Therapy after single oral agent failure: adding a second oral agent or an insulin mixture?

Aim: to compare the glycemic response to an insulin lispro mixture (25% insulin lispro and 75% NPL) twice daily plus metformin (Mix25+M) with glibenclamide plus metformin (G+M), in patients with type 2 diabetes inadequately controlled with a single oral agent. Methods: 597 patients treated in a randomized, open-label, 16-week parallel study. Variables evaluated: hemoglobin A1C (A1C) , patient symptoms, hypoglycemia rate (episodes/patient/30 days), and incidence (% patients experiencing ≥1 episode). For a subset of patients ( N=120), fasting, 1-h, and 2-h postprandial plasma glucose (FPG, 1-h ppPG, 2-h ppPG) in response to a standardized test meal (STM) and self-monitored blood glucose (BG) profiles were measured. Results: improved A1C at endpoint for both groups, and A1C changes from baseline to endpoint were not significantly different between treatments (Mix25+M, −1.87±1.35% vs. G+M, −1.98±1.28%; p=0.288). Among patients completing STM; endpoint 2-h ppPG was significantly lower with Mix25+M (9.05±3.32 mmol/l vs. 12.31±3.65 mmol/l; p