Premix Insulin Analogue Therapy In Type 2 Diabetes : Clinical Observational Study in Routine Practice

Objective : Premixed insulin is the most widely used insulin formulation in India. The objective of our study was to evaluate and document the usage and effectiveness of the newly introduced premix insulin aspart in type 2 diabetes in routine clinical practice. Methods : The study was done prospectively at 22 diabetes care clinics across India on the use of premix insulin aspart give alone or in combination with oral antidiabetic drug (OAD) for 12-weeks. Data was collected on 371 consecutive patients with type 2 diabetes at 3 time-points-baseline, 4 weeks later and end of 12-weeks. Study measures included demogramphy, FPG (fasting plasma glucose), PPPG (postprandial Plasma glucose), HbA1c, insulin dose and weight changes. Safety measures included reported adverse drug reaction (ADR) including hypoglycaemic episodes. Results : Premix insulin aspart caused statistically reductions in FPG (66.73+47.93 mg/dl; p<0.0001), PPPG (112.8+71.7 mg/dl; p< 0.0001) and HbA1c (1.51+1.05 % p<0.0001) at the end of 12-weeks compared to baseline. There was a very small increase in weight (0.68+2.6 kg; p<0.0001) over the 12 week period. Apart from episodes of minor hpoglycamia otherwise no ADRs were reported during the study. Conclusion : We conclude that newly introduced premix insulin aspart is an effective, safe and convenient option in insulin-requiring patients with type 2 diabetes.