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Key publication slides Aronson R, et al. Sustained efficacy of insulin pump therapy compared with multiple daily injections in type 2 diabetes: 12-month data from the OpT2mise randomized trial. Diabetes, Obesity and Metabolism. 2016;18:500-7. Key publication slides No FXCX

Background and Objectives Only about one-half of patients with T2D requiring intensive insulin therapy will achieve HbA1c targets using a basal−bolus MDI regimen1 Whether the use of insulin pump therapy improves glycaemic control compared with MDI in patients with T2D is unclear2–5 In a randomized, 12-month study (OpT2mise trial), the efficacy and safety of pump therapy was compared with that of MDI in patients with T2D6 After 6 months, pump therapy was associated with a significant reduction in HbA1c vs MDI, with a 20% reduction in total daily insulin dose7,8 In this article, the full 12-month results of the OpT2mise trial are reported9 1. Riddle MC, et al. Diabetes Obes Metab. 2014;16:396-402. 2. Berthe E, et al. Horm Metab Res. 2007;39:224-9. 3. Wainstein J, et al. Diabet Med. 2005;22:1037-46. 4. Herman WH, et al. Diabetes Care. 2005;28:1568-73. 5. Raskin P, et al. Diabetes Care. 2003;26:2598-603. 6. Aronson R, et al. Diabetes Technol Ther. 2014;16:414-20. 7. Reznik Y, et al. Lancet. 2014;384:1265-72. 8. Conget I, et al. Diabetes Technol Ther. 2016;18:22-8. 9. Aronson R, et al. Diabetes Obes Metab. 2016;18:500-7. HbA1c, glycated haemoglobin A1c; MDI, multiple daily injection; T2D, type 2 diabetes.

Study Design Randomized, parallel-group international trial 331 patients randomized to pump therapy or MDI therapy for 6 months (randomization phase) After 6 months, pump patients continued to receive pump therapy, and MDI patients crossed over to pump therapy for 6 months (continuation phase) Patients with T2D Age 30–75 years HbA1c 8.0–12.0% Treated with MDI (≥ 3 basal−bolus injections/day) for ≥ 3 months Pump therapy for 6 months Pump therapy for 6 months MDI therapy for 6 months Aronson R, et al. Diabetes Obes Metab. 2016;18:500-7.

Results: Patient Characteristics Characteristica Pump therapy (n = 168) MDI therapy (n = 163) Age, years 55.5 56.4 Male, % 56 53 Female, % 44 47 Body weight, kg 97.3 94.9 Body mass index, kg/m2 33.5 33.2 Duration of diabetes, years 14.9 15.3 HbA1c, % 9.0 Metformin use, % 71 69 Baseline patient characteristics were well-balanced between the 2 treatment groups aData are mean, except for gender proportions and metformin use. Aronson R, et al. Diabetes Obes Metab. 2016;18:500-7.

Results: Reduction in HbA1c Switch from MDI to pump Change from 6 months: −0.8% ± 1.2% (p < 0.0001) Treatment difference at Month 6 (95% CI): −0.7% [−0.9; −0.4]; p < 0.001 Change from baseline: −1.2% ± 1.1% (p < 0.0001) Mean HbA1c at baseline was 9.0% in both groups At Month 6, reduction in HbA1c was significantly greater with pump therapy than with MDI therapy At Month 12, improvement in HbA1c was maintained in the pump therapy group Further improvement in HbA1c was seen in the MDI group after they switched to pump therapy Mean HbA1c at Month 12 was 7.8% in both groups CI, confidence interval. Aronson R, et al. Diabetes Obes Metab. 2016;18:500-7.

Results: Total Daily Insulin Dose1,2 Switch from MDI to pump 19% reduction from baseline1 20% reduction from baseline1 Treatment difference at Month 6: 97 ± 56 U vs 122 ± 68 U (p < 0.0001)2 Total daily insulin dose decreased by 20% in the pump therapy group Total daily insulin dose decreased by 19% in the MDI group after switching to pump therapy Total daily insulin dose at Month 12 was similar in both groups 1. Aronson R, et al. Diabetes Obes Metab. 2016;18:500-7. 2. Reznik Y, et al. Lancet. 2014;384:1265-72. U, units.

Results: Tolerability Severe hypoglycaemia occurred in: 1 patient in the randomization phase (MDI group) 2 patients in the continuation phase 1 from pump therapy group 1 from MDI group (2 episodes) No ketoacidosis was reported Weight gain was similar in both treatment groups (2.1 kg in the pump therapy group vs 2.3 kg in the MDI therapy group) Aronson R, et al. Diabetes Obes Metab. 2016;18:500-7.

Conclusions Pump therapy provided durable glycaemic control for patients with T2D requiring intensive insulin therapy in the randomized 12-month OpT2mise trial Compared with MDI therapy, pump therapy provided sustained reductions in HbA1c while using a lower total daily insulin dose The benefits of pump therapy were confirmed in the MDI group, which experienced similar reductions in HbA1c and total daily dose after switching to pump therapy Aronson R, et al. Diabetes Obes Metab. 2016;18:500-7.