Canagliflozin Provided Substantial and Sustained Glycemic Improvements as Monotherapy and in Add-On Combinations in Adul

DIA3009 is a 52-week randomized, double-blind, active-controlled Phase 3 trial in 1,450 adult patients with inadequate glycemic control on maximally effective doses of metformin. Patients were randomized and treated once daily with either canagliflozin (100 mg or 300 mg) or glimepiride (with up-titration of glimepiride allowed throughout the 52-week period). Patients treated with canagliflozin had a sustained decrease in A1C, with statistically greater A1C-lowering for canagliflozin 300 mg after 52 weeks when compared to glimepiride (-0.93% and -0.81%, respectively, with the between group difference of -0.12%, 95% CI -0.22; -0.02); the decrease in A1C with canagliflozin 100 mg (-0.82%) was similar to that for glimepiride (between group difference of -0.01%, 95% CI -0.11; 0.09). In the key secondary endpoint measures, both the 300 mg and 100 mg canagliflozin dose groups provided reductions in body weight, with no notable change in the glimepiride group (body weight % change, -4.7 and -4.2 and 1.0, respectively). Hypoglycemia episodes occurred at a low incidence with canagliflozin 300 mg and 100 mg, and at a higher incidence with glimepiride (% of patients with 1 or more episodes: 4.9 and 5.6 and 34.2, respectively). Reductions in fasting plasma glucose were consistent with the primary endpoint for canagliflozin 300 mg and 100 mg and glimepiride (-27.5 and -24.3 and -18.3 mg/dL, respectively); other secondary endpoints included reductions in systolic blood pressure with both doses of canagliflozin and no notable change with glimepiride (-4.6 and -3.3 and 0.2 mmHg, respectively); HDL-C increased with both 300 mg and 100 mg doses of canagliflozin, with no notable change with glimepiride (% change, 9.0 and 7.9 and 0.3, respectively); LDL-C rose with both doses of canagliflozin more than with glimepiride (% change, 14.1 and 9.6 and 5.0, respectively).

The incidence of AEs and discontinuations due to AEs were generally similar across all treatment arms. AEs were mild to moderate and the overall incidence was balanced across treatment arms. Adverse events related to osmotic diuresis such as increased urination, genital mycotic infections in men and women, and urinary tract infections were more frequent in patients treated with canagliflozin than glimepiride; these specific adverse events were generally mild or moderate in intensity and infrequently led to discontinuation.

To access the abstract, visit http://www.abstractsonline.com/plan/Adva... and search for abstract number 38-LB.

Janssen presented results from three additional Phase 3 studies at this year's ADA meeting, which also demonstrate the potential value of canagliflozin across the spectrum of type 2 diabetes management including use in monotherapy, in add-on combination, and in patients with moderate renal impairment.

        
        - "Canagliflozin, a Sodium Glucose Co-Transporter 2 Inhibitor, Improves
          Glycemia and is Well Tolerated in Type 2 Diabetes Mellitus Subjects with Moderate
          Renal Impairment" on June 10 (
          http://www.abstractsonline.com/plan/Adva..., abstract 41-LB).
        - "Canagliflozin, a Sodium Glucose Co-Transporter 2 Inhibitor, Improves Glycemic
          Control and Lowers Body Weight in Subjects With Type 2 Diabetes Inadequately
          Controlled With Diet and Exercise" on June 9 (
          http://www.abstractsonline.com/plan/Adva..., abstract 81-OR).
        - "Canagliflozin, a Sodium Glucose Co-Transporter 2 Inhibitor, Improves Glycemic
          Control and Reduces Body Weight in Subjects with Type 2 Diabetes Inadequately
          Controlled With Metformin and Sulfonylurea" on June 9 (
          http://www.abstractsonline.com/plan/Adva..., abstract 1022-P).

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 Research & Development, LLC

Janssen Research & Development, LLC is headquartered in Raritan, N.J. and has affiliated facilities in Europe, the United States and Asia. Janssen Research & Development is leveraging a combination of internal and external innovation to discover and develop novel medicines and solutions in five distinct therapeutic areas: Neuroscience, Oncology, Immunology, Infectious Diseases and Vaccines, and Cardiovascular and Metabolism. Janssen Research & Development is part of the Janssen Pharmaceutical Companies of Johnson & Johnson.

For more information about Janssen Research & Development, LLC visit http://www.janssenrnd.com.

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, we develop innovative products, services and healthcare solutions to help people throughout the world.

More information can be found at http://www.janssen-emea.com

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