Τίτλος:
Take Control: A randomized trial evaluating the efficacy and safety of self- versus physician-managed titration of insulin glargine 300 U/mL in patients with uncontrolled type 2 diabetes
Γλώσσες Τεκμηρίου:
Αγγλικά
Περίληψη:
Aim: To compare the efficacy and safety of self- versus physician-managed titration of insulin glargine 300 U/mL (Gla-300) in people with inadequately controlled type 2 diabetes. Methods: Take Control (EudraCT number: 2015-001626-42) was a 24-week, multi-national, open-label, controlled, two-arm, parallel-group study in insulin-naïve and pre-treated participants, randomized 1:1 to a self- or physician-managed titration of Gla-300. The fasting self-monitored plasma glucose (SMPG) target was 4.4 to 7.2 mmol/L. The primary outcome was non-inferiority of glycated haemoglobin (HbA1c) change from baseline to week 24. Secondary outcomes included SMPG target achievement without hypoglycaemia, hypoglycaemia incidence, adverse events and participant-reported outcomes (PROs). Results: At week 24, the least squares (LS) mean HbA1c reduction was 0.97% (10.6 mmol/mol) and 0.84% (9.2 mmol/mol) in the self- and physician-managed groups, respectively, with an LS mean difference of −0.13% [95% confidence interval −0.2619 to −0.0004] (–1.4 mmol/mol [–2.863 to –0.004]), demonstrating non-inferiority (P < 0.0001) and superiority (P = 0.0247) of self- versus physician-managed titration. Significantly more of the self- than physician-managed group achieved SMPG target without hypoglycaemia (67% vs 58%; P = 0.0187). Overall, hypoglycaemia incidence was similar in each group. No safety concerns were reported. In both groups, similar PRO improvements were observed for distress related to diabetes disease burden and for confidence in diabetes self-management, with even more individuals achieving a clinically relevant reduction in emotional burden and fewer individuals with high emotional burden in the self-managed group. Conclusions: Self-managed titration of Gla-300 was superior to physician-managed titration in terms of HbA1c reduction, accompanied by similar total PRO scores, with a clinically relevant reduction in emotional burden, and similar hypoglycaemia frequency. © 2019 John Wiley & Sons Ltd
Συγγραφείς:
Russell-Jones, D.
Dauchy, A.
Delgado, E.
Dimitriadis, G.
Frandsen, H.A.
Popescu, L.
Schultes, B.
Strojek, K.
Bonnemaire, M.
Roborel de Climens, A.
Davies, M.
Περιοδικό:
Diabetes, Obesity and Metabolism
Εκδότης:
Wiley-Blackwell Publishing Ltd
Λέξεις-κλειδιά:
glucagon like peptide 1 receptor agonist; hemoglobin A1c; insulin detemir; insulin glargine; isophane insulin; metformin; sodium glucose cotransporter 1 inhibitor; sulfonylurea derivative; antidiabetic agent; glycosylated hemoglobin; insulin glargine, adult; adverse event; Article; controlled study; diabetes control; disease burden; drug dose titration; drug efficacy; drug safety; emotion; female; glucose blood level; hemoglobin blood level; human; hypoglycemia; incidence; intermethod comparison; major clinical study; male; middle aged; multicenter study; non insulin dependent diabetes mellitus; open study; parallel design; patient attitude; patient-reported outcome; physician; randomized controlled trial; scoring system; self care; aged; hypoglycemia; non insulin dependent diabetes mellitus; self care, Aged; Blood Glucose; Diabetes Mellitus, Type 2; Female; Glycated Hemoglobin A; Humans; Hypoglycemia; Hypoglycemic Agents; Insulin Glargine; Male; Middle Aged; Self-Management
