A comparative study of insulin lispro and human regular insulin in patients with type 2 diabetes mellitus and secondary failure of oral hypoglycemic agents

Objective: To compare the effects of insulin lispro (LP) and human regular insulin (HR) when given twice daily with NPH insulin on glycemic control (H bA(1c)), daily blood glucose profiles and rates of hypoglycemia in patients with type 2 diabetes mellitus after failure to respond to sulfonylurea dru gs. Research design and methods: A 5.5-month randomized, open-label, parallel s tudy of 148 patients receiving either LP (n = 70) or HR (n = 78). Eight-poi nt blood glucose profiles and HbA(1c) measurements were collected at baseli ne, 1.5, 3.5 and 5.5 months. Results: Two-hour post-breakfast and 2-hour post-supper blood glucose level s (means [and standard errors]) were significantly lower for LP than for HR at the end point (9.5 [0.4] mmol/L v. 10.9 [0.4] mmol/L and 8.4 [0.4] mmol /L v. 9.7 [0.4] mmol/L, respectively, p = 0.02 in both cases). HbA(1c) impr oved from 10.5% (0.2%) (LP) and 10.3% (0.2%) (HR) to 8.0% (0.1%). Hypoglyce mia rates were similar during the day; however, there was an overnight tren d to reduced rates with LP (0.08 [0.03] episodes/30 d v. 0.16 [0.04] episod es/ 30 d, p = 0.057). Quality-of life assessment showed significant improve ment (p < 0.05) in the diabetes-related worry scale for LP subjects whereas HR subjects slightly worsened. Conclusions: With traditional twice-daily insulin administration algorithms , LP improves 2-hour postprandial glucose levels, quality of life and overn ight hypoglycemia rates while delivering an equivalent level of glycemic co ntrol (HbA(1c)) compared with HR to insulin-naive patients with type 2 diab etes who require insulin.