TY - JOUR
T1 - Clinical safety and effectiveness of biphasic insulin aspart 30 in type 2 diabetes patients switched from biphasic human insulin 30
T2 - Results from the Indonesian cohort of the A1chieve study
AU - Soewondo, Pradana
AU - Lindarto, Dharma
AU - Wibisono, Sony
AU - Renaldi, Olly
AU - Dalem-Pemayun, Tjokorda Gde
N1 - Funding Information:
Dr. Pradana Soewondo has authored an article sponsored by Novo Nordisk and sanofi aventis, and has served as a consultant (Advisory Board) for Novo Nordisk, sanofi aventis, and Novartis. Dr. Pradana Soewondo has also received research grants from World Diabetes Foundation and grants for lectures from Novo Nordisk, sanofi aventis, Novartis and MSD. Dr. Tjokorda Gde Dalem-Pemayun has served as a consultant (Advisory board) for MSD, AstraZeneca and sanofi aventis and has received honorarium for lectures from Novo Nordisk, sanofi aventis, Merck, MSD, AstraZeneca, Eli Lilly and Kalbe Farma. No other author has any conflict of interest to report. This study was sponsored by Novo Nordisk A/S, Denmark. The sponsor took part in the development of the protocol, the process of data collection and analysis, funding of medical writing services, and in reviewing the manuscript, but not in participant selection, choice of therapies (study or otherwise), provision of therapies including insulin or continuing clinical management of the participants.
Funding Information:
The authors would like to thank the entire study group, their staff, clinical trial personnel and investigators involved in the A1chieve study. Special thanks to all the patients and investigators for their participation in this study. The authors would like to thank Chunduo Shen of Novo Nordisk for providing statistical analysis. The authors would also like to thank Ruchita Kapoor from Cognizant Technology Solutions for writing assistance, funded by Novo Nordisk.
PY - 2013
Y1 - 2013
N2 - Aim: To evaluate the safety and effectiveness of biphasic insulin aspart 30 (BIAsp 30) in Indonesian type 2 diabetes patients switched from biphasic human insulin 30 (BHI 30) as a sub-analysis of the A1chieve study. Methods: Clinical safety and effectiveness over 24 weeks was evaluated in Indonesian patients who switched from BHI 30 to BIAsp 30 at the discretion of their physician. Results: A total of 244 patients with mean age ± SD 55.6±9.5 years, BMI 24.6±3.8kg/m2, and mean diabetes duration 7.8±5.7 years were included. The mean pre-study BHI 30 dose was 0.56±0.25 IU/kg and the baseline BIAsp 30 dose was 0.60±0.26U/kg titrated up to 0.65±0.25 U/kg by Week 24. No serious adverse drug reactions were reported throughout the study. Overall hypoglycaemia decreased from 2.18 to 0.06 events/patient-year with a significant decrease in the proportion of patients affected (p < 0.0001). No nocturnal or major hypoglycaemia was reported at Week 24. HbA1c improved from 8.8±1.2% at baseline to 7.3±0.8% at Week 24. A total of 45 patients achieved HbA1c <7.0% as compared to 5 patients with HbA1c <7.0% at baseline. FPG and PPPG improved significantly after 24 weeks (p < 0.001). Quality of life was positively impacted (change in visual analogue scores, 3.0±11.6 points, p < 0.001). Conclusion: Switching from BHI 30 to BIAsp 30 in this Indonesian cohort was well-tolerated and improved glycaemic control with a decreased risk of hypoglycaemia.
AB - Aim: To evaluate the safety and effectiveness of biphasic insulin aspart 30 (BIAsp 30) in Indonesian type 2 diabetes patients switched from biphasic human insulin 30 (BHI 30) as a sub-analysis of the A1chieve study. Methods: Clinical safety and effectiveness over 24 weeks was evaluated in Indonesian patients who switched from BHI 30 to BIAsp 30 at the discretion of their physician. Results: A total of 244 patients with mean age ± SD 55.6±9.5 years, BMI 24.6±3.8kg/m2, and mean diabetes duration 7.8±5.7 years were included. The mean pre-study BHI 30 dose was 0.56±0.25 IU/kg and the baseline BIAsp 30 dose was 0.60±0.26U/kg titrated up to 0.65±0.25 U/kg by Week 24. No serious adverse drug reactions were reported throughout the study. Overall hypoglycaemia decreased from 2.18 to 0.06 events/patient-year with a significant decrease in the proportion of patients affected (p < 0.0001). No nocturnal or major hypoglycaemia was reported at Week 24. HbA1c improved from 8.8±1.2% at baseline to 7.3±0.8% at Week 24. A total of 45 patients achieved HbA1c <7.0% as compared to 5 patients with HbA1c <7.0% at baseline. FPG and PPPG improved significantly after 24 weeks (p < 0.001). Quality of life was positively impacted (change in visual analogue scores, 3.0±11.6 points, p < 0.001). Conclusion: Switching from BHI 30 to BIAsp 30 in this Indonesian cohort was well-tolerated and improved glycaemic control with a decreased risk of hypoglycaemia.
KW - Biphasic human insulin 30
KW - Biphasic insulin aspart 30
KW - Indonesia
KW - Switch
UR - http://www.scopus.com/inward/record.url?scp=84877144798&partnerID=8YFLogxK
U2 - 10.1016/S0168-8227(13)70009-3
DO - 10.1016/S0168-8227(13)70009-3
M3 - Article
C2 - 23647718
AN - SCOPUS:84877144798
SN - 0168-8227
VL - 100
SP - S41-S46
JO - Diabetes Research and Clinical Practice
JF - Diabetes Research and Clinical Practice
IS - SUPPL.1
ER -
