Comparison of Biphasic Insulin Aspart 30 and Biphasic Human Insulin 30 after 48 Weeks of Treatment in Type 2 Diabetes: Phase III Clinical Trial
|
Accession number;03A0624379
|
| Title;Comparison of Biphasic Insulin Aspart 30 and Biphasic Human Insulin 30 after 48 Weeks of Treatment in Type 2 Diabetes: Phase III Clinical Trial |
| Author;
IWAMOTO YASUHIKO
(Diabetes Center, Tokyo Women's Medical Univ., JPN)
AKANUMA YASUO
(Asahi Life Found., Inst. for Diabetes Care and Res.)
|
Journal Title;Journal of Clinical Therapeutics & Medicines
|
Journal Code:Y0906A
|
ISSN:0910-8211
|
|
VOL.19;NO.8;PAGE.891-904(2003)
|
| Figure&Table&Reference;FIG.2, TBL.7, REF.13 |
| Pub. Country;Japan |
| Language;Japanese |
| Abstract;The aim of this trial was to compare the efficacy and safety of biphasic insulin aspart 30 (BIAsp30) with those of biphasic human insulin 30 (30R) in Type 2 diabetes. In this multicentre, open-labeled, randomised, parallel group trial, 428 subjects were treated with either BIAsp3O twice daily immediately before breakfast and dinner (n= 321) or 30R twice daily 30 minutes before breakfast and dinner (n= 107) for 48 weeks. As for the primary endpoint of efficacy, HbA1C after 24 weeks of treatment, the least-squares means adjusted for baseline values were 7.31 .+-. 0.04% and 7.20 .+-. 0.06% (mean .+-. SE) for BIAsp3O group and 30R group, respectively. The mean treatment difference was 0.10% (95% C. I.: -0.04; 0.25), and the upper limit of C. I. was less than the upper equivalence margin (0.6%) defined as the non-inferiority criterion. A similar result was observed with analysis of HbA 1Cafter 48 weeks of treatment. Blood glucose (BG) level at 90 minutes after breakfast in the BIAsp3O group was statistically significantly lower than that in the 30R group after 24 weeks of treatment when adjusted for baseline value, while the BG level before breakfast was statistically significantly higher. However, this BG level before breakfast was lower than the baseline value. The total daily insulin dose increased slightly in both treatment groups throughout 48 weeks of treatment, 4.5 U in the BIAsp3O group and 2.8 IU in the 30R group respectively. However, the increase in the insulin doses from 24 to 48 weeks was similar in both treatment groups.The overall safety profile of BIAsp3O was comparable to that of 30R measured by adverse events, laboratory tests and other parameters. The proportion of subjects having at least one hypoglycaemic episode was similar in both treatment groups, 56.1% in the BIAsp3O group and 57.0% in the 30R group. Major hypoglycaemic episodes (requiring third-party assistance) were infrequent in both treatment groups.... (author abst.) |
|
|
|
Related Articles;
|
|
