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ObjectiveTo assess the efficacy and safety of iGlarLixi (titratable fixed-ratio combination of insulin glargine (iGlar) and lixisenatide) in patients with type 2 diabetes (T2D) living in North America (NA; USA and Canada) compared with the rest of the world (RoW).Research design and methodsPost hoc analysis included patient-level data from 509 sites/centers across two phase III trials: LixiLan-O (NCT02058147; insulin-naive patients; NA, n=371; RoW, n=796) and LixiLan-L (NCT02058160; inadequately controlled patients on basal insulin; NA, n=196; RoW, n=535). Efficacy outcomes were: change from baseline to Week 30 in glycated hemoglobin (HbA1c), postprandial glucose (PPG), PPG excursions, fasting plasma glucose (FPG) and body weight; proportion of patients achieving HbA1c <42 mmol/mol (<7.0%); proportion of patients achieving composite endpoint: HbA1c <42 mmol/mol (<7.0%), no weight gain or symptomatic hypoglycemia (blood glucose ≤3.9 mmol/L (≤70 mg/dL)). Safety endpoints included incidence of documented symptomatic hypoglycemia and gastrointestinal (GI) adverse events.ResultsSignificantly larger reductions (p≤0.003) in HbA1c from baseline to Week 30 were achieved with iGlarLixi, compared with iGlar or lixisenatide, in NA and RoW patients in LixiLan-O (iGlarLixi vs iGlar: −0.31 and −0.29, respectively; iGlarLixi vs lixisenatide: −0.84 and −0.69, respectively) and in LixiLan-L (iGlarLixi vs iGlar: −0.5 and −0.51, respectively). Documented symptomatic hypoglycemia was similar between NA and RoW patients. iGlarLixi resulted in significant weight benefits versus iGlar (change from baseline –1.58 and –1.29 kg for NA and RoW patients, respectively; p<0.001). GI adverse events were similar for iGlarLixi and iGlar, but significantly higher for lixisenatide.ConclusionsiGlarLixi improved glycemic parameters versus iGlar or lixisenatide alone in both NA and RoW patients, with beneficial weight effects versus iGlar. iGlarLixi treatment responses, hypoglycemia risk and GI adverse events in NA patients were comparable with patients in the RoW.Trial registryClinicaltrials.govNCT02058147andNCT02058160.-

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The On Time education program is an innovative, online point-of-care tool designed to uncover and address barriers to insulin initiation, and to facilitate timely insulin initiation, when appropriate, in insulin-naïve individuals with type 2 diabetes (T2D). A total of 195 health care professionals (HCPs) completed online profiles of 1025 insulin-naïve individuals with T2D currently treated with non-insulin antihyperglycemic agents (NIAHAs) and with a glycated hemoglobin (A1C) above the Diabetes Canada target (for most individuals ≤7%). After having completed the discussion tool and questionnaires, participating HCPs were asked to evaluate the program, tool, and questionnaires. Mean age of participants was 61.2 years; 55% were male; mean duration of diabetes was 10.5 years. For the majority of participants (70%) the recommended A1C target was ≤7.0%. On average, participants were prescribed 2.6 NIAHAs, mainly metformin and dipeptidyl peptidase-4 inhibitors. Prior to using the On Time discussion tool, only 23% of individuals with diabetes were judged as likely (16%) or extremely likely (7%) willing to initiate insulin. The leading barriers to initiating insulin were apprehension toward needles/injections (59%), belief that insulin was complicated (56%), and psychological insulin resistance (45%). After using the On Time discussion tool, participants’ perceived willingness to initiate insulin increased (likely: 34%, extremely likely: 28%). Initiation of insulin was planned in 77% of participating individuals. The evaluation questionnaire was completed by 149 HCPs (76.4%), and showed that the discussion tool was perceived to help HCPs address insulin-related barriers (82%), positively impacted their practice (79%), and improved their approach when discussing insulin initiation with individuals with diabetes (76%). Identifying the barriers to initiating insulin and providing educational interventions to address them may help to improve insulin acceptance. Disclosure J. Gilbert: Other Relationship; Self; AstraZeneca, Boehringer Ingelheim GmbH, Eli Lilly and Company, Merck & Co., Inc., Novo Nordisk Inc., Janssen Pharmaceuticals, Inc., Sanofi. G. MacNeill: Consultant; Self; Becton, Dickinson and Company. Advisory Panel; Self; Janssen Pharmaceuticals, Inc., Eli Lilly and Company, Novo Nordisk Inc.. Consultant; Self; Sanofi. E.M. Cooke: Other Relationship; Self; Abbott. Speaker's Bureau; Self; Becton, Dickinson and Company, LifeScan Canada. Other Relationship; Self; LifeScan Canada. Speaker's Bureau; Self; Merck & Co., Inc.. Advisory Panel; Self; Sanofi. Speaker's Bureau; Self; Sanofi. Other Relationship; Self; Sanofi, mdBriefCase Group.P. Filteau: None. M. Vallis: Speaker's Bureau; Self; Novo Nordisk A/S. Advisory Panel; Self; Novo Nordisk Inc.. Speaker's Bureau; Self; AbbVie Inc.. Advisory Panel; Self; Valeant Pharmaceuticals International, Inc.. Speaker's Bureau; Self; Merck & Co., Inc.. Advisory Panel; Self; Sanofi. Speaker's Bureau; Self; Sanofi. M. Groleau: Employee; Self; Sanofi. P. Javadi: Employee; Self; Sanofi. C. Lebovics: Employee; Self; Sanofi.