Sanofi Diabetes Update: New evidence reinforces favorable profile of Toujeo October 2, 2018

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1 Sanofi Diabetes Update: New evidence reinforces favorable profile of Toujeo October 2, 2018 Background: For people with diabetes the early months of treatment with long-acting insulin are important for adherence and long-term outcomes People with diabetes who experience low blood sugar events (hypoglycemia) during the first few months of treatment with basal insulin, tend to use more healthcare resources and are more likely to stop treatment than those who don t. 1 Hypoglycemia can have a huge impact on people with diabetes and is associated with a high cost for healthcare systems and society. 2 Fear of hypoglycemia by HCPs and patients can result in sub-optimal dosing, 3 which can lead to serious long-term health complications. Most dose adjustment is done, and most improvement in blood sugar control is achieved, in the early period of treatment, called the titration period. 4 It is therefore important to ensure that people with diabetes requiring insulin get off to a good start and prevent lapses in treatment, or stopping it altogether. Sanofi explored the benefit of Toujeo in Randomized Controlled Trials and Real World Evidence (RWE) to give a broad picture of how the treatment truly affects people with diabetes starting basal insulin therapy.

2 Across studies, Toujeo provides the same or lower risk of low blood sugar vs insulin degludec in people with type 2 diabetes starting insulin treatment In the first head-to-head randomized controlled trial comparing efficacy and safety of second-generation basal insulins, Toujeo meets primary endpoint showing similar blood sugar control vs insulin degludec This study, called BRIGHT published in Diabetes Care, also shows reductions in incidence and rate of low blood sugar events in the first 12 weeks of treatment LIGHTNING PM, a large RWE study, indicated a trend for Toujeo to reduce the rate of predicted low blood sugar events vs. insulin degludec in people with type 2 diabetes starting insulin therapy Sanofi has presented two types of analysis, a Randomized Controlled Trial (RCT), BRIGHT, and a Real World Evidence (RWE) study, LIGHTNING PM. The separate studies, using different methodologies, showed similar or better results for their second-generation basal insulin, Toujeo (insulin glargine 300 Units/mL) compared to insulin degludec 100 Units/mL. Both studies have been presented at the European Association for the Study of Diabetes (EASD), 54th Annual meeting in Berlin, Germany. 5,6 The BRIGHT head-to-head study showed comparable blood sugar (HbA1c) control with Toujeo versus insulin degludec. During the first 12 weeks of therapy (titration period) Toujeo reduced the rate and the incidence of confirmed ( 70 mg/dl) low blood sugar events by 23 percent and 26 percent respectively compared to insulin degludec. 7 During the latter 12 weeks of the study (maintenance period: weeks), the two treatments showed comparable incidence and rate of low blood sugar events. 5 Hypoglycemia is a concern across the board for people with diabetes, HCPs and national health services, said Alice Cheng, Associate Professor of Endocrinology, University of Toronto, Toronto, Canada and primary investigator of the BRIGHT study. We know experiencing hypoglycemic events is a particularly challenging problem for patients new to basal insulin. The LIGHTNING PM RWE study showed that Toujeo predicted a trend for reduced rate of severe low blood sugar events by 25 percent vs. insulin degludec in adults with type 2 diabetes starting insulin therapy. The study

3 also predicted reductions versus two first generation basal insulins (insulin detemir and insulin glargine Units/mL). 6 Results of the BRIGHT study: The randomized controlled trial compared the efficacy and safety of Toujeo versus insulin degludec at 24 weeks. The study randomized 929 adults with type 2 diabetes to once-daily Toujeo or insulin degludec 100 Units/mL. Before randomization, participants were inadequately controlled with tablets (oral anti-hyperglycemic drugs, OADs), with or without a glucagon-like peptide-1 (GLP-1) receptor agonist and had not previously started insulin therapy. 5 The study met its primary endpoint demonstrating a reduction in blood sugar (HbA1c) levels comparable with Toujeo and insulin degludec from baseline to week 24 (at a non-inferiority margin of 0.3% and difference between treatments of -0.05% [95% CI 0.15 to 0.05%] p< for non-inferiority). 4 Over the 24-week period, incidence and event rates of confirmed ( 70 mg/dl and 54 mg/dl) low blood sugar at any time of day were comparable between Toujeo and insulin degludec 100 units/ml. During the titration period (0-12 weeks), confirmed low blood sugar event rates were lower by 23 percent ( 70 mg/dl) and 43 percent ( 54 mg/dl). In this period, the incidence of confirmed low blood sugar was also reduced by 26 percent ( 70 mg/dl) and 37 percent ( 54 mg/dl). Low blood sugar incidence and event rates were comparable in the maintenance time period (13-24 weeks). 7

4 Results of the LIGHTNING PM study: LIGHTNING PM, a large, retrospective, comparative RWE study, evaluated electronic medical records of 112,626 adult patients in the U.S. who were treated with long-acting insulins. Predictive modeling, involving machine learning, was used to separate the initial patient population into individual treatment groups. This process controlled for more than 160 patient-related factors that were validated for each patient group. In insulin-naïve patients (n=70,625 patient treatments per insulin), the data predicted a 25% lower rate of severe hypoglycemia with Toujeo (Gla-300) versus insulin degludec (IDeg) (7.4 vs 9.9 events per 100 patient-years). Rates of severe hypoglycemia were 48% and 50% lower with Gla-300 compared with patients starting treatment with insulin glargine 100 Units/mL (Gla-100) and insulin detemir (IDet), respectively (7.4 vs 14.1 and 14.8 events per 100 patient-years). 6 For patients switching basal insulin treatment (n=42,001 patient treatments per insulin), the analysis predicted a similar rate with Toujeo compared with insulin degludec, and reductions of 21% and 29% compared with insulin glargine 100 Units/mL and insulin detemir (21 vs 26.5 and 29.7 events per 100 patient-years, respectively). 4

5 Predicted rates of severe hypoglycemia 6 * p<0.05 (one-tailed) for Gla-300 vs BI comparator References 1. Dalal A et al., Adv Ther (2017) 34: DOI /s x. 2. Greco D, Angileri G. Diabetes Nutr Metab. 2004; 17(1): Russell Jones D et al. Diabetes Obes Metab. 2018;20: Owens DR, et al. Diabetes Res Clin Pract. 2014;106: Cheng A, et al. Similar Glycemic Control and Less or Comparable Hypoglycemia with Insulin Glargine 300 U/mL (Gla-300) vs Degludec 100 U/mL (IDeg-100) in Insulin-Naïve T2DM on Antihyperglycemic Drugs ± GLP-1 RAs: The BRIGHT Randomized Study. Presentation 80, European Association for the Study of Diabetes (EASD) 54th annual meeting in Berlin, Germany, Oct 3, Available via [Accessed September 2018]. 6. Berria R et al., Similar or lower severe hypoglycemia rates with Gla-300 vs Gla-100, IDet and IDeg in 112,626 people with type 2 diabetes: predictive modelling using real-world data: Lightning. Poster 899, European Association for the Study of Diabetes (EASD) 54th annual meeting in Berlin, Germany, Oct 4, Available via hypoglycaemia-rates-with-gla-300-vs-gla-100-idet-and-ideg-in people-with-type-2- diabetes-predictive-modelling-using-real-world-data-lightning [Accessed September 2018]. 7. Bolli GB, et al. Lower Hypoglycemia Rates with Insulin Glargine 300 U/mL (Gla-300) vs Insulin Degludec 100 U/mL (IDeg-100) in Insulin-Naïve Adults with T2DM on Oral Antihyperglycemic Therapy ± GLP-1 RA: The BRIGHT Randomized Study. Presentation 896, European Association for the Study of Diabetes (EASD) 54th annual meeting in Berlin, Germany, Oct 4, Available via [Accessed September 2018]. About Sanofi Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

6 With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Sanofi, Empowering Life Global Diabetes Communications Serge Spierckel Tel.: +33 (0) serge.spierckel@sanofi.com ####