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Toujeo® DELIVER Naïve D Sanofi Diabetes Update
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Sanofi Diabetes Update:

For people with type 2 diabetes, starting insulin treatment with a second-generation basal insulin may reduce barriers to adherence

November 19, 2018

Background: Experiencing low blood sugar events can lead people to stop or disrupt their insulin treatment

People with diabetes have a need for treatments that limit periods with high blood sugar, while also minimizing low blood sugar events. A severe low blood sugar event requires help from someone else. Experiencing one such event, particularly in the early months after beginning insulin treatment, can have an important psychological impact. This might reduce the patient’s motivation to stick to their prescribed treatment plan and could even lead them to stop treatment altogether.1 Either of these decisions may have a substantial impact on their long-term health outcomes.

With its long-standing commitment to addressing the needs of people with diabetes, Sanofi has continued its extensive research program comparing the efficacy and effectiveness of different long-acting insulins. This program includes both randomized controlled trials and more innovative analyses of data collected in different real-world settings, to provide a more accurate picture of what physicians might see in routine care.

Toujeo® demonstrated comparable blood sugar control, low blood sugar events and rate of treatment discontinuation versus insulin degludec

Retrospective, real-world study of adults starting long-acting insulin treatment for type 2 diabetes

For patients starting treatment with long-acting insulin, second generation basal insulin Toujeo® (insulin glargine 300 units/mL) provides similar blood sugar reduction compared to insulin degludec (100 or 200 units/mL). Patients reported comparable rates of low blood sugar (hypoglycemia) and low blood sugar events associated with hospitalization or Emergency Department admission (severe hypoglycemia) with both treatments.

These results come from the DELIVER Naïve D retrospective, comparative, observational study analyzing U.S. electronic medical records, which was presented at the American Diabetes Association 2018 Research Symposium. 2

“Making a positive start using basal insulin is vital to encourage continuation of treatment, giving the best opportunity for beneficial longer-term outcomes,” said Rachele Berria, Head of Global Diabetes Medical Affairs at Sanofi. “DELIVER Naïve D demonstrates the contribution Toujeo can bring, as a second- generation basal insulin, to support a successful start in insulin therapy. The trend toward fewer hypoglycemic events requiring hospital visit with second generation basal insulins may also suggest differences in the overall cost of care.”

Incidence of low blood sugar events associated with hospitalization was comparable and low (2.5% of patients or fewer) in both groups. This confirms previous clinical trial findings of low risk of severe hypoglycemia in patients starting basal insulin treatment.3-5 Similar proportions of patients in both groups discontinued treatment during the analysis period.

DELIVER Naïve D follows BRIGHT, the first head-to-head randomized controlled trial comparing the efficacy and safety of Toujeo vs insulin degludec 100 units/mL in 929 adults starting insulin treatment for type 2 diabetes.3,4 BRIGHT showed similar reductions in average blood sugar measurement (HbA1c) with both treatments, with similar hypoglycemia incidence and event rates throughout the 24-week study period,3 and lower rates in the first 12 weeks, when most dose adjustment is done and most improvement in blood sugar control is achieved.6 A pharmacokinetic/ pharmacodynamic study has also demonstrated the flatter profile with fewer within-day fluctuations of Toujeo versus insulin degludec 100 units/mL.7

About the DELIVER Naïve D Study2

The DELIVER Naïve D retrospective, observational study analyzed electronic medical records, from the U.S. Predictive Health Intelligence Environment (PHIE) database (IBM Explorys data). The study assessed records for adults with type 2 diabetes who started basal insulin treatment with either Toujeo or insulin degludec (100 units/mL or 200 units/mL), in a real-world setting. It included people who had used oral anti-hyperglycemic medication (OADs) or a GLP-1 receptor agonist, and had not used any kind of insulin, in the year before starting basal insulin.

The study used propensity score matching to provide accurate comparisons between groups and avoid the possible influence of confounding factors. Participants were matched on main baseline demographic and clinical characteristics to produce an overall study population of 1,276 people. Only patient records with complete data were included in the matching process, to minimize confounding and ensure that results were based on measured data, rather than interpolations or modeling.

After 90-180 days of treatment, people using Toujeo achieved a 1.67% reduction in average blood sugar from baseline (HbA1c, p<0.0001) while those using insulin degludec had an average reduction of 1.58% (p<0.0001; difference: 0.09%, p=0.509).

Low blood sugar (hypoglycemia) outcomes were similar between groups. Fewer people using Toujeo experienced hypoglycemia and hypoglycemia requiring a hospital visit, although these differences were not statistically significant. The study compared only events that were recorded in electronic medical records. Additional hypoglycemic events in both groups may not have been reported by patients.

Similar proportions of patients in both groups discontinued treatment during the analysis period (Toujeo 29.15% vs insulin degludec 32.60%; adjusted HR 0.86; 95% CI 0.71 to 1.05 p=0.14, not significant).

The safety profiles of Toujeo and insulin degludec were consistent with previous publications.

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