Double-blind crossover trial of isophane (NPH)- and lente-based insulin regimens.
Isophane (NPH) and lente insulin preparations have been the basis of insulin-injection regimens for many decades but were never formally compared. After a 2-mo run-in period, 82 patients were randomized to NPH (Protaphane) or lente (Monotard) insulin preparations given together with Actrapid as a twice-daily injection regimen in a double-blind study. Patients were seen monthly and crossed over after 5 mo of treatment. Control as assessed by glycosylated hemoglobin (NPH 9.2 +/- 0.1%, lente 9.3 +/- 0.1%, mean +/- SE) and fructosamine (1.55 +/- 0.02 and 1.57 +/- 0.02 mM) concentrations was identical for the two regimens as were home-collected laboratory-measured fasting blood glucose (BG) (NPH 8.8 +/- 0.5 mM, lente 9.0 +/- 0.5 mM) and mean BG (8.2 +/- 0.3 and 7.6 +/- 0.3 mM) concentrations. For both regimens, the major control problem was the BG concentration before and after breakfast. Total insulin dosage was similar (NPH 56.3 +/- 0.6 U/day, lente 57.2 +/- 0.6 U/day) with no tendency for a difference in the evening intermediate-acting dose (NPH 17.0 +/- 0.3 U/day, lente 17.0 +/- 0.3 U/day) to counter fasting hyperglycemia. Serum lipid concentrations and body weight confirmed the equivalence of control. Hypoglycemic events were recorded in personal diaries and graded by predetermined criteria. Self-treated, relative-assisted, and hospital/doctor-treated hypoglycemic events did not differ in frequency. We conclude that lente- and NPH-based twice-daily human insulin regimens give indistinguishable metabolic control.
Tunbridge
F K
FK
Department of Medicine, University of Newcastle upon Tyne, UK.
Newens
A
A
Home
P D
PD
Davis
S N
SN
Murphy
M
M
Burrin
J M
JM
Alberti
K G
KG
Jensen
I
I
D000328:Adult; D001786:Blood Glucose / Q000032:analysis; D002784:Cholesterol / Q000097:blood; D002986:Clinical Trials as Topic; D003922:Diabetes Mellitus, Type 1 / Q000097:blood / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D019270:Fructosamine; D006442:Glycated Hemoglobin / Q000032:analysis; D006595:Hexosamines / Q000032:analysis; D006801:Humans; D007003:Hypoglycemia / Q000209:etiology; D007336:Insulin, Isophane / Q000627:therapeutic use*; D049528:Insulin, Long-Acting / Q000627:therapeutic use*; D008297:Male; D014280:Triglycerides / Q000097:blood
D001786:Blood Glucose; D002784:Cholesterol; D019270:Fructosamine; D006442:Glycated Hemoglobin; D006595:Hexosamines; D007336:Insulin, Isophane; D049528:Insulin, Long-Acting; D014280:Triglycerides