title: A comparison of human ultralente- and lente-based twice-daily injection regimens.
abstract: The problem of fasting hyperglycaemia remains unresolved on currently used twice-daily injection regimens. Human ultralente insulin is of longer duration than human lente and differs from it only in the nature of the zinc-insulin complex. In a 6-month double-blind crossover study these insulins were compared in 66 patients who were randomized to human ultralente or human lente insulin given together with human soluble insulin in a twice-daily injection regimen. Patients were seen monthly and crossed over after 3 months treatment. Fasting blood glucose concentrations on the ultralente regimen were considerably lower than on the lente regimen, the difference being statistically significant (6.6 +/- 0.5 vs 8.2 +/- 0.5 mmol l-1, p less than 0.05), but only present in those patients with fasting concentrations below the median. Glycosylated haemoglobin was identical on both regimens (9.3 +/- 0.2%). The evening ultralente dose was slightly but significantly lower than the evening lente dose (14.9 +/- 0.8 vs 15.5 +/- 0.8 U, p less than 0.05) thus endorsing the lowering effect of ultralente on the fasting blood glucose concentration. However, the incidence of serious hypoglycaemic events was higher on the ultralente regimen (0.38 +/- 0.10 vs 0.09 +/- 0.04 events per patient-month, p less than 0.02), the majority of nocturnal events occurring between 0500 h and breakfast. We conclude that ultralente insulin can give an improved fasting blood glucose concentration but that in those patients with more marked fasting hyperglycaemia or with a nocturnal hypoglycaemia problem it offers no clinical advantage over human lente insulin in a twice-daily injection regimen.
authors.affiliation: Department of Medicine, University of Newcastle upon Tyne, UK.
authors.forename: F K
authors.initials: FK
authors.lastname: Tunbridge
authors.forename: A
authors.initials: A
authors.lastname: Newens
authors.forename: P D
authors.initials: PD
authors.lastname: Home
authors.forename: S N
authors.initials: SN
authors.lastname: Davis
authors.forename: M
authors.initials: M
authors.lastname: Murphy
authors.forename: J M
authors.initials: JM
authors.lastname: Burrin
authors.forename: K G
authors.initials: KG
authors.lastname: Alberti
authors.forename: I
authors.initials: I
authors.lastname: Jensen
mesh_terms: D000328:Adult; D001786:Blood Glucose / Q000032:analysis; D015190:Blood Glucose Self-Monitoring; D002096:C-Peptide / Q000097:blood; D003692:Delayed-Action Preparations; D003922:Diabetes Mellitus, Type 1 / Q000097:blood / Q000188:drug therapy*; D004334:Drug Administration Schedule; D005260:Female; D006442:Glycated Hemoglobin / Q000032:analysis; D006801:Humans; D007003:Hypoglycemia / Q000209:etiology; D007279:Injections, Subcutaneous; D049528:Insulin, Long-Acting / Q000008:administration & dosage* / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000627:therapeutic use
chemical_list: D001786:Blood Glucose; D002096:C-Peptide; D003692:Delayed-Action Preparations; D006442:Glycated Hemoglobin; D049528:Insulin, Long-Acting; D011994:Recombinant Proteins