Paris, France: Sanofi announced today that adults with type 2 diabetes treated with Toujeo® (insulin glargine 300 Units/mL) experienced a consistently lower rate of confirmed or severe hypoglycemia both at night and at any time of the day compared with those treated with Lantus® (insulin glargine 100 Units/mL), at all levels of HbA1c (average blood glucose over the previous three months) achieved at month 6. The results of this new patient-level meta- analysis from the EDITION 1, 2 and 3 Phase 3 clinical trials in patients with type 2 diabetes were presented at the 52nd Annual Meeting of the European Association for the Study of Diabetes (EASD) in Munich, Germany.
“For people with diabetes, it is vital to achieve good glycemic control in order to minimize the risk of microvascular complications. Risk of hypoglycemia can be an important factor in a person’s attitude towards treatment of their diabetes, and can lead to improved adherence and reduced glycemic control in real-world conditions,” said Pratik Choudhary, Senior Lecturer and Consultant in Diabetes, Kings College London, UK and lead author of the presentation. “These results show that in more than 2,000 patients that Toujeo could enable adults with type 2 diabetes to achieve equivalent glycemic control with less hypoglycemia vs. Lantus. We look forward to the validation of these important findings in real-world settings.”
In addition, the first clinical evidence in a real life setting to reflect the possibility of achieving glycemic control with fewer hypoglycemic events was presented at the American Diabetes Association (ADA) 76th Scientific Sessions. Those data were drawn from existing patient-level information (from the Predictive Health Intelligence Environment database) on patients switching to Toujeo from other basal insulins under real-life conditions. The results demonstrated that patients treated with Toujeo experienced a mean estimated reduction in HbA1c of 0.64% (p<0.0001) after 6 months of treatment, while the occurrence of hypoglycemia was 6.0% at baseline and 5.1% at follow-up.
“These encouraging meta-analysis findings, in combination with preliminary patient-level data from a real-life setting, provide useful information about Toujeo’s potential to help people with diabetes achieve better glycemic control without additional risk of hypoglycemia,” said Riccardo Perfetti, Head of Global Diabetes Medical Team, Sanofi. “We are currently conducting a broad real-world clinical program to confirm these findings.”
Sanofi is conducting three large, randomized clinical trials - ACHIEVE, REACH and REGAIN CONTROL - evaluating in real-life conditions the effect of Toujeo in people with type 2 diabetes. These trials will provide an important evaluation of the effectiveness of Toujeo’s disease- management strategy, that could be particularly relevant to healthcare professionals, diabetes educators and payers.
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