Twice‐daily pre‐mixed insulin rather than basal insulin therapy alone results in better overall glycaemic control in patients with Type 2 diabetes

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Abstract
Aims  To compare the glycaemic control of an insulin lispro mixture (25% insulin lispro and 75% NPL) twice daily in combination with metformin to that of once‐daily insulin glargine plus metformin in patients with Type 2 diabetes inadequately controlled with intermediate insulin, or insulin plus oral agent(s) combination therapy.Research design and methods  Ninety‐seven patients were randomized in a multicentre, open‐label, 32‐week crossover study. Primary variables evaluated: haemoglobin A1c (A1c), 2‐h post‐prandial blood glucose (BG), hypoglycaemia rate (episodes/patient/30 days), incidence (% patients experiencing ≥ 1 episode) of overall and nocturnal hypoglycaemia.Results  At endpoint, A1c was lower with the insulin lispro mixture plus metformin compared with glargine plus metformin (7.54% ± 0.87% vs. 8.14% ± 1.03%, P < 0.001). Change in A1c from baseline to endpoint was greater with the insulin lispro mixture plus metformin (−1.00% vs. −0.42%; P < 0.001). Two‐hour post‐prandial BG was lower after morning, midday, and evening meals (P < 0.001) during treatment with the insulin lispro mixture plus metformin. The fasting BG values were lower with glargine plus metformin (P = 0.007). Despite lower BG at 03.00 hours (P < 0.01), patients treated with the insulin lispro mixture plus metformin had a lower rate of nocturnal hypoglycaemia (0.14 ± 0.49 vs. 0.34 ± 0.85 episodes/patient/30 days; P = 0.002), although the overall hypoglycaemia rate was not different between treatments (0.61 ± 1.41 vs. 0.44 ± 1.07 episodes/patient/30 days; P = 0.477).Conclusion  In patients with Type 2 diabetes and inadequate glucose control while on insulin or insulin and oral agent(s) combination therapy, treatment with a twice‐daily insulin lispro mixture plus metformin, which targets both post‐prandial and pre‐meal BG, provided clinically significant improvements in A1c, significantly reduced post‐prandial BG after each meal, and reduced nocturnal hypoglycaemia as compared with once‐daily glargine plus metformin, a treatment that targets fasting BG.

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