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Toujeo® reduces the rate of predicted severe low blood sugar events by 25% compa
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Pioneering Real-World Evidence in Diabetes
June 24, 2018
Background: Overcoming limitations of traditional observational studies
Real world evidence (RWE) is becoming increasingly important in informing decisions made by physicians and payers, evaluating electronic health records for broad and diverse groups of patients in a routine clinical setting to provide insights that randomized, controlled trials cannot. Sanofi’s RWE program uses sophisticated techniques to overcome limitations of traditional observational studies, reducing sources of potential bias and making results widely applicable.
With our long-standing commitment to addressing the needs of people living with diabetes, Sanofi has continued its extensive research program comparing the effectiveness of different long-acting insulins. Sanofi is presenting the following new analysis at the American Diabetes Association (ADA) 78th Scientific Sessions in Orlando, Florida, U.S.
Toujeo® reduces the rate of predicted severe low blood sugar events by 25% compared to insulin degludec
* Toujeo® reduces the rate of predicted severe low blood sugar events by 25% vs. insulin degludec in people with type 2 diabetes starting insulin therapy for the first time
* 48 to 50% reduction in the rate of predicted severe low blood sugar events with Toujeo vs. insulin detemir or insulin glargine 100 Units/mL with type 2 diabetes starting insulin therapy for the first time
Toujeo® (insulin glargine 300 Units/mL) reduces the rate of predicted severe low blood sugar (hypoglycemia) events by 25% compared to insulin degludec in adults starting to treat their type 2 diabetes with a second generation long-acting (basal) insulin. Toujeo also reduces predicted low blood sugar events compared with other long-acting insulins, insulin glargine 100 Units/mL and insulin detemir, whether patients were starting or switching insulin therapy. These results, from LIGHTNING-PM, a retrospective observational analysis of U.S. real-world data, were presented today at the American Diabetes Association (ADA) 78th Scientific Sessions in Orlando, Florida, U.S.1
“Second generation basal insulins are an effective and safe treatment option for people living with type 2 diabetes, as severe hypoglycemia is a risk that many patients are concerned about,” said Antonio Tataranni MD, Senior Vice President & Head of Medical Affairs, Diabetes and Cardiovascular, at Sanofi. “Comparative real-world studies such as LIGHTNING-PM, can help people with type 2 diabetes and their physicians to make informed treatment decisions.”
The LIGHTNING-PM study, together with previous studies from the EDITION and DELIVER programs,2–7 consistently demonstrate a reduction in hypoglycemia risk for patients with type 2 diabetes versus other first generation basal insulins. The lower risk of hypoglycemia versus insulin glargine 100 Units/mL has been confirmed in multiple clinical trials.2 Studies have also demonstrated the more stable profile of Toujeo versus insulin glargine 100 Units/mL, and the flatter profile with fewer within-day fluctuations of Toujeo versus insulin degludec.8
About the LIGHTNING-PM Study
LIGHTNING-PM, a large, retrospective, comparative real-world 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 (p<0.05) with Toujeo (Gla-300) versus insulin degludec (IDeg), and 48% and 50% lower rates compared with patients starting treatment with insulin glargine 100 Units/mL (Gla-100) and insulin detemir (IDet), respectively (p<0.05 for both comparisons).1
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 (p<0.05 for both comparisons).1
Predicted rates of severe hypoglycemia
* p<0.05 for Gla-300 vs BI comparator
1. Meneghini L et al., “Comparable Rates of Severe Hypoglycemia in People with Type 2 Diabetes (T2DM) at High Risk of Hypoglycemia Switching to either Insulin Glargine 300 U/mL (Gla-300) or Insulin Degludec (IDeg)—The Lightning Real-World Predictive Modeling Study” Poster 97-AB, American Diabetes Association (ADA) 78th Scientific Sessions, June 25, 2018, Orlando, Florida, U.S..
2. Ritzel R, et al., Diabetes Obes Metab. 2015;17(9):859–867, DOI: 10.1111/dom.12485
3. Ye. F et al., Abstract 943-P presented at the American Diabetes Association 76th Scientific Sessions, New Orleans Louisiana, June 10–14, 2016
4. Zhou FL et al., Poster NR 1151, American Association of Clinical Endocrinologists (AACE) 26th Annual Scientific & Clinical Congress, Austin, TX, U.S., May 3–7, 2017
5. Zhou FL et al., Poster 986-P presented at American Diabetes Association (ADA) 77th Scientific Sessions, San Diego, CA, U.S. June 9–13, 2017
6. Blonde L et al., "Real-world evidence demonstrates comparable clinical outcomes of switching from insulin glargine 100 U/mL (Gla-100) to insulin glargine 300 U/mL (Gla-300) vs insulin degludec (IDeg) in patients with type 2 diabetes (T2D)", World Congress on Insulin Resistance, Diabetes & Cardiovascular Disease in Los Angeles, CA, U.S., November 30 – December 2, 2017
7. Zhou FL et al., "Hypoglycemia risk associated with basal insulin use in type 2 diabetes (T2DM): The Lightning study", World Congress on Insulin Resistance, Diabetes & Cardiovascular Disease in Los Angeles, CA, U.S., November 30 – December 2, 2017
8. Bailey et al. Insulin Glargine 300 U/mL (Gla-300) Provides More Stable and More Evenly Distributed Steady-state PK/PD Profiles Compared with Insulin Degludec in Type 1 Diabetes. Presented at Diabetes Technology Meeting, November 11 2016
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.
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 Communciitions
Tel.: +33 (0) 6 75 71 61 24
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