Insulin lispro in the treatment of patients with type 2 diabetes mellitus after oral agent failure

This study assessed the safety profile and efficacy of a new combination th erapy (insulin lispro plus sulfonylurea) in patients with type 2 diabetes m ellitus experiencing secondary oral agent failure. A total of 423 patients were randomly assigned to 3 treatment groups: preprandial insulin lispro pl us sulfonylurea (L + S), bedtime neutral protamine Hagedorn (NPH) insulin p lus sulfonylurea (N + S), and preprandial insulin Lispro plus bedtime NPH i nsulin (L + N). Mean decreases in glycosylated hemoglobin from baseline wer e 1.60% +/- 1.27% for patients receiving L + S, 1.21% +/- 1.21% for those r eceiving N + S, and 1.40% +/- 1.46% for those receiving L + N (within treat ment, P < 0.001; for L + S vs N + S, P = 0.003). Fasting blood glucose leve l was higher in patients receiving L + S (171 +/- 46.5 mg/dL) or L + N (166 +/- 52.5 mg/dL) than in those receiving N + S (144 +/- 48.2 mg/dL) (P < 0. 001, for both comparisons). Conversely, postprandial blood glucose level wa s lower in patients receiving L + S (165 +/- 41.6 mg/dL) or L + N (165 +/- 46.3 mg/dL) than in those receiving N + S (213 +/- 58.3 mg/dL) (P < 0.001, for both comparisons). The overall rate of hypoglycemia (episodes per 30 da ys) was not statistically significant when the L + S, N + S, and L + N ther apies were compared (0.99 +/- 1.74 vs 0.87 +/- 2.31 vs 1.16 +/- 2.38, respe ctively). The rate of nocturnal hypoglycemia was lowest in the L + S group (0.00 +/- 0.00 vs 0.10 +/- 0.37 for the N + S group vs 0.15 +/- 0.54 for th e L + N group; P = 0.004). L + S, which has a safety profile equal to those of N + S and L + N, is an effective treatment for patients with type 2 dia betes who experience oral sulfonylurea agent failure. L + S offers an alter native to these established combination therapies in patients whose type 2 diabetes cannot be controlled with a sulfonylurea alone.