Skip to main content

Lund University Publications

LUND UNIVERSITY LIBRARIES

Biphasic insulin aspart given thrice daily is as efficacious as a basal-bolus insulin regimen with four daily injections: A randomised open-label parallel group four months comparison in patients with type 2 diabetes

Ligthelm, R. J. ; Mouritzenz, U. ; Lynggaard, H. ; Landin-Olsson, Mona LU ; Fox, C. ; Le Devehat, C. ; Rorneros, E. and Liebl, A. (2006) In Experimental and Clinical Endocrinology & Diabetes 114(9). p.511-519
Abstract
Aims: To show that a thrice daily meal-time biphasic insulin aspart (BIAsp) treatment regimen is as efficacious as a 4 times daily basal-bolus regimen with human isophane insulin (NPH) and insulin aspart (IAsp). Methods: A multinational, randomised, open-label parallel-group trial in 394 patients with type 2 diabetes on a once or twice daily insulin regimen. Patients were randomised 1:1 to BIAsp or IAsp+NPH for 16 weeks. The BIAsp group was treated according to individual needs using BMI as a surrogate index of insulin resistance. Subjects administered BIAsp 70 (BMI < 30 kg/m(2)) or BIAsp 50 (BMI > 30 kg/m(2)) with breakfast and lunch and BIAsp 30 with dinner. The IAsp + NPH group injected IAsp at meals and NPH at bedtime as basal... (More)
Aims: To show that a thrice daily meal-time biphasic insulin aspart (BIAsp) treatment regimen is as efficacious as a 4 times daily basal-bolus regimen with human isophane insulin (NPH) and insulin aspart (IAsp). Methods: A multinational, randomised, open-label parallel-group trial in 394 patients with type 2 diabetes on a once or twice daily insulin regimen. Patients were randomised 1:1 to BIAsp or IAsp+NPH for 16 weeks. The BIAsp group was treated according to individual needs using BMI as a surrogate index of insulin resistance. Subjects administered BIAsp 70 (BMI < 30 kg/m(2)) or BIAsp 50 (BMI > 30 kg/m(2)) with breakfast and lunch and BIAsp 30 with dinner. The IAsp + NPH group injected IAsp at meals and NPH at bedtime as basal insulin. HbA(lc) levels after 16 weeks were compared between treatments using a predefined non-inferiority criterion of 0.4%. The incidence of BIAsp was non-inferior to that obtained by the IAsp+NPH (intention to treat [ITT]) population: diff, HbA(lc)-0.05%; 95% CI (-0.24; 0.14); per protocol (PP) population: diff, HbA(lc)-0.03%; 95% CI (-0.23; 0.16). Similar improvements in glycaemic control in both groups were confirmed by self-measured 8-point plasma glucose (PG) profiles, average and fasting PG concentrations, and average prandial PG increments. The incidence of adverse events and hypoglycaemic episodes was similar in the two treatment groups. Conclusions: A thrice daily meal-time BIAsp regimen is a suitable alternative to an intensified insulin regimen in people with inadequately controlled type 2 diabetes mellitus, and requires fewer daily injections than a basal-bolus therapy without compromising efficacy and safety. (Less)
Please use this url to cite or link to this publication:
author
; ; ; ; ; ; and
organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
glycaemic control MS, biphasic insulin, aspart, insulin aspart, premixed insulin analogues, thrice daily, basal-bolus regimen, insulin regimen, insulin, NovoMix 50, NovoMix 70, NovoMix30, type 2 diabetes
in
Experimental and Clinical Endocrinology & Diabetes
volume
114
issue
9
pages
511 - 519
publisher
Georg Thieme Verlag KG
external identifiers
  • wos:000242232800006
  • scopus:33845309408
ISSN
1439-3646
DOI
10.1055/s-2006-924424
language
English
LU publication?
yes
id
475edcf4-c032-4966-8798-9976b590aa51 (old id 376587)
date added to LUP
2016-04-01 12:14:41
date last changed
2020-03-11 02:50:37
@article{475edcf4-c032-4966-8798-9976b590aa51,
  abstract     = {Aims: To show that a thrice daily meal-time biphasic insulin aspart (BIAsp) treatment regimen is as efficacious as a 4 times daily basal-bolus regimen with human isophane insulin (NPH) and insulin aspart (IAsp). Methods: A multinational, randomised, open-label parallel-group trial in 394 patients with type 2 diabetes on a once or twice daily insulin regimen. Patients were randomised 1:1 to BIAsp or IAsp+NPH for 16 weeks. The BIAsp group was treated according to individual needs using BMI as a surrogate index of insulin resistance. Subjects administered BIAsp 70 (BMI &lt; 30 kg/m(2)) or BIAsp 50 (BMI &gt; 30 kg/m(2)) with breakfast and lunch and BIAsp 30 with dinner. The IAsp + NPH group injected IAsp at meals and NPH at bedtime as basal insulin. HbA(lc) levels after 16 weeks were compared between treatments using a predefined non-inferiority criterion of 0.4%. The incidence of BIAsp was non-inferior to that obtained by the IAsp+NPH (intention to treat [ITT]) population: diff, HbA(lc)-0.05%; 95% CI (-0.24; 0.14); per protocol (PP) population: diff, HbA(lc)-0.03%; 95% CI (-0.23; 0.16). Similar improvements in glycaemic control in both groups were confirmed by self-measured 8-point plasma glucose (PG) profiles, average and fasting PG concentrations, and average prandial PG increments. The incidence of adverse events and hypoglycaemic episodes was similar in the two treatment groups. Conclusions: A thrice daily meal-time BIAsp regimen is a suitable alternative to an intensified insulin regimen in people with inadequately controlled type 2 diabetes mellitus, and requires fewer daily injections than a basal-bolus therapy without compromising efficacy and safety.},
  author       = {Ligthelm, R. J. and Mouritzenz, U. and Lynggaard, H. and Landin-Olsson, Mona and Fox, C. and Le Devehat, C. and Rorneros, E. and Liebl, A.},
  issn         = {1439-3646},
  language     = {eng},
  number       = {9},
  pages        = {511--519},
  publisher    = {Georg Thieme Verlag KG},
  series       = {Experimental and Clinical Endocrinology & Diabetes},
  title        = {Biphasic insulin aspart given thrice daily is as efficacious as a basal-bolus insulin regimen with four daily injections: A randomised open-label parallel group four months comparison in patients with type 2 diabetes},
  url          = {http://dx.doi.org/10.1055/s-2006-924424},
  doi          = {10.1055/s-2006-924424},
  volume       = {114},
  year         = {2006},
}