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Janssen Research & Development to Present Latest Phase 3 Results for Canagliflozin in the Treatment of Patients With Type 2 Diabetes



9/25/2012 10:18:47 AM

RARITAN, N.J., Sept. 25, 2012 /PRNewswire/ -- Janssen Research & Development, LLC (Janssen) will present new Phase 3 data results evaluating canagliflozin, an investigational sodium glucose co-transporter 2 (SGLT2) inhibitor, in adult patients with type 2 diabetes at the upcoming annual meeting of the European Association for the Study of Diabetes (EASD), from October 1-5, 2012 in Berlin, Germany.

"The data we will present at EASD are the latest results from our comprehensive Phase 3 program evaluating canagliflozin in a range of patients with type 2 diabetes, including those on insulin therapy considered to be at elevated risk of cardiovascular disease, and in patients aged 55 to 80, who are more likely to have other significant medical conditions," said Kirk Ways, M.D., Ph.D., Vice President of Clinical Development for canagliflozin at Janssen.

The 10 canagliflozin abstracts that will be presented at the 2012 annual meeting of the EASD are as follows. All times listed as Central European Summer Time (CEST). The EASD program is available here: http://87.234.226.93/easd_intranet/easdwebfiles/annualmeeting/48thmeeting/2012/Prog-at-Glance.html. Please note that all abstracts accepted for presentation at EASD are subject to the organizers' embargo policies.

Oral presentation on Friday, October 5th, from 11:30-11:45 AM

  • Efficacy and safety of canagliflozin, a sodium glucose co-transporter 2 inhibitor, compared with sitagliptin in patients with type 2 diabetes on metformin plus sulphonylurea (Abstract 243; results from DIA3015)

Oral presentation on Friday, October 5th, from 11:45 AM-12:00 PM

  • Canagliflozin lowers postprandial plasma glucose and insulin excursions by delaying intestinal glucose absorption in addition to increasing urinary glucose excretion (Abstract 244; results from the Phase I study DIA1022)

Poster presentations on Wednesday, October 3rd, from 1:15-2:15 PM

  • Canagliflozin, a sodium glucose co-transporter 2 (SGLT2) inhibitor, improves glycemic control and is well tolerated in type 2 diabetes subjects with moderate renal impairment (Abstract 759; results from DIA3004)
  • Canagliflozin, a sodium glucose co-transporter 2 (SGLT2) inhibitor, improves glycemic control in subjects with type 2 diabetes inadequately controlled with diet and exercise (Abstract 760; results from DIA3005)
  • Canagliflozin, a sodium glucose co-transporter 2 (SGLT2) inhibitor, improves indices of beta cell function in patients with type 2 diabetes on metformin plus sulphonylurea (Abstract 761; results from DIA3002)
  • Canagliflozin, a sodium glucose co-transporter 2 (SGLT2) inhibitor, reduces body weight mainly through loss of fat mass in subjects with type 2 diabetes (Abstract 762; body composition analysis of results from DIA3009 and DIA3010)
  • Efficacy and safety of canagliflozin, a sodium glucose co-transporter 2 inhibitor (SGLT2), compared with glimepiride in patients with type 2 diabetes on background metformin (Abstract 763; results from DIA3009)
  • Efficacy and safety of canagliflozin, an inhibitor of sodium glucose co-transporter 2 (SGLT2), added-on to insulin therapy +/- oral agents in type 2 diabetes (Abstract 764; results from CANVAS, also known as DIA3008)
  • Efficacy and safety of canagliflozin, a sodium glucose co-transporter 2 inhibitor (SGLT2), in older subjects with type 2 diabetes mellitus (Abstract 765; results from DIA3010)
  • Canagliflozin, a sodium glucose co-transporter 2 inhibitor, improves glycemia in subjects with type 2 diabetes inadequately controlled with metformin plus sulphonylurea (Abstract 766; results from DIA3002)

About Canagliflozin
Canagliflozin is an investigational sodium glucose co-transporter 2 (SGLT2) inhibitor for the treatment of patients with type 2 diabetes. The kidneys of people with type 2 diabetes reabsorb greater amounts of glucose back into the body compared to non-diabetic people, which may contribute to elevated glucose levels. Canagliflozin blocks the reabsorption of glucose by the kidney, increasing glucose excretion and lowering blood glucose levels.

The global Phase 3 canagliflozin clinical program, which enrolled more than 10,300 patients in nine studies, is the largest late-stage development program for an investigational pharmacologic product for the treatment of type 2 diabetes submitted to health authorities to date. The program evaluated the safety and efficacy of canagliflozin across the spectrum of type 2 diabetes management, from adult patients treated only with diet and exercise to those requiring insulin injections to maintain glycemic control, and in three large studies in special populations: older patients with type 2 diabetes, patients with type 2 diabetes who have had moderate renal impairment, and patients with type 2 diabetes who had or were at high risk for developing cardiovascular disease. In May 2012, Janssen filed a New Drug Application for canagliflozin with the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with type 2 diabetes; Janssen filed a Marketing Authorization Application (MAA) with the European Medicines Agency (EMA) for a similar indication in June.

Janssen and its affiliates have rights to canagliflozin through a license agreement with Mitsubishi Tanabe Pharma Corporation. Janssen Pharmaceuticals, Inc. and its affiliates have marketing rights in North America, South America, Europe, Middle East, Africa, Australia, New Zealand and parts of Asia.

About Janssen
At Janssen, we are dedicated to addressing and solving some of the most important unmet medical needs of our time in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Driven by our commitment to patients, we develop innovative products, services and healthcare solutions to help people throughout the world. Janssen Research & Development, LLC and Janssen Pharmaceuticals, Inc. are part of the Janssen Pharmaceutical Companies of Johnson & Johnson. Please visit http://www.janssenrnd.com for more information.

Media contacts:
Ernie Knewitz
Phone: (908) 927-2953
Mobile: (917) 697-2318
eknewitz@its.jnj.com

Christina Chan
Phone: (908) 927-5769
Mobile: (908) 635-2406
cchan20@its.jnj.com

Investor contacts:
Stan Panasewicz
Phone: (732) 524-2524

Louise Mehrotra
Phone: (732) 524-6491

SOURCE Janssen Research & Development, LLC


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