Aim: To investigate whether the addition of a single bolus of insulin glulisine (glulisine), administered at either breakfast or main mealtime, in combination with basal insulin glargine (glargine) and oral antidiabetic drugs (OADs), provides equivalent glycaemic control in patients with type 2 diabetes, irrespective of the time of glulisine injection.
Methods: A national, multicentre, randomized, open-label, parallel-group study of 393 patients with type 2 diabetes who were suboptimally controlled [haemoglobin A(1c) (HbA(1c)) > 6.5-9.0% and fasting blood glucose (BG) <or=6.7 mmol/l] on their previous glargine and OAD regimen. A single injection of glulisine was added, either at breakfast or at main mealtime, to their existing therapy.
Results: The per-protocol group (n = 316) showed improved HbA(1c) (baseline vs. end-point) in the breakfast (7.4 vs. 7.0%; p < 0.0001) and main mealtime groups (7.3 vs. 6.9%; p < 0.0001). Glulisine given at breakfast was equally effective in controlling HbA(1c) as glulisine given at the main mealtime [adjusted HbA(1c) mean difference (95% confidence interval): 0.0481% (-0.115 to 0.211); p < 0.0001 for equivalence]. Overall, 30.7% of patients achieved HbA(1c)<or=6.5% at end-point but slightly more patients met this target in the main mealtime group vs. the breakfast group (33.8 vs. 27.8%; p = NS). This trend continued and was more marked when considering only those patients with HbA(1c) >7.0% at baseline and who reached HbA(1c)<or=7.0% at end-point (44.1% overall), with 52.2 and 36.5% for main mealtime and breakfast groups, respectively (p = 0.028). Most postprandial BG values improved within each group, while the number of hypoglycaemias was low and comparable between the two treatment groups.
Conclusions: A single bolus of glulisine, added to glargine and OADs, resulted in significantly improved HbA(1c) levels, irrespective of whether glulisine was administered at breakfast or at main mealtime. These results may represent a simplified and effective approach to treatment intensification in type 2 diabetes patients.