MATERIALS AND METHODS: The EQ- 5D was cross-culturally adapted and translated using an iterative process following standard guidelines. Consenting adult Malay- and Tamil-speaking subjects at a primary care facility in Singapore were interviewed using a questionnaire (including the EQ-5D, a single item assessing global health, the SF-8 and sociodemographic questions) in their respective language versions. Known-groups and convergent construct validity of the EQ-5D was investigated by testing 30 a priori hypotheses per language at attribute and overall levels.
RESULTS: Complete data were obtained for 94 Malay and 78 Indian patients (median age, 54 years and 51 years, respectively). At the attribute level, all 16 hypotheses were fulfilled with several reaching statistical significance (Malay: 4; Tamil: 5). At the overall level, 42 of 44 hypotheses related to the EQ-5D/ EQ-VAS were fulfilled (Malay: 22; Tamil: 20), with 21 reaching statistical significance (Malay: 9; Tamil: 12).
CONCLUSION: In this study among primary care patients, the Singapore Malay and Tamil EQ-5D demonstrated satisfactory known-groups and convergent validity.
MATERIALS AND METHODS: In this open label, single-arm, observational, post marketing study, patients received biphasic isophane insulin injection as per the Prescribing Information; and were assessed for safety (adverse events including hypoglycaemia), effectiveness (glycosylated haemoglobin [HbA1c]; fasting blood sugar, [FBS]; and patient's condition by patient and physician) over a period of 24 weeks.
RESULTS: Adult male and female diabetes patients (N=119; type 2 DM, n=117) with a mean (SD) diabetes duration of 13 years were included. No new safety signals have been identified. Significant reduction in HbA1c was observed at weeks 12 and 24 (mean [SD] - baseline: 9.6% [1.9]; Week 12: 9.0% [1.7] and at Week 24: 9.1% [1.7]; p < 0.001). There were 10 serious and 9 non-serious adverse events reported in the study. Expected mild events included hypoglycaemia and injection site pruritus. However, the majority of the adverse events were non-study drug related events. No deaths were reported during the study.
DISCUSSION: Biphasic isophane insulin injection was well tolerated with no new safety concerns. It was found effective in post- marketing studies conducted in routine clinical settings when administered in DM patients in this study.