RESUMEN
OBJECTIVES: The objective of this study was to assess the incidence of hypoglycemia in patients with type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM) in Bangladeshi cohort of the International Operations-Hypoglycemia Assessment Tool study. MATERIALS AND METHODS: Patients diagnosed with either T1DM or T2DM, aged ≥18 years, treated with insulin (any regimen) for >12 months, and completed self-assessment questionnaires (SAQs) to record demography, treatment information, and hypoglycemia during the 6-month retrospective and 4-week prospective periods (a total of 7 months) were enrolled in the study. RESULTS: A total of 1179 patients were enrolled and completed the SAQ1 (T1DM, n = 25; T2DM, n = 1154). Almost all patients (T1DM: 100.0% [95% confidence interval (CI): 86.3%, 100.0%] and T2DM: 97.0% [95% CI: 95.9%, 97.9%]) experienced at least 1 hypoglycemic event prospectively. The estimated rates of any and severe hypoglycemia were 26.6 (95% CI: 19.8, 35.0) and 14.1 (95% CI: 9.3, 20.4) events per patient-per year (PPY), respectively, for patients with T1DM and 18.3 (95% CI: 17.4, 19.2) and 12.1 (95% CI: 11.4, 12.9) events PPY, respectively, for patients with T2DM during the prospective period. At baseline, mean glycated hemoglobin (HbA1c) (±standard deviation) was 8.1 (±1.8%) for T1DM and 8.8 (±1.8%) for T2DM. Hypoglycemic rate was independent of HbA1c levels and types of insulin. CONCLUSIONS: This is the first patient dataset of self-reported hypoglycemia in Bangladesh; results confirm that hypoglycemia is underreported.
RESUMEN
AIM: To determine the safety and effectiveness of biphasic insulin aspart 30 (BIAsp 30) therapy in Bangladeshi type 2 diabetes (T2D) patients switched from biphasic human insulin (BHI) as a sub-analysis of the A1chieve study. METHODS: Bangladeshi patients switched from BHI to BIAsp 30 at the discretion of their physicians were included. The primary outcome was the incidence of serious adverse drug reactions (SADRs), including major hypoglycaemia. Secondary outcomes comprised changes from baseline to Week 24 in the number of hypoglycaemic events, glycated haemoglobin A1c (HbA1c), fasting plasma glucose (FPG), postprandial plasma glucose (PPPG), systolic blood pressure and body weight. Quality of life (QoL) was evaluated at baseline and Week 24 using the EQ-5D questionnaire. RESULTS: A total of 82 patients (mean age ± SD: 52.3 ± 12.2 years; body mass index: 25.6 ± 3.3 kg/m(2)) with a mean diabetes duration of 9.5 ± 5.5 years and mean duration on insulin of 2.5 ± 2.4 years were included. The mean BIAsp 30 dose was 0.49 ± 0.20 U/kg at baseline and 0.47 ± 0.17 U/kg at Week 24. No SADRs were reported. No events of hypoglycaemia (overall, major, minor or nocturnal) were reported at Week 24. Mean HbA1c, FPG and PPPG levels improved by -2.5 ± 1.3%, -65.0 ± 31.8 mg/dL and -119.3 ± 48.7 mg/dL, respectively, over 24 weeks. QoL also improved (mean change from baseline: +28.5 ± 12.9 points). CONCLUSION: Switching from BHI to BIAsp 30 therapy improved blood glucose control and was well-tolerated in this Bangladeshi subgroup.