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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.
Diabet Med. 2004 Nov; 21(11):1213-20.DM

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.

Authors+Show Affiliations

Section of Internal Medicine, Endocrinology and Metabolism, University of Perugia, Via E. Dal Pozzo, I-06126 Perugia, Italy.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

15498088

Citation

Porcellati, F, et al. "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." Diabetic Medicine : a Journal of the British Diabetic Association, vol. 21, no. 11, 2004, pp. 1213-20.
Porcellati F, Rossetti P, Pampanelli S, et al. 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. Diabet Med. 2004;21(11):1213-20.
Porcellati, F., Rossetti, P., Pampanelli, S., Fanelli, C. G., Torlone, E., Scionti, L., Perriello, G., & Bolli, G. B. (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. Diabetic Medicine : a Journal of the British Diabetic Association, 21(11), 1213-20.
Porcellati F, et al. 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. Diabet Med. 2004;21(11):1213-20. PubMed PMID: 15498088.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Porcellati,F, AU - Rossetti,P, AU - Pampanelli,S, AU - Fanelli,C G, AU - Torlone,E, AU - Scionti,L, AU - Perriello,G, AU - Bolli,G B, PY - 2004/10/23/pubmed PY - 2005/1/26/medline PY - 2004/10/23/entrez SP - 1213 EP - 20 JF - Diabetic medicine : a journal of the British Diabetic Association JO - Diabet. Med. VL - 21 IS - 11 N2 - 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. SN - 0742-3071 UR - https://www.unboundmedicine.com/medline/citation/15498088/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_ L2 - http://ovidsp.ovid.com/ovidweb.cgi?T=JS&amp;PAGE=linkout&amp;SEARCH=15498088.ui DB - PRIME DP - Unbound Medicine ER -