Switching to Insulin Glargine 300 U/mL (Gla-300) Improves Glycemic Control and Reduces Nocturnal Hypoglycemia in Patients (Pts) with Type 2 Diabetes (T2DM) on Basal Insulin Supported Oral Therapy (BOT)

Abstract

The prospective observational TOP-2 study investigates the effects of switching pts with T2DM in Germany (n=1,662), Austria and Switzerland, who are uncontrolled (A1c 7.5-10%) on BOT with other basal insulins (BI) to Gla-300 in daily clinical practice. Primary endpoint (EP) is the proportion of pts achieving fasting plasma glucose (FPG) of ≤110 mg/dL after 6 and 12 months, respectively. Secondary EPs include changes in A1c, FPG, body weight (BW) and insulin dose, hypoglycemia incidence and safety. Here we report results of pts recruited at German sites with 12 months results available (n=679). Pts baseline characteristics, efficacy and hypoglycemia EPs are shown in Table 1. Main previous BI was insulin glargine 100 U/mL (Gla-100; 49.2%), most common oral therapy was metformin ± DPP-4 inhibitors (46.4%). At 12 months, proportions of pts at their FPG and A1c targets were 27.0% and 43.2%, respectively. Percentage of pts at FPG and A1c target was max in previous Gla-100 pts (29.3%) and insulin detemir pts (55.3%), respectively. Hypoglycemia rates were low with a trend of >70% reduction of nocturnal hypoglycemia incidence. BW remained stable. In conclusion, switching the BI in a BOT regimen to Gla-300 allowed uncontrolled T2DM pts to reduce their A1c by 0.81% with less nocturnal hypoglycemia and minor BI dose changes. Disclosure 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. 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. S. Pscherer: Advisory Panel; Self; Sanofi-Aventis Deutschland GmbH. M. Pfohl: Advisory Panel; Self; Eli Lilly and Company, Novo Nordisk A/S, Sanofi. Speaker's Bureau; Self; Sanofi.