Safety and effectiveness of insulin detemir in type 2 diabetes: Results from the ASEAN cohort of the A1chieve study
Diabetes Research and Clinical Practice, pages S10 - S16
Published online août-2013
To determine the safety and effectiveness of insulin detemir (IDet) in type 2 diabetes patients from the ASEAN cohort of the A1chieve study.
Patients from Indonesia, Malaysia, Philippines and Singapore prescribed IDet at the discretion of their physicians were included. The primary outcome was the incidence of serious adverse drug reactions including major hypoglycaemia over 24 weeks. Secondary endpoints included changes in the frequency of hypoglycaemia, serious adverse events and effectiveness assessments.
This sub-analysis included 1540 patients (insulin-naive, 1239; insulin-experienced, 301) with mean age ± SD 56.4±10.9 years, BMI 25.4±4.6kg/m2 and diabetes duration 6.9±5.3 years. Insulin-naive patients received a baseline IDet dose of 0.24±0.11U/kg titrated up to 0.37±0.21 U/kg by Week 24. The pre-study insulin dose in insulin-experienced patients was 0.41±0.25 U/kg and baseline IDet dose was 0.31±0.24U/kg titrated up to 0.40±0.20 U/kg by Week 24. Overall hypoglycaemia decreased from 1.73 to 0.46 events/patient-year from baseline to Week 24 (change in proportion of patients affected, p < 0.0001). At Week 24, 1 major hypoglycaemic event was reported in 1 insulin-experienced patient. IDet significantly improved glucose control (p < 0.001) at Week 24. The lipid profile and systolic blood pressure improved (p < 0.001) and body weight did not change significantly. Quality of life was positively impacted (p < 0.001).
IDet was well-tolerated and improved glycaemic control without increasing the risk of hypoglycaemia or weight gain.
Keywords: ASEAN, Type 2 diabetes, Insulin detemir.
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a University of Indonesia, Cipto Mangunkusomo Hospital, Jakarta, Indonesia University of Indonesia, Cipto Mangunkusomo Hospital, Jakarta, Indonesia
b Universiti Sains Malaysia, Kelantan, Malaysia Universiti Sains Malaysia, Kelantan, Malaysia
c Novo Nordisk Pharma Malaysia Sdn Bhd, Kuala Lumpur, Malaysia Novo Nordisk Pharma Malaysia Sdn Bhd, Kuala Lumpur, Malaysia
d Cardinal Santos Medical Center, San Juan, Metro Manila, Philippines Cardinal Santos Medical Center, San Juan, Metro Manila, Philippines
e Department of Medicine, Yong Loo Ling School of Medicine, National University of Singapore, Singapore Department of Medicine, Yong Loo Ling School of Medicine, National University of Singapore, Singapore
Corresponding author at: SpPD-KEMO, Division of Endorinology, Department of Internal Medicine, Faculty of Medicine, University of Indonesia, Cipto Mangunkusomo Hospital, Jakarta, Indonesia. Tel.: +62 21 390 7703; fax: +62 21 392 8659
© 2013 Published by Elsevier B.V.