Higher versus standard starting dose of insulin glargine 100?U/mL in overweight or obese Chinese patients with type 2 diabetes: Results of a multicentre, open-label, randomized controlled trial (BEYOND VII).

ABSTRACT: AIM:To determine the safety of a higher starting dose of basal insulin in overweight/obese patients with type 2 diabetes (T2D). MATERIALS AND METHODS:This 16-week, randomized, multicentre, open-label trial enrolled adults with T2D (body mass index 25-40?kg/m2 ) and suboptimal glycaemic control (glycated haemoglobin [HbA1c] 7.5-11.0% [58-97 mmol/mol] and fasting plasma glucose [FPG] >9.0?mmol/L) with two to three oral anti-hyperglycaemic drugs at 51 centres in China. Patients were randomized (1:1) to a higher (0.3?U/kg) or standard (0.2?U/kg) starting dose of insulin glargine 100?U/mL, which was then titrated to achieve a self-monitored fasting blood glucose (FBG) of 4.4 to 5.6?mmol/L. The primary endpoint was the percentage of patients with ?1 episode of overall confirmed hypoglycaemia (?3.9?mmol/L or severe). RESULTS:At the end of study (n = 866), 11.0% patients treated with the 0.3?U/kg starting insulin dose experienced overall confirmed hypoglycaemia versus 8.6% of patients treated with 0.2?U/kg (estimated difference 2.1%, 95% confidence interval?-?1.68, 5.89). The proportions of patients with symptomatic (9.8% vs 7.0%; P = 0.128) and nocturnal hypoglycaemia (2.7% vs 1.2%; P = 0.102) were similar in the two groups. There were no events of severe hypoglycaemia or FBG <3.0?mmol/L during the 16-week treatment, and achievement of HbA1c <7.0% (53 mmol/mol) (37.1% vs 37.1%) or FPG <5.6?mmol/L (15.9% vs 16.3%), <6.1?mmol/L (27.6% vs 26.1%), or?

SUBMITTER: Ji L 

PROVIDER: S-EPMC7187195 | biostudies-literature | 2020 May

REPOSITORIES: biostudies-literature