Reduced frequency of severe hypoglycemia and coma in well-controlled IDDM patients treated with insulin lispro. The Benelux-UK Insulin Lispro Study Group.
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.


METHODS
This was an open, randomized, 6-month crossover study of 199 IDDM patients. Glycemic control was evaluated by HbA1c, 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
HbA1c remained constant at approximately 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.
Holleman
F
F
Department of Internal Medicine, Diakonessenhuis, Utrecht, The Netherlands. fhollema@worldonline.nl
Schmitt
H
H
Rottiers
R
R
Rees
A
A
Symanowski
S
S
Anderson
J H
JH
D000328:Adult; D001786:Blood Glucose / Q000032:analysis* / Q000187:drug effects; D015190:Blood Glucose Self-Monitoring / Q000706:statistics & numerical data; D002940:Circadian Rhythm / Q000187:drug effects / Q000502:physiology; D003128:Coma / Q000453:epidemiology / Q000517:prevention & control; D018592:Cross-Over Studies; D003922:Diabetes Mellitus, Type 1 / Q000097:blood / Q000150:complications / Q000188:drug therapy*; D005260:Female; D006442:Glycated Hemoglobin / Q000032:analysis; D006801:Humans; D007003:Hypoglycemia / Q000188:drug therapy / Q000453:epidemiology* / Q000517:prevention & control; D007004:Hypoglycemic Agents / Q000627:therapeutic use*; D015994:Incidence; D007328:Insulin / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use; D061268:Insulin Lispro; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011788:Quality of Life
D001786:Blood Glucose; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D007328:Insulin; D061268:Insulin Lispro