Phase 3 Trial For Sanofi’s Toujeo In Children And Adolescents With Type 1 Diabetes Show Positive Results
Source: Thailand Medical News Nov 05, 2019 4 years, 5 months, 2 weeks, 6 days, 2 hours, 48 minutes ago
Pharma giant
Sanofi has announced that its
Toujeo (insulin glargine 300units/mL) is effective at reducing average blood sugar (HbA1c) in children and adolescents with
type 1 diabetes, compared to insulin glargine 100units/mL (Gla-100).
In the Phase III EDITION-JUNIOR study of 463 children and adolescents over the age of six,
Toujeo met its primary endpoint of non-inferior reduction of HbA1c compared to Gla-100 after six months.
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Furthermore, fewer participants in the
Toujeo group experienced severe hypoglycaemia and hyperglycaemia with ketosis; these are both severe short-term complications for
type 1 diabetes patients, and insulin control is particularly challenging for younger patients.
The clinical study showed that 6% of the
Toujeo experienced one or more episode of
hypoglycaemia, compared to 8.8% of the Gla-100 group. In terms of hyperglycaemia, 8.2% of the
Toujeo group reported one or more event, compared to 11.4% for the control group. Participants continued to use their existing mealtime insulin during the six month study.
Dietmar Berger, Sanofi global head of development told
Thailand Medical News, “Across the globe, between 50% and 80% of young people living with
type 1 diabetes need more treatment options to help them achieve an average blood sugar level below 7.5%. By taking this step toward investigating an additional option for children and adolescents living with diabetes, we hope to provide another treatment for them and their physicians, to develop an individualized treatment plan that helps patients better manage their disease.”
Sanofi’s
Toujeo has been approved for adults with
type 1 diabetes since 2015 in the US and the European Union. As a result of the EDITION-JUNIOR data, Sanofi’s drug has been recommended for a label expansion by the European Medicines Agency’s Committee for Medicinal Products for Human Use; the European Commission is expected to make a final decision about approving
Toujeo for a younger patient population in the next few months.
The Phase 3 EDITION-JUNIOR results were presented at the International Society for Pediatric and Adolescent Diabetes 45th Annual Conference in Boston.
Sanofi presented
Toujeo’s ability to reduce the risk
of severe hypoglycaemia in adults, adolescents and children, compared to Gla-100, at both eight weeks and six months. This confirmed findings from three of
Sanofi’s Phase III EDITION studies four, JP one and JUNIOR all of which met their primary endpoints.
After eight weeks of treatment, 50% fewer patients in the
Toujeo group experienced severe hypoglycaemic events in the Toujeo group, compared to the Gla-100 group. The results were 35% fewer at six monthS.
Reference: Danne T et al., “Insulin Glargine 300 U/mL (Gla-300) provides effective glycemic control in youths with type 1 diabetes (T1D): the EDITION JUNIOR study”, Poster presentation P240, ISPAD 45th Annual Conference, Boston MA, Oct 31,2019. https://www.professionalabstracts.com/ispad2019/Iplanner/#/presentation/216
