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OBJECTIVE: Our objective was to investigate willingness to pay (WTP) for biphasic insulin aspart 30/70 (BIAsp 30) in patients with type 2 diabetes mellitus (T2DM) in India. METHODS: A multicenter, prospective, non-interventional, preference study was conducted that assessed WTP for BIAsp 30 in an insulin pen (FlexPen® or Penfill® device) in patients in India with T2DM previously treated with biphasic human insulin (BHI) in vials and believed to be able to pay for treatment. The primary endpoint was the proportion of patients willing to continue to pay for BIAsp 30 after 12 weeks' treatment. Secondary endpoints included the change from baseline in treatment and device satisfaction and patient preferences for treatment attributes as assessed by a nested discrete-choice experiment. RESULTS: Overall, 54.9% (n = 277/505) of participants were male; the mean age was 56.4 years; diabetes duration was 10.9 years; 63.8% had a body mass index ≥ 25 kg/m2; > 75% had an annual household income > 150,000 Indian rupees (INR). After 12 weeks' treatment, 96.4% of patients were willing to pay for BIAsp 30. Mean treatment and device satisfaction significantly improved from baseline (p < 0.0001). Patients were willing to pay INR3576 (95% confidence interval [CI] 2755-4398) for improved glycemic control, INR688 (95% CI 383-994) for a device upgrade (vial/syringe to an insulin pen), or INR327 (95% CI 95-560) to avoid major hypoglycemia. Patients would need to be compensated INR44 (95% CI 56-32) per minor hypoglycemic event. CONCLUSIONS: In India, patients with T2DM previously treated with BHI were willing to pay for BIAsp 30 in an insulin pen. Furthermore, treatment and device satisfaction improved after this therapeutic switch. TRIAL REGISTRATION: ClinicalTrials.gov: NCT03374774.
RESUMO
Objective: Zinc transporter 8 (ZnT8) is a multi-transmembrane protein situated in the insulin secretory granule of the islets of ß-cells and is identified as a novel auto-antigen in type 1 diabetes (T1D). The gene coding for ZnT8, solute carrier family 30 member 8 (SLC30A8) is located on chromosome 8q24.11. This study aimed to identify the association of SLC30A8 rs13266634 C/T gene polymorphism with T1D in a sample of T1D children in Tamil Nadu, India. Methods: The family based study was conducted in 121 T1D patients and 214 of their family members as controls. The SLC30A8 gene rs13266634 C/T polymorphism was evaluated by polymerase chain reaction-restriction fragment length polymorphism. Results: No significant differences were observed in either allele (odds ratio: 0.92; confidence interval: 0.33-2.58; p=0.88) and genotype (CC: p=0.74; CT: p=0.82; TT: p=0.80) frequencies of rs13266634 C/T between T1D patients and controls. Transmission disequilibrium test has identified over-transmission of mutant T allele from parents to affected children (T: U=9:7) without statistical significance. Metaanalysis on the overall effects of rs13266634 C allele frequency was not different (p=0.10 and Pheterogeneity=0.99) in T1D patients as compared to the controls. Conclusion: The present study along with the meta-analysis does not show any substantial association of the rs13266634 C/T polymorphism with T1D development in this population.