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Improved glycaemic control with insulin glargine plus insulin lispro: a multicentre, randomized, cross-over trial in people with Type 1 diabetes.
Diabet Med. 2006 Mar; 23(3):285-92.DM

Abstract

AIMS

To compare blood glucose control using insulin glargine + insulin lispro with that on NPH insulin + unmodified human insulin in adults with Type 1 diabetes managed with a multiple injection regimen.

METHODS

In this 32-week, five-centre, two-way cross-over study, people with Type 1 diabetes (n = 56, baseline HbA1c 8.0 +/- 0.8%) were randomized to evening insulin glargine + mealtime insulin lispro or to NPH insulin (once- or twice-daily) + mealtime unmodified human insulin. Each 16-week period concluded with a 24-h inpatient plasma glucose profile.

RESULTS

HbA1c was lower with glargine + lispro than with NPH + human insulin [7.5 vs. 8.0%, difference -0.5 (95% CI -0.7, -0.3) %, P < 0.001]. This was confirmed by an 8% lower 24-h plasma glucose area under the curve (AUC) (187 vs. 203 mmol l(-1) h(-1), P = 0.037), a 24% reduction in plasma glucose AUC > 7.0 mmol/l1 (47 vs. 62 mmol l(-1) h(-1), P = 0.017) and a 15% lower post-prandial plasma glucose AUC (75 vs. 88 mmol l(-1) h(-1), P = 0.002). There was no reduction in night-time plasma glucose AUC or increase in plasma glucose area < 3.5 mmol/l. Monthly rate of nocturnal hypoglycaemia was reduced by 44% with glargine + lispro (0.66 vs. 1.18 episodes/month, P < 0.001).

CONCLUSIONS

Compared with NPH insulin + unmodified human insulin, the combination of insulin glargine with a rapid-acting insulin analogue as multiple-injection therapy for Type 1 diabetes improves overall glycaemic control as assessed by HbA1c and 24-h plasma glucose monitoring to a clinically significant degree, together with a reduction in nocturnal hypoglycaemia.

Authors+Show Affiliations

University of Newcastle upon Tyne, Newcastle upon Tyne, UK. s.g.ashwell@ncl.ac.ukNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

16492212

Citation

Ashwell, S G., et al. "Improved Glycaemic Control With Insulin Glargine Plus Insulin Lispro: a Multicentre, Randomized, Cross-over Trial in People With Type 1 Diabetes." Diabetic Medicine : a Journal of the British Diabetic Association, vol. 23, no. 3, 2006, pp. 285-92.
Ashwell SG, Amiel SA, Bilous RW, et al. Improved glycaemic control with insulin glargine plus insulin lispro: a multicentre, randomized, cross-over trial in people with Type 1 diabetes. Diabet Med. 2006;23(3):285-92.
Ashwell, S. G., Amiel, S. A., Bilous, R. W., Dashora, U., Heller, S. R., Hepburn, D. A., Shutler, S. D., Stephens, J. W., & Home, P. D. (2006). Improved glycaemic control with insulin glargine plus insulin lispro: a multicentre, randomized, cross-over trial in people with Type 1 diabetes. Diabetic Medicine : a Journal of the British Diabetic Association, 23(3), 285-92.
Ashwell SG, et al. Improved Glycaemic Control With Insulin Glargine Plus Insulin Lispro: a Multicentre, Randomized, Cross-over Trial in People With Type 1 Diabetes. Diabet Med. 2006;23(3):285-92. PubMed PMID: 16492212.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Improved glycaemic control with insulin glargine plus insulin lispro: a multicentre, randomized, cross-over trial in people with Type 1 diabetes. AU - Ashwell,S G, AU - Amiel,S A, AU - Bilous,R W, AU - Dashora,U, AU - Heller,S R, AU - Hepburn,D A, AU - Shutler,S D, AU - Stephens,J W, AU - Home,P D, PY - 2006/2/24/pubmed PY - 2006/8/15/medline PY - 2006/2/24/entrez SP - 285 EP - 92 JF - Diabetic medicine : a journal of the British Diabetic Association JO - Diabet. Med. VL - 23 IS - 3 N2 - AIMS: To compare blood glucose control using insulin glargine + insulin lispro with that on NPH insulin + unmodified human insulin in adults with Type 1 diabetes managed with a multiple injection regimen. METHODS: In this 32-week, five-centre, two-way cross-over study, people with Type 1 diabetes (n = 56, baseline HbA1c 8.0 +/- 0.8%) were randomized to evening insulin glargine + mealtime insulin lispro or to NPH insulin (once- or twice-daily) + mealtime unmodified human insulin. Each 16-week period concluded with a 24-h inpatient plasma glucose profile. RESULTS: HbA1c was lower with glargine + lispro than with NPH + human insulin [7.5 vs. 8.0%, difference -0.5 (95% CI -0.7, -0.3) %, P < 0.001]. This was confirmed by an 8% lower 24-h plasma glucose area under the curve (AUC) (187 vs. 203 mmol l(-1) h(-1), P = 0.037), a 24% reduction in plasma glucose AUC > 7.0 mmol/l1 (47 vs. 62 mmol l(-1) h(-1), P = 0.017) and a 15% lower post-prandial plasma glucose AUC (75 vs. 88 mmol l(-1) h(-1), P = 0.002). There was no reduction in night-time plasma glucose AUC or increase in plasma glucose area < 3.5 mmol/l. Monthly rate of nocturnal hypoglycaemia was reduced by 44% with glargine + lispro (0.66 vs. 1.18 episodes/month, P < 0.001). CONCLUSIONS: Compared with NPH insulin + unmodified human insulin, the combination of insulin glargine with a rapid-acting insulin analogue as multiple-injection therapy for Type 1 diabetes improves overall glycaemic control as assessed by HbA1c and 24-h plasma glucose monitoring to a clinically significant degree, together with a reduction in nocturnal hypoglycaemia. SN - 0742-3071 UR - https://www.unboundmedicine.com/medline/citation/16492212/Improved_glycaemic_control_with_insulin_glargine_plus_insulin_lispro:_a_multicentre_randomized_cross_over_trial_in_people_with_Type_1_diabetes_ L2 - https://doi.org/10.1111/j.1464-5491.2005.01781.x DB - PRIME DP - Unbound Medicine ER -