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.

Readers may use this article as long as the work is properly cited, the use is educational and not for profit, and the work is not altered. More information is available at http://www.diabetesjournals.org/content/license.