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

Allergic reaction to insulin is mediated by several mechanisms; differences in amino acid sequence of animal and human insulin, altered tertiary structure of insulin and the presence of non-insulin protein contaminants or pharmaceutical additives. Anaphylactic reactions to insulin only occur in 0.1 to 2% of patients who stopped insulin therapy and have then resumed treatment. We report a diabetic patient who suffered severe anaphylactic reactions to human recombinant insulin, successfully treated by desensitization. A 19-year-old man with type 1 diabetes receiving Insulatard HM(R) developed generalized urticaria and angioedema with progression to dyspnea, dizziness and syncope. Skin prick test to all kinds of human recombinant insulin products revealed immediate type hypersensitivity and the titer of insulin IgE was increased in serum. The desensitization trial with Velosulin HM(R) using modified desensitization method was performed. Six months after the desensitization he was taking Velosulin HM(R) as well as Insulatard HM(R) without any evidence of systemic allergic reactions.
Amino Acid Sequence ; Anaphylaxis* ; Angioedema ; Animals ; Dizziness ; Dyspnea ; Humans* ; Hypersensitivity ; Immunoglobulin E ; Insulin* ; Insulin, Regular, Pork ; Skin ; Syncope ; Urticaria ; Young Adult ; Isophane Insulin, Human