Combined bedtime insulin - Daytime sulphonylurea regimen compared with two different daily insulin regimens in type 2 diabetes: Effects on HbA1c and hypoglycaemia rate - A randomised trial

M. H A Stehouwer, J. H. DeVries, J. A E Lumeij, H. J. Adèr, A. M S Engbers, A. van Iperen, F. J. Snoek, R. J. Heine

Research output: Contribution to journalArticleAcademicpeer-review

Abstract

Background. Several efficacy studies of insulin-therapy regimens in patients with type 2 diabetes mellitus have shown varying results. Moreover, most studies did not address hypoglycaemia frequency and severity. Methods. In this multicentre study, we compared the glycaemic efficacy and incidence rate of hypoglycaemic episodes between 3 treatment regimens in obese type 2 diabetic patients with secondary failure to sulphonylurea and metformin. During the run-in phase, patients were treated with glimepiride and metformin. After 3 months, 261 patients with HbA1c values >6.5% were randomised to (A) glimepiride + Neutral Protein Hagedorn (NPH) insulin at bedtime, (B) NPH insulin twice daily and (C) 30/70 mixture of short-acting and NPH insulin twice daily. The therapeutic aim was an HbA1c level ≤6.5%. Results. Mean HbA1c achieved at 9 months was significantly higher in group A: 8.9% versus 8.3% and 8.4% in groups B and C, respectively (P < 0.001). There was no difference in the mild hypoglycaemic event rate, 0.36 versus 0.48 versus 0.53 events per patient month, in groups A, B and C, respectively. Severe hypoglycaemic events, requiring help from others, did not occur throughout the study. The mean weight gain and insulin dose were comparable in all three groups. Conclusions. The glimepiride + NPH insulin treatment resulted in a higher HbA1c level, as compared to the other regimens. In the clinical setting of this multicentre study, good glycaemic control was only achieved in a minority of the patients, irrespective of the applied regimen.

Original languageEnglish
Pages (from-to)148-152
Number of pages5
JournalDiabetes/Metabolism Research and Reviews
Volume19
Issue number2
DOIs
Publication statusPublished - 1 Mar 2003

Cite this

@article{5ca751054b164072810690236fe1a7f1,
title = "Combined bedtime insulin - Daytime sulphonylurea regimen compared with two different daily insulin regimens in type 2 diabetes: Effects on HbA1c and hypoglycaemia rate - A randomised trial",
abstract = "Background. Several efficacy studies of insulin-therapy regimens in patients with type 2 diabetes mellitus have shown varying results. Moreover, most studies did not address hypoglycaemia frequency and severity. Methods. In this multicentre study, we compared the glycaemic efficacy and incidence rate of hypoglycaemic episodes between 3 treatment regimens in obese type 2 diabetic patients with secondary failure to sulphonylurea and metformin. During the run-in phase, patients were treated with glimepiride and metformin. After 3 months, 261 patients with HbA1c values >6.5{\%} were randomised to (A) glimepiride + Neutral Protein Hagedorn (NPH) insulin at bedtime, (B) NPH insulin twice daily and (C) 30/70 mixture of short-acting and NPH insulin twice daily. The therapeutic aim was an HbA1c level ≤6.5{\%}. Results. Mean HbA1c achieved at 9 months was significantly higher in group A: 8.9{\%} versus 8.3{\%} and 8.4{\%} in groups B and C, respectively (P < 0.001). There was no difference in the mild hypoglycaemic event rate, 0.36 versus 0.48 versus 0.53 events per patient month, in groups A, B and C, respectively. Severe hypoglycaemic events, requiring help from others, did not occur throughout the study. The mean weight gain and insulin dose were comparable in all three groups. Conclusions. The glimepiride + NPH insulin treatment resulted in a higher HbA1c level, as compared to the other regimens. In the clinical setting of this multicentre study, good glycaemic control was only achieved in a minority of the patients, irrespective of the applied regimen.",
keywords = "Glimepiride, Hypoglycaemic events, Insulin regimens, Oral hypoglycaemic agents, Secondary failure, Type 2 diabetes mellitus",
author = "Stehouwer, {M. H A} and DeVries, {J. H.} and Lumeij, {J. A E} and Ad{\`e}r, {H. J.} and Engbers, {A. M S} and {van Iperen}, A. and Snoek, {F. J.} and Heine, {R. J.}",
year = "2003",
month = "3",
day = "1",
doi = "10.1002/dmrr.356",
language = "English",
volume = "19",
pages = "148--152",
journal = "Diabetes/Metabolism Research and Reviews",
issn = "1520-7552",
number = "2",

}

Combined bedtime insulin - Daytime sulphonylurea regimen compared with two different daily insulin regimens in type 2 diabetes : Effects on HbA1c and hypoglycaemia rate - A randomised trial. / Stehouwer, M. H A; DeVries, J. H.; Lumeij, J. A E; Adèr, H. J.; Engbers, A. M S; van Iperen, A.; Snoek, F. J.; Heine, R. J.

In: Diabetes/Metabolism Research and Reviews, Vol. 19, No. 2, 01.03.2003, p. 148-152.

Research output: Contribution to journalArticleAcademicpeer-review

TY - JOUR

T1 - Combined bedtime insulin - Daytime sulphonylurea regimen compared with two different daily insulin regimens in type 2 diabetes

T2 - Effects on HbA1c and hypoglycaemia rate - A randomised trial

AU - Stehouwer, M. H A

AU - DeVries, J. H.

AU - Lumeij, J. A E

AU - Adèr, H. J.

AU - Engbers, A. M S

AU - van Iperen, A.

AU - Snoek, F. J.

AU - Heine, R. J.

PY - 2003/3/1

Y1 - 2003/3/1

N2 - Background. Several efficacy studies of insulin-therapy regimens in patients with type 2 diabetes mellitus have shown varying results. Moreover, most studies did not address hypoglycaemia frequency and severity. Methods. In this multicentre study, we compared the glycaemic efficacy and incidence rate of hypoglycaemic episodes between 3 treatment regimens in obese type 2 diabetic patients with secondary failure to sulphonylurea and metformin. During the run-in phase, patients were treated with glimepiride and metformin. After 3 months, 261 patients with HbA1c values >6.5% were randomised to (A) glimepiride + Neutral Protein Hagedorn (NPH) insulin at bedtime, (B) NPH insulin twice daily and (C) 30/70 mixture of short-acting and NPH insulin twice daily. The therapeutic aim was an HbA1c level ≤6.5%. Results. Mean HbA1c achieved at 9 months was significantly higher in group A: 8.9% versus 8.3% and 8.4% in groups B and C, respectively (P < 0.001). There was no difference in the mild hypoglycaemic event rate, 0.36 versus 0.48 versus 0.53 events per patient month, in groups A, B and C, respectively. Severe hypoglycaemic events, requiring help from others, did not occur throughout the study. The mean weight gain and insulin dose were comparable in all three groups. Conclusions. The glimepiride + NPH insulin treatment resulted in a higher HbA1c level, as compared to the other regimens. In the clinical setting of this multicentre study, good glycaemic control was only achieved in a minority of the patients, irrespective of the applied regimen.

AB - Background. Several efficacy studies of insulin-therapy regimens in patients with type 2 diabetes mellitus have shown varying results. Moreover, most studies did not address hypoglycaemia frequency and severity. Methods. In this multicentre study, we compared the glycaemic efficacy and incidence rate of hypoglycaemic episodes between 3 treatment regimens in obese type 2 diabetic patients with secondary failure to sulphonylurea and metformin. During the run-in phase, patients were treated with glimepiride and metformin. After 3 months, 261 patients with HbA1c values >6.5% were randomised to (A) glimepiride + Neutral Protein Hagedorn (NPH) insulin at bedtime, (B) NPH insulin twice daily and (C) 30/70 mixture of short-acting and NPH insulin twice daily. The therapeutic aim was an HbA1c level ≤6.5%. Results. Mean HbA1c achieved at 9 months was significantly higher in group A: 8.9% versus 8.3% and 8.4% in groups B and C, respectively (P < 0.001). There was no difference in the mild hypoglycaemic event rate, 0.36 versus 0.48 versus 0.53 events per patient month, in groups A, B and C, respectively. Severe hypoglycaemic events, requiring help from others, did not occur throughout the study. The mean weight gain and insulin dose were comparable in all three groups. Conclusions. The glimepiride + NPH insulin treatment resulted in a higher HbA1c level, as compared to the other regimens. In the clinical setting of this multicentre study, good glycaemic control was only achieved in a minority of the patients, irrespective of the applied regimen.

KW - Glimepiride

KW - Hypoglycaemic events

KW - Insulin regimens

KW - Oral hypoglycaemic agents

KW - Secondary failure

KW - Type 2 diabetes mellitus

UR - http://www.scopus.com/inward/record.url?scp=0037357860&partnerID=8YFLogxK

U2 - 10.1002/dmrr.356

DO - 10.1002/dmrr.356

M3 - Article

VL - 19

SP - 148

EP - 152

JO - Diabetes/Metabolism Research and Reviews

JF - Diabetes/Metabolism Research and Reviews

SN - 1520-7552

IS - 2

ER -