TY - JOUR
T1 - 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
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 - Iperen Av, A. van
AU - Snoek, F. J.
AU - Heine, R. J.
AU - van Iperen, A.
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 HbA(1c) 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 HbA(1c) level <or =6.5%. RESULTS: Mean HbA(1c) 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 HbA(1c) 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 HbA(1c) 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 HbA(1c) level <or =6.5%. RESULTS: Mean HbA(1c) 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 HbA(1c) 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 - https://doi.org/10.1002/dmrr.356
DO - https://doi.org/10.1002/dmrr.356
M3 - Article
C2 - 12673783
SN - 1520-7552
VL - 19
SP - 148
EP - 152
JO - Diabetes/metabolism research and reviews
JF - Diabetes/metabolism research and reviews
IS - 2
ER -