract No. 817 )

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 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

⁶ 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

⁷ 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.

⁸ 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.

⁹ 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

¹⁰ International Diabetes Federation. About Diabetes. Available http://www.idf.org/about-diabetes . Last Accessed: June 2014

¹¹ International Diabetes Federation. IDF Diabetes Atlas, 6th edn.   Brussels, Belgium: International Diabetes Federation, 2013.  http://www.idf.org/diabetesatlas . Last accessed June 2014

¹² World Health Organisation. Media Centre – Diabetes fact sheets. Available at: http://www.who.int/mediacentre/factsheets/fs312/en/ Last accessed July 2014

Contact:

Janssen-Cilag
Media contact:
Brigitte Byl
Europe Middle-East & Africa
Phone: +32 (0)14 60 7172
or
Investor contacts:
Stan Panasewicz
Phone: +1(732) 524-2524
or
Louise Mehrotra
Phone: +1(732) 524-6491

Link:

ClickThru