OBJECTIVE: To evaluate the safety, effectiveness and health-related quality of life (HRQoL) parameters of A1chieve study participants in the Philippine cohort, who were treated with BIAsp 30.
METHODOLOGY: A1chieve is a non-interventional, six-month, observational study of 66,726 people with type 2 diabetes mellitus (T2DM), including both insulin users and non-insulin users, started on insulin detemir, insulin aspart, or BIAsp 30 in 28 countries across four continents. The present study evaluates the safety, effectiveness and HRQoL in 1,252 subjects from the Philippine cohort of the A1chieve study who were treated with BIAsp 30.
RESULTS: At baseline, the mean age, duration of diabetes and mean BMI were found to be 55.5±11.7 years, 7.2 ± 5.6 years and 25.4 ± 5.3 kg/m2, respectively. Seventy-eight percent (78%) of subjects were insulin naïve and 22% were prior insulin users. At baseline, glycemic control was poor (HbA1c = 9.9%) in the entire cohort. Overall there was a 2.7% reduction in mean HbA1c and 44.2% subjects achieved the HbA1c target of <7.0%, after 24 weeks of therapy with BIAsp 30. There were significant reductions in total cholesterol, LDL-cholesterol, triglycerides and systolic blood pressure after 24 weeks of therapy with BIAsp 30. There was no increase in the incidence of hypoglycemia among insulin-naïve subjects, while there was a marked reduction in hypoglycemia (4.93 to 2.53 events/person-year) among prior insulin users at 24 weeks.
CONCLUSION: BIAsp 30 is safe and efficacious for initiating and intensifying insulin therapy for Filipino T2DM patients.

Human ; Male ; Female ; Middle Aged ; Adult ; Insulin Aspart ; Insulin ; Diabetes Mellitus, Type 2 ; Hemoglobin A, Glycosylated ; Cholesterol, Ldl ; Triglycerides ; Insulin, Isophane

Background: The high prevalence of type 2 diabetes mellitus (T2DM) in the Philippines has burdened the health care system. Therefore, we compared the standard of care Insulin 30/70 + Insulin Glulisine (Arm B) to a traditional insulin regimen NPH Insulin + Regular Insulin (Arm A) to test the concept that both insulin regimens provide comparable effectiveness and safety in real-world practice. Methods : This is a ‘proof-of-concept,’ prospective, randomized, open label pragmatic study of 40 consecutive Filipino T2DM patients from October 2015 to June 2016. The primary endpoint was a reduction in HbA1c at 12 weeks. The secondary endpoints were changes in Fasting Plasma Glucose (FPG), Post Prandial Glucose (PPG), Capillary Blood Sugar (CBS), weight and insulin dose at 12 weeks. ANCOVA and Fisher’s exact tests were used. Results : Patients in treatment arm A showed comparable glycemic control to arm B as measured by reductions in HbA1c (2.89% vs. 2.67%; P = 0.657), FPG (65.94 vs. 46.71 mg/dl; P = 0.57), PPG (76.49 vs. 86.96 mg/dl; P = 0.271) and CBS (115.15 vs. 145.95 mg/dl; P = 0.420). Both treatment arms reported similar weight gain (1.92 vs. 1.22 kg), experienced similar incidence of hypoglycemia (7 vs. 6 patients) and adverse events (AE) (8 vs. 8 patients). Conclusion The traditional combination of NPH Insulin + Regular Insulin offers comparable glycemic control and tolerance as the standard of care without any new safety signals in the Filipino T2DM population. With a lower price, it can be one of the strategies to reduce the fi nancial burden of antidiabetic treatment.
Insulin, Isophane ; Insulin ; Diabetes Mellitus, Type 2