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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
Author(s) -
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.
Publication year - 2006
Publication title -
diabetic medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.474
H-Index - 145
eISSN - 1464-5491
pISSN - 0742-3071
DOI - 10.1111/j.1464-5491.2005.01781.x
Subject(s) - medicine , insulin glargine , insulin lispro , nph insulin , endocrinology , insulin , type 2 diabetes , diabetes mellitus , area under the curve , hypoglycemia
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 HbA 1c 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 HbA 1c 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/l 1 (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 HbA 1c and 24‐h plasma glucose monitoring to a clinically significant degree, together with a reduction in nocturnal hypoglycaemia.