PMID- 26984361 OWN - NLM STAT- PubMed-not-MEDLINE DCOM- 20160610 LR - 20240330 IS - 1869-6953 (Print) IS - 1869-6961 (Electronic) IS - 1869-6961 (Linking) VI - 7 IP - 2 DP - 2016 Jun TI - Simultaneous Reduction in Both HbA1c and Body Weight with Canagliflozin Versus Glimepiride in Patients with Type 2 Diabetes on Metformin. PG - 269-78 LID - 10.1007/s13300-016-0163-1 [doi] AB - INTRODUCTION: Canagliflozin, a sodium glucose co-transporter 2 (SGLT2) inhibitor, has demonstrated sustained improvements in glycemic control and body weight reductions with treatment for up to 104 weeks in a broad range of patients with type 2 diabetes mellitus (T2DM). METHODS: This was a post hoc analysis of individual patient data (N = 1450) from a randomized, double-blind, placebo-controlled, Phase 3 study comparing canagliflozin with glimepiride as add-on to metformin in patients with T2DM during a 52-week core period followed by a 52-week extension period. The number of patients who achieved a reduction from baseline in both HbA1c and body weight with canagliflozin 100 and 300 mg and glimepiride was assessed at Weeks 52 and 104. Safety was recorded as adverse events (AEs) during the study. RESULTS: Canagliflozin 100 and 300 mg provided durable glycemic improvements and body weight reductions compared with glimepiride over 104 weeks. At Week 52, the proportion of patients who achieved reductions in both HbA1c and body weight was 72.4% with canagliflozin 100 mg, 78.5% with canagliflozin 300 mg, and 26.8% with glimepiride; similar results were observed at Week 104 (65.5%, 71.1%, and 26.8% with canagliflozin 100 and 300 mg and glimepiride, respectively). The AE profile of canagliflozin was comparable to that observed in previous studies, with increased incidence of AEs related to the mechanism of SGLT2 inhibition (e.g., genital mycotic infections, urinary tract infections, and osmotic diuresis-related AEs) and a low risk of hypoglycemia. CONCLUSION: More patients treated with canagliflozin experienced reductions in both HbA1c and body weight compared with glimepiride for up to 104 weeks. Canagliflozin was generally well tolerated in patients with T2DM when used in combination with metformin. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT00968812. FUNDING: Janssen Research & Development, LLC. FAU - Leiter, Lawrence A AU - Leiter LA AD - Keenan Research Centre in the Li Ka Shing Knowledge Institute of St. Michael's Hospital, University of Toronto, Toronto, ON, Canada. leiterl@smh.ca. FAU - Langslet, Gisle AU - Langslet G AD - Lipid Clinic, Oslo University Hospital, Oslo, Norway. FAU - Vijapurkar, Ujjwala AU - Vijapurkar U AD - Janssen Research & Development, LLC, Raritan, NJ, USA. FAU - Davies, Michael J AU - Davies MJ AD - Janssen Scientific Affairs, LLC, Raritan, NJ, USA. FAU - Canovatchel, William AU - Canovatchel W AD - Janssen Research & Development, LLC, Raritan, NJ, USA. LA - eng SI - ClinicalTrials.gov/NCT00968812 PT - Journal Article DEP - 20160316 PL - United States TA - Diabetes Ther JT - Diabetes therapy : research, treatment and education of diabetes and related disorders JID - 101539025 PMC - PMC4900973 OTO - NOTNLM OT - Body weight OT - Canagliflozin OT - Glimepiride OT - Glycated hemoglobin OT - Sodium glucose co-transporter 2 (SGLT2) inhibitor OT - Type 2 diabetes mellitus EDAT- 2016/03/18 06:00 MHDA- 2016/03/18 06:01 PMCR- 2016/03/16 CRDT- 2016/03/18 06:00 PHST- 2016/01/19 00:00 [received] PHST- 2016/03/18 06:00 [entrez] PHST- 2016/03/18 06:00 [pubmed] PHST- 2016/03/18 06:01 [medline] PHST- 2016/03/16 00:00 [pmc-release] AID - 10.1007/s13300-016-0163-1 [pii] AID - 163 [pii] AID - 10.1007/s13300-016-0163-1 [doi] PST - ppublish SO - Diabetes Ther. 2016 Jun;7(2):269-78. doi: 10.1007/s13300-016-0163-1. Epub 2016 Mar 16.