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甘精胰岛素与地特胰岛素比较

A randomised, 52-week, treat-to-target trial comparinginsulin detemir with insulin glargine when administeredas add-on to glucose-lowering drugs in insulin-naive peoplewith type 2 diabetes

  Abstract

Aims/hypothesis

This 52-week multinational, randomised,open-label, parallel-group, non-inferiority trial comparedclinical outcomes following supplementation of oral glucose-lowering drugs with basal insulin analogues detemirand glargine in type 2 diabetic patients.

Methods

Insulin-naive adults (n=582, HbA1c 7.5–10.0%,BMI≤40.0 kg/m2) were randomised 1:1 to receive insulindetemir or glargine once daily (evening) actively titrated totarget fasting plasma glucose (FPG)≤6.0 mmol/l. Anadditional morning insulin detemir dose was permitted ifpre-dinner plasma glucose (PG) was >7.0 mmol/l after achieving FPG<7.0 mmol/l. Due to labelling restrictions,no second glargine dose was allowed.

Results

Baseline HbA1c decreased from 8.6 to 7.2 and7.1% (NS) with detemir and glargine, respectively. FPGimproved from 10.8 to 7.1 and 7.0 mmol/l (NS), respectively.With detemir, 45% of participants completed thestudy on once daily dosing and 55% on twice daily dosing,with no difference in HbA1c. Overall, 52% of participantsachieved HbA1c≤7.0%: 33% (detemir) and 35% (glargine)without hypoglycaemia. Within-participant variability forself-monitored FPG and pre-dinner PG did not differ byinsulin treatment, nor did the relative risk of overall ornocturnal hypoglycaemia. Modest reductions in weight gainwere seen with detemir vs glargine in completers (3.0 vs3.9 kg, p=0.01) and in the intention-to-treat population (2.7vs 3.5 kg, p=0.03), primarily related to completers on oncedailydetemir. Mean daily detemir dose was higher (0.78 U/kg[0.52 with once daily dosing, 1.00 U/kg with twice dailydosing]) than glargine (0.44 IU/kg). Injection site reactionswere more frequent with detemir (4.5 vs 1.4%).

Conclusions/interpretation

Supplementation of oral agentswith detemir or glargine achieves clinically importantimprovements in glycaemic control with low risk ofhypoglycaemia. Non-inferiority was demonstrated for detemirusing higher insulin doses (mainly patients on twice daily dosing); weight gain was somewhat reduced withonce daily insulin detemir.

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