John P H Wilding1, Lawrence Blonde2, Lawrence A Leiter3, Sonia Cerdas4, Cindy Tong5, Jacqueline Yee5, Gary Meininger5. 1. Department of Obesity and Endocrinology, University of Liverpool, Liverpool, United Kingdom. Electronic address: J.P.H.Wilding@liverpool.ac.uk. 2. Department of Endocrinology, Diabetes, and Metabolic Diseases, Ochsner Medical Center, New Orleans, LA, USA. 3. Keenan Research Centre in the Li Ka Shing Knowledge Institute of St. Michael's Hospital; Division of Endocrinology and Metabolism, University of Toronto, Toronto, ON, Canada. 4. Hospital Cima, Centro de Investigacíon Clínica San Agustín, San José, Costa Rica. 5. Janssen Research & Development, LLC, Raritan, NJ, USA.
Abstract
AIMS: Canagliflozin, a sodium glucose co-transporter 2 inhibitor, has demonstrated glycemic improvements across studies of patients with type 2 diabetes mellitus (T2DM). The impact of canagliflozin on HbA1c lowering was assessed by baseline HbA1c and known duration of T2DM. METHODS: This post hoc analysis pooled data from patients with T2DM enrolled in four 26-week, placebo-controlled, Phase 3 studies of canagliflozin (N=2313). Change in HbA1c from baseline to Week 26 was assessed in the overall population and in subgroups by baseline HbA1c (<8.0%, 8.0%-<9.0%, and ≥9.0%) and known duration of T2DM (<5 years, 5-<10 years, and ≥10 years). RESULTS: Relative to placebo, canagliflozin 100 and 300 mg provided greater HbA1c reductions in the overall population. Progressively larger placebo-subtracted reductions in HbA1c with canagliflozin 100 and 300 mg were seen with increasing baseline HbA1c. HbA1c reductions were similar across subgroups based on known duration of T2DM. Both canagliflozin doses were generally well tolerated across subgroups, with a safety and tolerability profile consistent with that seen in Phase 3 studies. CONCLUSIONS:Canagliflozin provided glycemic improvements in patients with T2DM across a range of baseline HbA1c and known duration of T2DM.
RCT Entities:
AIMS: Canagliflozin, a sodium glucose co-transporter 2 inhibitor, has demonstrated glycemic improvements across studies of patients with type 2 diabetes mellitus (T2DM). The impact of canagliflozin on HbA1c lowering was assessed by baseline HbA1c and known duration of T2DM. METHODS: This post hoc analysis pooled data from patients with T2DM enrolled in four 26-week, placebo-controlled, Phase 3 studies of canagliflozin (N=2313). Change in HbA1c from baseline to Week 26 was assessed in the overall population and in subgroups by baseline HbA1c (<8.0%, 8.0%-<9.0%, and ≥9.0%) and known duration of T2DM (<5 years, 5-<10 years, and ≥10 years). RESULTS: Relative to placebo, canagliflozin 100 and 300 mg provided greater HbA1c reductions in the overall population. Progressively larger placebo-subtracted reductions in HbA1c with canagliflozin 100 and 300 mg were seen with increasing baseline HbA1c. HbA1c reductions were similar across subgroups based on known duration of T2DM. Both canagliflozin doses were generally well tolerated across subgroups, with a safety and tolerability profile consistent with that seen in Phase 3 studies. CONCLUSIONS:Canagliflozin provided glycemic improvements in patients with T2DM across a range of baseline HbA1c and known duration of T2DM.
Authors: Willem de Winter; Adrian Dunne; Xavier Woot de Trixhe; Damayanthi Devineni; Chyi-Hung Hsu; Jose Pinheiro; David Polidori Journal: Br J Clin Pharmacol Date: 2017-01-31 Impact factor: 4.335