November 05, 2019
3 min read
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Higher-dose insulin glargine safe, effective among children with type 1 diabetes

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Children and adolescents with type 1 diabetes assigned insulin glargine injection 300 U/mL for 26 weeks experienced a reduction in HbA1c similar to that of children assigned insulin glargine 100 U/mL, according to findings from the randomized phase 3b EDITION JUNIOR study presented at International Society for Pediatric and Adolescent Diabetes Annual Meeting.

Researchers also observed no difference in hypoglycemic events between treatment groups.

“EDITION JUNIOR demonstrated children and adolescents aged 6 to 17 years living with type 1 diabetes achieved comparable reduction in average blood glucose and similar risk of low blood sugar events with [insulin glargine 300 U/mL; Toujeo, Sanofi] compared with insulin glargine 100 U/mL,” Christopher Sorli, MD, PhD, vice president of medical affairs, head of diabetes and cardiovascular US, Sanofi, told Endocrine Today. “By taking this step toward investigating an additional option for children and adolescents living with type 1 diabetes, we hope to provide another treatment option for them and their physicians, to develop an individualized treatment plan that helps patients better manage their disease.”

Study design

EDITION JUNIOR compared the efficacy and safety of insulin glargine 300 U/mL, a second-generation basal insulin analogue, with insulin glargine 100 U/mL (Lantus, Sanofi), a first-generation analogue, among 463 children and adolescents aged 6 to 17 years with type 1 diabetes. Participants in the open-label, two-arm, parallel group trial had been treated for at least 1 year and had an HbA1c between 7.5% and 11% at screening (mean age, 13 years; mean diabetes duration, 5.6 years). Researchers randomly assigned participants to once-daily insulin glargine 300 U/mL (n = 233) or insulin glargine 100 U/mL (n = 228) for 26 weeks, followed by a 6-month safety extension period. Participants continued to use their existing mealtime insulin. Researchers used a multiple imputations approach to assess changes in HbA1c and fasting plasma glucose between baseline and 26 weeks and a negative binomial model to assess hypoglycemia event rates.

Noninferiority met

Researchers found that the study met its primary endpoint of change in HbA1c from baseline to 26 weeks, confirming a noninferior reduction in HbA1c for children assigned insulin glargine 300 U/mL vs. insulin glargine 100 U/mL at 26 weeks (mean reduction, 0.4% vs. 0.4%; 95% CI, –0.17 to 0.18). During the same period, a comparable number of patients experienced one or more anytime hypoglycemia events in each group. Numerically fewer patients using insulin glargine 300 U/mL experienced severe hypoglycemia or one or more episodes of hyperglycemia with ketosis compared with children assigned insulin glargine 100 U/mL, according to researchers.

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Adverse events were comparable between the two treatment groups, and no unexpected safety concerns were reported.

“These results are in line with other pediatric studies with insulin glargine 100 U/mL, insulin detemir and insulin degludec, highlighting that maintenance of glycemic control in these age groups is challenging, owing to variations in insulin sensitivity that are related to growth, sexual maturation and the ability to provide self-care,” the researchers wrote.

The study design includes a 6-month safety follow-up period, which will be reported separately, according to the release. The safety and efficacy of insulin glargine 300 U/mL among adolescents is under FDA regulatory review.

“Between 50% and 80% of young people living with type 1 diabetes across the globe need more treatment options to help them achieve an HbA1c below 7.5%,” Sorli said. “Additionally, living with type 1 diabetes means dealing with highs and lows of blood glucose, which are worrying and present substantial challenges for young people.”

Sorli added that hypoglycemia is a common complication of insulin therapy for children and episodes contribute to sub-optimal glycemic control and add significantly to the psychosocial burden of the disease.

“In addition, hypoglycemic unawareness is common in young adults with insulin-requiring diabetes and is associated with an increased risk of severe hypoglycemia,” Sorli said. “Prevention of hypoglycemia in children and adolescents remains a significant unmet need and an important consideration in individualizing optimal therapy for the patient, their families and their providers.”

As Endocrine Today previously reported, within the EDITION clinical trial program, researchers conducted a series of international phase 3 studies evaluating the efficacy and safety of the therapy in more than 3,500 adults with type 1 and type 2 diabetes. In open-label, randomized, active-control, parallel, treat-to-target studies, with durations up to 26 weeks and including 6-month safety extensions, investigators compared the insulin glargine injection 300 U/mL against once-daily insulin glargine injection 100 U/mL (Lantus rDNA, Sanofi). Insulin glargine 300 U/mL met the primary study endpoints in all studies, demonstrating blood glucose control similar to that of insulin glargine 100 U/mL. – by Regina Schaffer

Reference:

Danne T, et al. Poster #240. Presented at: International Society for Pediatric and Adolescent Diabetes; Oct. 30-Nov. 2, 2019; Boston.

Disclosure: Sorli is vice president of medical affairs, head of diabetes and cardiovascular US, Sanofi. Please see the poster for all other researchers’ relevant financial disclosures.