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Mealtime Treatment With Insulin Analog Improves Postprandial Hyperglycemia and Hypoglycemia in Patients With Non-Insulin-Dependent Diabetes Mellitus

James H. Anderson Jr, MD; Rocco L. Brunelle, MS; Patrick Keohane, MD; Veikko A. Koivisto, MD; Michael E. Trautmann, MD; Louis Vignati, MD; Richard DiMarchi, PhD
Arch Intern Med. 1997;157(11):1249-1255. doi:10.1001/archinte.1997.00440320157015.
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Background:  Insulin lispro is an insulin analog that was recently developed particularly for a mealtime therapy. It has a fast absorption rate and short duration of action. The efficacy of insulin lispro in the clinical therapy of patients with non-insulin-dependent diabetes mellitus (NIDDM) has not been tested.

Objectives:  To compare insulin lispro and human regular insulin in the mealtime treatment of patients with NIDDM.

Methods:  A 6-month, randomized, multinational (16 countries), multicenter (80 sites) clinical trial with an open-label, crossover design was performed in 722 patients with NIDDM. Insulin lispro was injected immediately before and human regular insulin 30 to 45 minutes before the meal.

Results:  Throughout the study, the postprandial rise in serum glucose levels was significantly lower during insulin lispro than human regular insulin treatment. At end point the rise (mean ± SEM) in serum glucose levels was 30% lower at 1 hour (2.6±0.1 mmol/L [46.8±1.8 mg/ dL] for lispro vs 3.7±0.1 mmol/L [66.6±1.8 mg/dL] for human regular insulin) and 53% lower 2 hours after the test meal (1.4±0.1 mmol/L [25.2±1.8 mg/dL] for lispro vs 3.0±0.1 mmol/L [54.0±1.8 mg/dL] for human regular insulin) with insulin lispro compared with human regular insulin therapy (P<.001 for both intervals). During insulin lispro therapy the rate of hypoglycemia overall (P=.01) and overnight (P<.001) was lower and the number of asymptomatic hypoglycemic episodes was smaller (P=.03) than during human regular insulin therapy. Associated with a similar 13% increase (P<.001) in the total daily insulin dose, the glycosylated hemoglobin level decreased (P<.001) equally in both treatment groups. Serum lipid and lipoprotein levels remained unchanged. There were no differences in the adverse events between the 2 treatment groups.

Conclusions:  Compared with human regular insulin therapy, mealtime therapy with insulin lispro reduced postprandial hyperglycemia and may decrease the rate of mild hypoglycemic episodes in patients with NIDDM.Arch Intern Med. 1997;157:1249-1255

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