TAKE CONTROL, a 24-week, multicenter, randomized, open-label, parallel-group study, evaluated self- vs. physician-led titration of Gla-300 in people with T2DM. Efficacy and safety outcomes in people <65 years vs. ≥65 years were assessed. Baseline HbA1c and fasting SMPG were comparable; in the older and younger groups, HbA1c (p=0.46 and p=0.29) and fasting SMPG (p=0.56 and p=0.15) reductions were similar between self- vs. physician-led titration. Attainment of the fasting SMPG target (80-130 mg/dL) without confirmed (<54 mg/dL) or severe hypoglycemia was slightly higher in older people; differences in self- vs. physician-led titration were not significant in older or younger groups (p=0.19 and p=0.05). Incidences of hypoglycemia at any time of day (24 h) appeared slightly higher in the ≥65 years, physician-led group. There was no evidence of heterogeneity of effect of self- vs. physician-led titration on hypoglycemia (p>0.05). Adverse events were similar in each group. Self-titration of Gla-300 resulted in similar glycemic target achievement to physician-led titration, without an increased risk of hypoglycemia, irrespective of age. There was a trend for more people to reach fasting SMPG targets without hypoglycemia with self- vs. physician-led titration, including those ≥65 years.
K. Strojek: Research Support; Self; AstraZeneca. Other Relationship; Self; Sanofi-Aventis, Novo Nordisk A/S. Speaker's Bureau; Self; Servier, Eli Lilly and Company, MSD K.K., Boehringer Ingelheim GmbH. Research Support; Self; Pfizer Inc., Amgen Inc.. Speaker's Bureau; Self; Janssen Pharmaceuticals, Inc. G. Bigot: Employee; Self; Sanofi. Stock/Shareholder; Self; Sanofi. M. Bonnemaire: Employee; Self; Sanofi. Stock/Shareholder; Self; Sanofi. E. Delgado: Advisory Panel; Self; AstraZeneca. Speaker's Bureau; Self; AstraZeneca, Novo Nordisk A/S. Advisory Panel; Self; Sanofi-Aventis. Speaker's Bureau; Self; Sanofi-Aventis. Research Support; Self; Sanofi-Aventis. Speaker's Bureau; Self; Esteve, Boehringer Ingelheim Pharmaceuticals, Inc., Janssen Pharmaceuticals, Inc.. Advisory Panel; Self; Abbott. Speaker's Bureau; Self; Lilly. Research Support; Self; Menarini Group. V. Donicova: None. M. Kvapil: None. N. Papanas: None. L. Popescu: Employee; Self; Sanofi. Stock/Shareholder; Self; Sanofi. R. Ritzel: Speaker's Bureau; Self; AstraZeneca. Consultant; Self; Novo Nordisk A/S. Speaker's Bureau; Self; Novo Nordisk A/S. Consultant; Self; Sanofi. Speaker's Bureau; Self; Sanofi. Consultant; Self; Servier. Speaker's Bureau; Self; Bristol-Myers Squibb Company, Merck Sharp & Dohme Corp., Boehringer Ingelheim GmbH, Eli Lilly and Company, Novartis Pharmaceuticals Corporation. B. Schultes: Advisory Panel; Self; Novo Nordisk A/S, Sanofi, AstraZeneca, Eli Lilly and Company, Bayer AG, Boehringer Ingelheim GmbH. Speaker's Bureau; Self; Sanofi, Eli Lilly and Company, MSD K.K., Bayer AG, Boehringer Ingelheim GmbH. L. Duvnjak: None.