Abstract

OBJECTIVE: Compare two analog insulin therapies (prandial premixed therapy [PPT] vs. basal bolus therapy [BBT]) in type 2 diabetes patients previously treated with insulin glargine (≥30 units/d) + oral agents, with the aim of demonstrating non-inferiority of PPT to BBT.

RESEARCH DESIGN AND METHODS: Patients were randomized to PPT (lispro mix 50/50; 50% insulin lispro protamine suspension [ILPS], 50% lispro; n=187) tid with meals or BBT (glargine at bedtime + mealtime lispro; n=187) in a 24-wk, multicenter, open-label, non-inferiority trial. Investigators could replace lispro mix 50/50 with lispro mix 75/25 at the evening meal if fasting PG target was unachievable.

RESULTS: Baseline A1C was similar (PPT 8.8%, BBT 8.9%, P=0.598). At wk 24, A1C was lower with BBT (6.78 vs. 6.95%, P=0.021). A1C was reduced significantly from baseline for both therapies (P<0.0001). The difference in A1C change from baseline to endpoint (BBT minus PPT) was -0.22% (90% CI: -0.38%;-0.07%). Non-inferiority of PPT to BBT was not demonstrated based on the pre-specified non-inferiority margin of 0.3%. Percent of patients achieving target A1C <7.0% (PPT vs. BBT) was 54% vs. 69% (P=0.009) and for target ≤6.5% was 35% vs. 50% (P=0.01), but did not differ for target ≤6.0% or <7.5%. Rates of hypoglycemia were similar for both groups.

CONCLUSIONS: While non-inferiority of PPT to BBT was not demonstrated, findings on A1C reduction, % achieving A1C targets, hypoglycemia, and number of required injections should be considered in the individual decision-making process of advancing insulin replacement to PPT vs. BBT in type 2 diabetes.