Adding fast-acting insulin aspart to basal insulin significantly improved glycaemic control in patients with type 2 diabetes: A randomized, 18-week, open-label, phase 3 trial (onset 3).

ABSTRACT: To confirm glycaemic control superiority of mealtime fast-acting insulin aspart (faster aspart) in a basal-bolus (BB) regimen vs basal-only insulin.In this open-label, randomized, 18-week trial (51 sites; 6 countries), adults (n?=?236) with inadequately controlled type 2 diabetes (T2D; mean glycosylated haemoglobin [HbA1c]?±?SD: 7.9%?±?0.7% [63.1?±?7.5?mmol/mol]) receiving basal insulin and oral antidiabetic drugs underwent 8-week optimization of prior once-daily basal insulin followed by randomization 1:1 to either a BB regimen with faster aspart (n?=?116) or continuation of once-daily basal insulin (n?=?120), both with metformin. Primary endpoint was HbA1c change from baseline after 18?weeks of treatment. Secondary endpoints included: postprandial plasma glucose (PPG) change and overall PPG increment (all meals); weight; treatment-emergent adverse events; hypoglycaemic episodes.HbA1c decreased from 7.9% (63.2?mmol/mol) to 6.8% (50.7?mmol/mol; BB group) and from 7.9% (63.2?mmol/mol) to 7.7% (60.7?mmol/mol; basal-only group); estimated treatment difference [95% confidence interval] -0.94% [-1.17; -0.72]; -10.3?mmol/mol [-12.8; -7.8]; P ?

SUBMITTER: Rodbard HW 

PROVIDER: S-EPMC5637905 | biostudies-other | 2017 Oct

REPOSITORIES: biostudies-other