Reduced Frequency of Severe Hypoglycemia and Coma in Well-Controlled IDDM Patients Treated With Insulin Lispro

OBJECTIVE Several studies have suggested that use of the short-acting insulin analog, insulin lispro, in multiple injection therapy may reduce the risk of hypoglycemia in comparison with regular insulin. This effect might be more pronounced in well-controlled patients, since intensive treatment of IDDM increases the rate of severe hypoglycemic events. This study evaluated the effects of insulin lispro on glycemic control and hypoglycemia rates in well-controlled IDDM patients.

RESEARCH DESIGN AND METHODS This was an open, randomized, 6-month crossover study of 199 IDDM patients. Glycemic control was evaluated by HbA_1c, home blood glucose measurements, and rate and timing of hypoglycemic events. At the end of the study, patients completed an evaluation form regarding therapy-related quality of life.

RESULTS HbA_1c remained constant at ∼ 7.3% throughout the study. Meal-related glucose excursions were significantly lower with insulin lispro compared with regular insulin (mean −0.8 ± 1.7 vs. 1.1 ± 1.6 mmol/l, P < 0.001), as was the within-day variability (M value 27.7 ± 19.7 vs. 30.2 ± 23.1, P = 0.007). The incidence of severe hypoglycemic events (58 vs. 36, P = 0.037) including coma (16 vs. 3, P = 0.004) was significantly lower with insulin lispro than with regular insulin. Patients felt that insulin lispro increased flexibility and freedom of lifestyle.

CONCLUSIONS In well-controlled IDDM patients, insulin lispro is associated with a lower risk of severe hypoglycemia and coma.