Research article summary (published 30 Oct 2004):

Better long-term glycaemic control with the basal insulin glargine as compared with NPH in patients with Type 1 diabetes mellitus given meal-time lispro insulin.

Full Abstract

BACKGROUND: Glargine is a long-acting insulin analogue potentially more suitable than NPH insulin in intensive treatment of Type 1 diabetes mellitus (T1 DM), but no study has proven superiority. The aim of this study was to test superiority of glargine on long-term blood glucose (BG) as well as on responses to hypoglycaemia vs. NPH. METHODS: One hundred and twenty-one patients with T1 DM on intensive therapy on four times/day NPH and lispro insulin at each meal, were randomized to either continuation of NPH four times/day (n = 60), or once daily glargine at dinner-time (n = 61) for 1 year. Lispro insulin at meal-time was continued in both groups. In 11 patients from each group, responses to stepped hyperinsulinaemic-hypoglycaemia were measured before and after 1 year's treatment. RESULTS: Mean daily BG was lower with glargine [7.6 +/- 0.11 mmol/l (137 +/- 2 mg/dl)] vs. NPH [8.1 +/- 0.22 mmol/l (146 +/- 4 mg/dl)] (P < 0.05). HbA(1c) at 4 months did not change with NPH, but decreased with glargine (from 7.1 +/- 0.1 to 6.7 +/- 0.1%), and remained lower than NPH at 12 months (6.6 +/- 0.1%, P < 0.05 vs. NPH). Frequency of mild hypoglycaemia [self-assisted episodes, blood glucose < or = 4.0 mmol/l (72 mg/dl)] was lower with glargine vs. NPH (7.2 +/- 0.5 and 13.2 +/- 0.6 episodes/patient-month, P < 0.05). After 1 year, NPH treatment resulted in no change of responses to hypoglycaemia, whereas with glargine plasma glucose, thresholds and maximal responses of plasma adrenaline and symptoms to hypoglycaemia improved (P < 0.05). CONCLUSIONS: The simpler glargine regimen decreases the percentage of HbA(1c) and frequency of hypoglycaemia and improves responses to hypoglycaemia more than NPH. Thus, glargine appears more suitable than NPH as basal insulin for intensive treatment of T1 DM.

Author information

Author/s: Porcellati, F (F); Rossetti, P (P); Pampanelli, S (S); Fanelli, C G (CG); Torlone, E (E); Scionti, L (L); Perriello, G (G); Bolli, G B (GB);

Affiliation: Section of Internal Medicine, Endocrinology and Metabolism, University of Perugia, Via E. Dal Pozzo, I-06126 Perugia, Italy.

Journal and publication information

Publication Type: Clinical Trial; Comparative Study; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't

Journal: Diabetic medicine : a journal of the British Diabetic Association (Diabet Med), published in England. (Language: eng)

Reference: 2004-Nov; vol 21 (issue 11) : pp 1213-20

Dates: Created 2004/10/22; Completed 2005/01/24; Revised 2008/11/21;

PMID: 15498088, status: MEDLINE (last retrieval date: 2/18/2009, IMS Date: )

Sourced from the National Library of Medicine. Abstract text and other information may be subject to copyright.

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MeSH headings (categories)

This article was linked to the MESH Headings shown below.

Adult Blood Glucose - drug effects; metabolism Blood Glucose Self-Monitoring Cognition - drug effects Diabetes Mellitus, Type 1 - blood; drug therapy Drug Administration Schedule Drug Therapy, Combination Female

Female Hemoglobin A, Glycosylated - metabolism Humans Hypoglycemia - chemically induced Hypoglycemic Agents - adverse effects; therapeutic use Insulin - adverse effects; analogs & derivatives; therapeutic use Insulin, NPH - adverse effects; therapeutic use Male

Associated Chemicals: Blood Glucose (0) ; Hemoglobin A, Glycosylated (0) ; Hypoglycemic Agents (0) ; glargine (0) ; Insulin (11061-68-0) ; insulin LISPRO (133107-64-9) ; Insulin, NPH (53027-39-7)

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