Objective: With increasing longevity, obesity and late insulin initiation being common in type 2 diabetes mellitus (T2DM), concentrated insulin formulations could evolve as a choice in a subgroup of these subjects. Globally, 30% of T2DM use more than 60 units of insulin daily. U200 (r-DNA Human Insulin Premix 30/70 200IU/mL) insulin has been developed to provide sustained glucose-lowering effect and enhanced compliance without increasing the risk of hypoglycaemia. This study was conducted to assess the efficacy and safety of U200 insulin in terms of 24-hour glucose profiling using Continuous Glucose Monitoring (CGM) in T2DM.
Methods: Prospective, single-arm, open-label, multi-centre study evaluating glycaemic profile in 60 adults with T2DM administered with U200 was undertaken using CGM (iPro2, Medtronic USA) for 7 days. The endpoints assessed were time spent within acceptable glycaemic range, mean amplitude of glucose excursions (MAGE), and the duration and frequency of hypo/hyper-glycaemic periods.
Results: Mean age of subjects was 55.47 ± 9.68 (26-70) years. Mean blood glucose level was 151±23.93 (105.73-231.69) mg/dl. Blood glucose levels were within the normal limits (70-150 mg/dL) for 62.35% of time. Average numbers of hyperglycaemic and hypoglycaemic episodes observed were 2.64 and 0.22 with mean duration of 165.16 and 27.35 minutes respectively. MAGE was 77.24±22.50 (37.47-153.00) mg/dl. Medication adherence rate was 100% with no adverse event other than minor hypoglycemia reported.
Discussion and Conclusion: CGM provides 24-hour profiling of glycometabolic control and identifies fluctuations. U-200 premixed insulin demonstrated low intraday variability as measured by MAGE of 77.24 mg/dl and patients spending 62.35% of time within normal glucose limits, allowing for a more constant action with less frequent hypoglycaemic or hyperglycaemic excursions. U200 human premix insulin is effective, safe and well tolerated in T2DM patients.
H. Thacker: Research Support; Self; Wockhardt LTD. J. Kesavadev: Advisory Panel; Self; Novo Nordisk India Private Limited. Speaker's Bureau; Self; Novo Nordisk India Private Limited. Advisory Panel; Self; Medtronic. Speaker's Bureau; Self; Medtronic. Advisory Panel; Self; Sanofi. Speaker's Bureau; Self; Sanofi. Research Support; Self; MSD. Speaker's Bureau; Self; MSD. Advisory Panel; Self; AstraZeneca. Speaker's Bureau; Self; AstraZeneca. G. Singh: Employee; Self; Wockhardt LTD. K. Shukla: Employee; Self; Wockhardt Ltd. G. Puppalwar: Employee; Self; Wockhardt Limited, India. R. Shrimanker: Research Support; Self; Wockhardt LTD.