Lower Risk of Hypoglycemia after Switch to Insulin Glargine 300 U/Ml (Gla-300) Vs Other Basal Insulins in Patients with Type 2 Diabetes (T2D) on Basal Insulin in Real-World Clinical Settings (DELIVER 2 study)

Presentation Number: LB SUN 81
Date of Presentation: April 2nd, 2017

Fang Liz Zhou*1, Fen Ye1, Vineet Gupta2, Rishab Gupta2, Rishi Agarwal2, Jukka Westerbacka3, Paulos Berhanu1 and Lawrence Blonde4
1Sanofi US, Inc., Bridgewater, NJ, 2Accenture, Florham Park, NJ, 3Sanofi, Paris, France, 4Ochsner Medical Center, New Orleans, LA

Abstract

In the randomized controlled EDITION trials, Gla-300 demonstrated comparable glycemic control to insulin glargine 100 U/mL, but with less hypoglycemia. This study examined the performance of Gla-300 in real-world clinical settings. The aim was to evaluate clinical outcomes of patients with type 2 diabetes (T2D) using basal insulin who switched to either Gla-300 or other basal insulins in real-world clinical practice. The DELIVER 2 retrospective observational study used data from the Predictive Health Intelligence Environment database of real-world electronic medical records (representing 26 integrated health delivery networks). Included patients were adults with T2D using basal insulin, with data for 12 months prior to (baseline) and up to 6 months after (follow-up) switching to either Gla-300 or other basal insulins (index date: March 1, 2015 through February 29, 2016). All patients had glycated hemoglobin (A1C) levels measured < 6 months prior to index date and > 90 days after. The endpoints were A1C change, incidence and rate of hypoglycemia, and patient proportions reaching target A1C < 7.0% and < 8.0%. Following a 1:1 ratio propensity score matching, 947 patients who switched to Gla-300 and 947 patients who switched to other basal insulins were identified. Mean baseline A1C levels were 8.89% and 8.92%, which significantly decreased to 8.42% and 8.50% (P < 0.001 for both) 6 months after switching to Gla-300 or other basal insulins, respectively. A1C reductions were comparable in both cohorts (−0.48% for Gla-300 vs −0.41% for other basal insulins; P=0.44). Significantly fewer patients who switched to Gla-300 experienced hypoglycemia vs those who switched to other basal insulins at 6-month follow-up (incidence: 15.1% vs 19.9%, respectively; P=0.03). Adjusted for baseline hypoglycemia, switching to Gla-300 compared to other basal insulins was associated with a significantly lower hypoglycemia event rate at 6 months (difference between least squares means: 2.67 events/100 patient-months, P=0.001), and significantly lower incidence and event rates of hypoglycemia requiring hospitalization or emergency care. Significantly lower hypoglycemia was also seen at 3 months of follow-up in the Gla-300 switchers. At 6 months of follow-up, patients on Gla-300 and those on other basal insulins were equally likely to reach A1C < 7.0% (16.9% vs 18.7%, respectively; P=0.35) and A1C < 8.0% (45.0% vs 42.0%, respectively; P=0.31). In real-world clinical settings, switching to Gla-300 is associated with a significantly lower risk of hypoglycemia than switching to other basal insulins, while delivering comparable glycemic control.

 

Disclosure: FLZ: Employee, Sanofi. FY: Employee, Sanofi. VG: Coinvestigator, Sanofi. RG: Coinvestigator, Sanofi. RA: Coinvestigator, Sanofi. JW: Employee, Sanofi. PB: Employee, Sanofi. LB: Ad Hoc Consultant, Sanofi.