Background As type 2 diabetes mellitus progresses, oral hypoglycaemic agents often fail to maintain blood glucosecontrol and insulin is needed. We investigated whether the addition of once-daily insulin glargine is non-inferior tothree-times daily prandial insulin lispro in overall glycaemic control in adults with inadequately controlled type 2diabetes mellitus taking oral hypoglycaemic agents.Methods In the 44-week, parallel, open study that was undertaken in 69 study sites across Europe and Australia,418 patients with type 2 diabetes mellitus that was inadequately controlled by oral hypoglycaemic agents wererandomly assigned to either insulin glargine taken once daily at the same time every day or to insulin lisproadministered three times per day. The primary objective was to compare the change in haemoglobin A1c from baselineto endpoint (week 44) between the two regimens. Randomisation was done with a central randomisation service.Analysis was per protocol. This study is registered with ClinicalTrials.gov, number NCT00311818.Findings 205 patients were randomly assigned to insulin glargine and 210 to insulin lispro. Mean haemoglobin A1cdecrease in the insulin glargine group was –1·7% (from 8·7% [SD 1·0] to 7·0% [0·7]) and –1·9% in the insulin lisprogroup (from 8·7% [1·0] to 6·8% [0·9]), which was within the predefi ned limit of 0·4% for non-inferiority(diff erence=0·157; 95% Cl –0·008 to 0·322). 106 (57%) patients reached haemoglobin A1c of 7% or less in the glarginegroup and 131 (69%) in the lispro group. In the glargine group, the fall in mean fasting blood glucose (–4·3 [SD 2·3]mmol/L vs –1·8 [2·3] mmol/L; p<0·0001) and nocturnal blood glucose (–3·3 [2·8] mmol/L vs –2·6 [2·9] mmol/L;p=0·0041) was better than it was in the insulin lispro group, whereas insulin lispro better controlled postprandialblood glucose throughout the day (p<0·0001). The incidence of hypoglycaemic events was less with insulin glarginethan with lispro (5·2 [95% CI 1·9–8·9] vs 24·0 [21–28] events per patient per year; p<0·0001). Respective mean weightgains were 3·01 (SD 4·33) kg and 3·54 (4·48) kg. The improvement of treatment satisfaction was greater for insulinglargine than for insulin lispro (mean diff erence 3·13; 95% CI 2·04–4·22).Interpretation A therapeutic regimen involving the addition of either basal or prandial insulin analogue is equallyeff ective in lowering haemoglobin A1c. We conclude that insulin glargine provides a simple and eff ective option that ismore satisfactory to patients than is lispro for early initiation of insulin therapy, since it was associated with a lowerrisk of hypoglycaemia, fewer injections, less blood glucose self monitoring, and greater patient satisfaction than wasinsulin lispro.
|Number of pages||11|
|Publication status||Published - 2008|