Evaluation of the effectiveness and tolerability of gliclazide modified release 60 mg in patients with type 2 diabetes observing fasting during Ramadan in Pakistan: An analysis from the global DIA-RAMADAN study.

AIM: To assess safety and effectiveness of gliclazide MR 60 mg in people with controlled or suboptimal controlled T2DM treated with breakable gliclazide MR 60 mg formulation. METHOD: This study data has been extracted from an international, observational study conducted in nine Asian and Middle Eastern countries. Total 220 patients with T2DM were recruited from Pakistan. The primary endpoint was the proportion of patients reporting at least 1 symptomatic HE, whereas secondary endpoints were changes in glycosylated haemoglobin (HbA1c) %, fasting plasma glucose (FPG) mg/dL, and body weight (kg) and proportion of patients reporting any HE (confirmed or severe), between inclusion visit (V0) and end of the study visit (V1). RESULTS: During Ramadan, 3.6% (n = 8/220) patients had experienced at least one symptomatic HEs. A significant (p-value < 0.001) reduction was observed in HbA1c: (mean [SD]) (-0.4 [0.9] %), and body weight (-0.7 [4.8] kg). Thirteen adverse events (AEs) unrelated to gliclazide MR were reported during the study pre-Ramadan and post-Ramadan periods. CONCLUSION: This study shows safety and effectiveness profile of gliclazide MR 60 mg by emphasizing on the low risk of HEs, effective glycaemic control and body weight reduction in T2DM patients, who are inclined to fasting during Ramadan.

Switch from biphasic human insulin 30 to biphasic insulin aspart 30 in Pakistani subjects.

OBJECTIVE: To determine the safety and effectiveness of biphasic insulin aspart 30 (BIAsp 30) in type 2 diabetes subjects switched from biphasic human insulin 30 (BHI 30) in the Pakistani subgroup of the multinational, prospective, non-interventional A1chieve study. METHODS: Subjects who switched therapy from BHI 30 to BIAsp 30 were included in this analysis. Serious adverse drug reactions (SADRs, including major hypoglycaemia) and effectiveness parameters (glycated haemoglobin [HbA1c], fasting plasma glucose [FPG], postprandial plasma glucose [PPPG], systolic blood pressure [SBP]) and body weight were evaluated at the end of 24 weeks. RESULTS: A total of 152 subjects (79 males, 73 females; mean age, 53.4 +/- 10.3 years; BMI, 28.4 +/- 5.8 kg/m2) with an average diabetes duration of 11.2 +/- 4.8 years switched therapy from BHI 30 to BIAsp 30. The mean pre-study BHI 30 dose was 0.66 +/- 0.25 IU/kg and the mean starting BIAsp 30 dose was 0.65 +/- 0.23 U/kg, titrated up to 0.77 +/- 0.22 U/kg after 24 weeks. No SADRs were reported. From baseline to Week 24, overall hypoglycaemia did not change and no major hypoglycaemia was reported at Week 24. HbA1c levels decreased significantly from 9.1 +/- 1.1% at baseline to 7.4 +/- 0.7% (57 +/- 8 mmol/mol) at Week 24 (p < 0.001). Significant improvements in FPG, post-breakfast PPPG and SBP were reported (p < 0.001). CONCLUSION: Switching from BHI 30 to BIAsp 30 was well tolerated and improved glucose control without an increased incidence of hypoglycaemia in this Pakistani cohort.

Safety and effectiveness of biphasic insulin aspart 30 (Biasp 30) in people with type 2 diabetes mellitus in the pakistani population: results from the A1chieve study.

OBJECTIVE: To explore the safety and effectiveness of treatment with the insulin analogue, biphasic insulin aspart 30 (BIAsp 30), in people with type 2 diabetes mellitus (T2DM) in a subgroup of a Pakistani population from the A1chieve study. METHODS: A1chieve was a 24-week, international, prospective, multicentre, open label, observational, non-interventional study designed to evaluate the safety and clinical effectiveness of 66,726 people with T2DM who were initiated with basal insulin detemir, fast actinginsulin aspart, and BIAsp 30 (30% soluble insulin aspart, 70% protamine-crystallized insulin aspart). The study was conducted in 28 countries across Asia, Africa, Latin America, and Europe. Here, we report data from a subgroup of 762 people with T2DM from the Pakistani cohort (insulin naïve and insulin users) who were treated withpremix insulin (BIAsp 30) +/- oral antidiabetic drugs (OADs). RESULTS: The decrease in HbAlc at week 24 was statistically significant in the entire cohort, the insulin naïve, and insulin users (1.7 +/- 1.1%, 1.8 +/- 1.3% and 1.7 +/- 0.9%, respectively, p<0.001 for all).There was a statistically significant decrease in the mean fasting plasma glucose (FPG) and postprandial plasma glucose (PPG) from baseline toweek 24 in the entire cohort, in the insulin naïve and in the insulin users with BIAsp 30 treatment (p<0.001 for all).No major hypoglycaemic events were reported during the entire study period. There was a statistically significant decrease in the systolic blood pressure (SBP) in all groups (p<0.001). The improvement in the quality of life score (QoL)was statistically significant in all groups (p<0.001 for all). CONCLUSION: BIAsp 30 treatment appeared to be well tolerated and effective as indicated byimproved glycaemiccontrol and QoL in people with T2DM in the Pakistani population after 24 weeks.