A STEPWISE APPROACH TO INSULIN THERAPY IN PATIENTS WITH TYPE 2 DIABETES FAILING BASAL INSULIN TREATMENT

 

ABSTRACT

 

 

Basal-prandial insulin regimens typically use rapid-acting insulin before each meal. Because of patient reluctance to implement a 4-injection regimen, we determined if 1 or 2 preprandial injections before the meals of greatest glycemic impact can be as effective as 3 preprandial injections.

 

 

Open-label, parallel-group, 1:1:1 randomized study of adults with type 2 diabetes on oral antidiabetic drugs with glycated hemoglobin (A1C) ≥8.0%. Following a 14-week run-in with insulin glargine, subjects with an A1C of >7.0% were randomized to once-, twice-, or 3-times daily insulin glulisine for 24 weeks. Changes in A1C from randomization to study end; percentage achieving an A1C of <7.0%; changes in A1C, fasting glucose concentrations, and weight at individual study points; and safety (adverse events and hypoglycemia) were assessed throughout the study.

 

 

Fifty-four percent of those completing the run-in phase with insulin glargine were randomized. During the randomization phase, A1C reductions with insulin glulisine once- and twice- daily were non-inferior to insulin glulisine 3 times daily (CI:-0.39, 0.36 and -0.30, 0.43; P>0.5 for both). However, more subjects met the target A1C with 3 preprandial injections (46%) than with 2 (33%) or 1 (30%) injection. Severe hypoglycemia occurred in twice as many subjects receiving 3 preprandial injections (16%) compared with those receiving 2 (8%) and 1 (7%) but these differences did not reach statistical significance.

 

 

This study provides evidence that initiation of prandial insulin in a simplified stepwise approach is an effective alternative to the current routine 3 preprandial injection basalbolus approach.