LATE BREAKING ABSTRACTS Abstract #1300 ACHIEVING A COMPOSITE ENDPOINT OF A1C, BODY WEIGHT, AND SYSTOLIC BLOOD PRESSURE REDUCTION WITH CANAGLIFLOZIN IN PATIENTS WITH TYPE 2 DIABETES

1300 ACHIEVING A COMPOSITE ENDPOINT OF A1C, BODY WEIGHT, AND SYSTOLIC BLOOD PRESSURE REDUCTION WITH CANAGLIFLOZIN IN PATIENTS WITH TYPE 2 DIABETES Katherine Merton, PhD, MBA1, Michael Davies, PhD1, Ujjwala Vijapurkar, PhD2, Doreen Inman, PharmD, MBA, BCPS, CDE1, Gary Meininger, MD2 1. Janssen Scientific Affairs, LLC, 2. Janssen Research & Development, LLC Objective: Achieving glycemic control, weight loss, and blood pressure (BP) reduction are important components of type 2 diabetes mellitus (T2DM) management as many patients with T2DM are overweight/obese and/or have hypertension. Canagliflozin (CANA), an SGLT2 inhibitor, has demonstrated improvements in glycemic control along with reductions in body weight and BP in patients with T2DM. This post hoc analysis evaluated achievement of a composite endpoint of A1C, body weight, and systolic BP (SBP) reduction with CANA versus placebo (PBO). Methods: This analysis was based on pooled data from four 26-week, randomized, double-blind, PBO-controlled, Phase 3 studies in patients with T2DM (N = 2,313; mean age, 56 y; A1C, 8.0%; body weight, 89 kg; SBP, 128 mmHg). The proportion of patients with T2DM achieving the composite endpoint of A1C reduction ≥0.5%, body weight reduction ≥3%, and SBP reduction ≥4 mmHg at 26 weeks with CANA 100 or 300 mg versus PBO was evaluated. Results: The proportions of patients meeting treatment goals were similar across groups at baseline. At Week 26, greater least squares mean reductions in A1C (–0.85%, –1.04%, and –0.13%), body weight (–2.8%, –3.5%, and –0.6%), and SBP (–4.3, –5.0, and –0.3 mmHg) were seen with CANA 100 and 300 mg compared with PBO, respectively. A greater proportion of patients met the individual A1C, body weight, and SBP treatment targets with CANA 100 and 300 mg versus PBO. Overall, 68.3%, 74.3%, and 34.2% of patients achieved A1C reduction ≥0.5% with CANA 100 and 300 mg and PBO, respectively (differences vs PBO [95% confidence interval (CI)] of 34.1% [29.1, 39.1] and 40.1% [35.2, 45.0]); 44.6%, 56.3%, and 17.2%, respectively, achieved body weight reduction ≥3% (differences vs PBO [95% CI] of 27.4% [22.8, 32.0] and 39.2% [34.6, 43.8]); and 49.9%, 52.3%, and 37.8%, respectively, achieved SBP reduction ≥4 mmHg (differences [95% CI] of 12.1% [6.9, 17.3] and 14.5% [9.2, 19.7]). A greater proportion of patients treated with CANA 100 and 300 mg versus PBO achieved the composite endpoint of A1C reduction ≥0.5%, body weight reduction ≥3%, and SBP ABSTRACTS – Late Breaking reduction ≥4 mmHg at Week 26 (21.1%, 25.3%, and 5.7%, respectively; differences vs PBO [95% CI] of 15.4% [12.0, 18.9] and 19.6% [16.0, 23.2]). CANA was generally well tolerated, with a safety profile similar to that seen in across Phase 3 CANA studies. Conclusion: Patients with T2DM were more likely to achieve clinically important reductions in A1C, body weight, and SBP with CANA versus PBO.