Sanofi's Toujeo® Demonstrated a Consistently Lower Rate of Hypoglycemia Compared to Lantus® at All Levels of HbA1c control

- Benefits on adherence and HbA1c to be validated in a real-world setting -

PARIS, Sept. 13, 2016 /CNW/ - 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 the person as well as their treating physician'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.

About EASD abstract 

The meta-analysis was performed on patient-level data from the EDITION 1, 2 and 3 phase 3 clinical trials (n=2,103). Annualized rate of confirmed (≤3.9 mmol/L or ≤70.2 mg/dL) or severe hypoglycemia rate (events per participant-year) was correlated with HbA1c data at month 6 for each patient, using a negative binomial regression model. There was no overlap between the curves for Toujeo® (insulin glargine 300 Units/mL) and Lantus® (insulin glargine 100 Units/mL), demonstrating that the hypoglycemia rate was lower with Toujeo® than with Lantus® at all levels of HbA1c.

The presentation is titled: "Hypoglycaemia as a function of HbA1c in type 2 diabetes (T2DM): insulin glargine 300 U/ml in a patient-level meta-analysis of EDITION 1, 2 and 3" (Choudhary P, et al. Oral presentation #10, European Association for the Study of Diabetes (EASD) 52nd Annual Meeting, Munich, Germany, September 13, 2016).

About patient-level information from the PHIE database 

Adults with type 2 diabetes who had used other basal insulins within the 6 months prior to Toujeo initiation (one or more prescription orders of Toujeo® between March 2015 and December 2015) were identified. The PHIE records of those identified (n=881) were assessed for HbA1c and incidence of confirmed (≤3.9 mmol/L or ≤70.2 mg/dL) or severe hypoglycemia up to 6 months prior to and up to 6 months after initiation.

Among the subpopulation of patients (n=267) with HbA1c measured at baseline and during follow-up (0-6 months), mean HbA1c was 8.97% at baseline and 8.33% at follow-up. For the subpopulation of patients (n=449) with occurrence of hypoglycemia reported at baseline and during follow-up (0-3 months), this was 6.0% at baseline and 5.1% at follow-up.

The poster is titled "Real-World Assessment of Patient Characteristics and Clinical Outcomes of Early Users of the New Insulin Glargine 300U/mL" (Ye F, et al. Poster presentation 943-P, New Orleans, LA, U.S., Saturday, June 11, 2016).

About ACHIEVE, REACH and REGAIN CONTROL 

The ACHIEVE CONTROL study will evaluate the effect of Toujeo® versus other basal insulins in a real-life setting on achieving individualized glycemic targets without hypoglycemia at any time of day in 3,270 uncontrolled insulin-naïve people in the U.S. with type 2 diabetes.

The REACH CONTROL will follow 920 insulin-naïve people with type 2 diabetes in Europe, comparing HbA1c change with Toujeo® versus other basal insulins, alongside incidence of hypoglycemia, change in body weight, and measures of persistence with treatment and need for treatment intensification in a real-life setting.

The REGAIN CONTROL study will compare HbA1c reduction, incidence of hypoglycemia, change in body weight and persistence with treatment on Toujeo® versus other basal insulins in 800 people with type 2 diabetes in Europe, who are currently uncontrolled on basal insulin in a real-life setting. In addition to clinical measures, the studies will also collect patient feedback on treatment satisfaction and their experience of hypoglycemia, along with healthcare resource utilization.

About Toujeo® 

Toujeo® is a once-daily basal insulin based on a broadly-used molecule (insulin glargine). Toujeo has been approved by the U.S. Food and Drug Administration (FDA), the European Commission, Health Canada, the Therapeutic Goods Administration in Australia, and the MHLW in Japan (where its approved brand name is Lantus® XR), and is under review by other regulatory authorities around the world.

About Sanofi 

Sanofi, a global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients' needs. Sanofi is organized into five global business units: Diabetes and Cardiovascular, General Medicines and Emerging Markets, Sanofi Genzyme, Sanofi Pasteur and Merial. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).

Sanofi Forward-Looking Statements 

This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words "expects", "anticipates", "believes", "intends", "estimates", "plans" and similar expressions. Although Sanofi's management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the absence of guarantee that the product candidates if approved will be commercially successful, the future approval and commercial success of therapeutic alternatives, Sanofi's ability to benefit from external growth opportunities and/or obtain regulatory clearances, risk associated with intellectual property and any related pending or future litigation and the ultimate outcome of such litigation, trends in exchange rates and prevailing interest rates, the impact of cost containment initiatives and subsequent changes thereto, the average number of shares outstanding as well as those discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under "Risk Factors" and "Cautionary Statement Regarding Forward-Looking Statements" in Sanofi's annual report on Form 20-F for the year ended December 31, 2015. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.

SOURCE SANOFI


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