Real-world evidence on the effectiveness and safety of gliclazide MR 60 mg in Bangladeshi patients with Type II diabetes during fasting: a sub-analysis from the global DIA-RAMADAN study.

Aim: Many Muslims with Type II diabetes (T2DM) fast during Ramadan, which can put them at increased risk of hypoglycemia. This sub-analysis of the global DIA-RAMADAN study assessed the effectiveness and safety of gliclazide modified release (MR) 60 mg in the Bangladeshi cohort. Materials & methods: DIA-RAMADAN was an international, prospective, observational study conducted in adult T2DM patients intending to fast and receiving gliclazide MR 60 mg once daily for ≥90 days before Ramadan. Dosing was switched from morning to evening at the start of Ramadan. The primary outcome was the proportion of patients with ≥1 symptomatic hypoglycemic event. Secondary outcomes included changes between inclusion (V0) and end of study visit (V1) in glycated hemoglobin (HbA1c), body weight and fasting plasma glucose (FPG). Results: Among the 98 Bangladeshi patients, 80 (81.6%) were at moderate/low-risk (category 3) for fasting and 18 (18.4%) were high-risk (category 2), as per International Diabetes Federation and Diabetes and Ramadan International Alliance (IDF-DAR) guidelines. Gliclazide MR was being prescribed as monotherapy to 59 (60.2%) patients and in combination with metformin to 39 (39.8%). There was no incidence of severe hypoglycemic events. Mean (±SD) HbA1c change from V0 was -0.1 ± 0.8% (p = 0.159). Mean (±SD) changes in FPG and body weight were -0.8 ± 39.7 mg/dl (p = 0.876) and -0.0 ± 1.5 kg (p = 0.810), respectively. Conclusion: In a real-world setting, this sub-analysis in Bangladeshi patients shows that patients with T2DM treated with gliclazide MR 60 mg can fast safely during Ramadan with a very low risk of hypoglycemia, while maintaining glycemic control and body weight.

Presence and association of sub clinical hypothyroidism in subjects with metabolic syndrome.

AIMS: To determine the prevalence of subclinical hypothyroidism (SCH) among subjects with metabolic syndrome and to find out the relationship of subclinical hypothyroidism with different components of metabolic syndrome. MATERIALS AND METHODS: The study was conducted in the Department of Endocrinology, Bangladesh Institute of Research and Rehabilitation in Diabetes, Endocrine and Metabolic Disorders (BIRDEM), Dhaka during the period of April 2008-March 2009. One hundred and seventy three subjects with metabolic syndrome (according to IDF criteria) aged 20-69 years were included in the study. After primary selection, FPG and lipid profile were done. Those who had FPG≥100mg/dl or dislipidemia were selected for routine investigations such as SGPT, S. creatinine, TC, DC, ESR, HB%, ECG, and Ultrasonography of whole abdomen to exclude liver disease, renal disease, acute illness and cardiac disease respectively. Patients having normal investigations were finally selected for serum level of FT4 and TSH. RESULTS: A total of 173 subjects (105 male, and 68 female,) with metabolic syndrome were studied. Among them 14.3% (n=15) of male and 19.1% (n=13) of female had SCH. SCH was found more in obese subjects (BMI≥25kg/m(2) vs. BMI<25kg/m(2)). There was no significant difference among different parameters of metabolic syndrome in subjects with or without SCH. Although SCH was more prevalent in those who had hypertrigyceridemia and hypertension, there was no association between presence of fatty liver and SCH. CONCLUSIONS: Among the study subjects 14.3% male and 19.1% female had SCH. SCH is more prevalent in 41-60 years age group. No significant association was found among different parameters of MetS with SCH, however, when they constitute metabolic syndrome; there was a significant association between MetS and SCH.