Abstract

The prospective observational Toujeo-Neo study investigated effects of switching to Gla-300 in 1,217 pts with T2DM, uncontrolled (A1c 7.5-10%) on another BI plus oral therapy plus prandial IT (BOTplus), or basal-bolus therapy (BBT) in daily clinical practice in Germany. Primary endpoint (EP) was duration of response (fasting plasma glucose (FPG) ≤110 mg/dL or A1c ≤ predefined individual target). Secondary EPs included changes in A1c, FPG, body weight (BW) and insulin doses, hypoglycemia incidences and safety. Here we report on pts with 12 months results available (n=798). Pts baseline characteristics, efficacy and hypoglycemia EPs are shown in Table 1. Main prev. BI was insulin glargine 100 U/mL (41.2%), most common oral therapy was metformin ± DPP-4 inhibitor (52.9%). At 12 months, proportion of pts at A1c target in BBT (n=446) was highest in pts previously on NPH insulin (n=84; 45.2%). Pts on BOTplus (n=82) achieved a greater A1c reduction (-0.71% vs. -0.53%) and higher A1c (48.8 vs. 38.4%) and FPG (22.0 vs. 17.7%) response rates than pts on BBT. Hypoglycemia rates were low and did not change significantly despite A1c reduction. BW remained stable. In conclusion, switching the BI in BOTplus or BBT to Gla-300 allowed uncontrolled T2DM pts to reduce their A1c by 0.56% w/o impact on hypoglycemia risk and minor BI dose changes. Disclosure S. Pscherer: Advisory Panel; Self; Sanofi-Aventis Deutschland GmbH. A. Fritsche: Advisory Panel; Self; Sanofi-Aventis Deutschland GmbH, Novo Nordisk A/S, Eli Lilly and Company, Boehringer Ingelheim GmbH. H. Anderten: Advisory Panel; Self; Sanofi-Aventis Deutschland GmbH, Merck Sharp & Dohme Corp.. Speaker's Bureau; Self; Sanofi-Aventis Deutschland GmbH, Merck Sharp & Dohme Corp., Eli Lilly and Company, Boehringer Ingelheim GmbH, Pfizer Inc., AstraZeneca, GlaxoSmithKline plc., Novartis AG, Novo Nordisk A/S, Takeda. K. Pegelow: Employee; Self; Sanofi-Aventis Deutschland GmbH. J. Seufert: Speaker's Bureau; Self; AstraZeneca, Berlin-Chemie AG, Boehringer Ingelheim GmbH. Research Support; Self; Boehringer Ingelheim GmbH. Advisory Panel; Self; Boehringer Ingelheim GmbH, GI Dynamics Inc.. Research Support; Self; GI Dynamics Inc., GlaxoSmithKline plc., Intarcia Therapeutics, Inc., Ipsen Biopharmaceuticals, Inc., Janssen Pharmaceuticals, Inc.. Speaker's Bureau; Self; Janssen Pharmaceuticals, Inc.. Advisory Panel; Self; Janssen Pharmaceuticals, Inc.. Speaker's Bureau; Self; Eli Lilly and Company, Merck Sharp & Dohme Corp., Novartis Pharmaceuticals Corporation. Research Support; Self; Novartis Pharmaceuticals Corporation. Advisory Panel; Self; Novo Nordisk A/S. Speaker's Bureau; Self; Novo Nordisk A/S. Research Support; Self; Novo Nordisk A/S. Speaker's Bureau; Self; Sanofi-Aventis Deutschland GmbH. Advisory Panel; Self; Sanofi-Aventis Deutschland GmbH. Research Support; Self; Sanofi-Aventis Deutschland GmbH. Advisory Panel; Self; Sanofi. Research Support; Self; Ypsomed AG. M. Pfohl: Advisory Panel; Self; Eli Lilly and Company, Novo Nordisk A/S, Sanofi. Speaker's Bureau; Self; Sanofi.

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