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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.

Abstract
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

Author Affiliations
From the Lilly Research Laboratories, Indianapolis, Ind (Drs Anderson, Keohane, Trautmann, Vignati, and DiMarchi and Mr Brunelle), and the Department of Medicine, Helsinki University Hospital, Helsinki, Finland (Dr Koivisto). A list of the clinical investigators of the Multicenter Insulin Lispro Study Group appears on page 1251.

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