Jardiance® improves blood sugar control in type 2 diabetes
Posted: 7 December 2022 | Catherine Eckford (European Pharmaceutical Review) | No comments yet
A Phase III trial showed Jardiance® is the first SGLT2 inhibitor to significantly reduce average blood sugar in type 2 diabetics aged 10-17 compared to placebo.
Jardiance® (empagliflozin) reduced HbA1c (a marker of average blood sugar) by 0.84 percent when used alongside other baseline treatments (diet, exercise, metformin and/or insulin), compared with placebo in a Phase III clinical trial of children and adolescents aged 10-17 years with type 2 diabetes.
The results indicated HbA1c reduced to these levels at week 26 (95 percent confidence interval (CI) –1.50 to –0.19; P=0.012). Boehringer Ingelheim and Eli Lilly and Company announced results of the study at the 2022 International Diabetes Federation (IDF) World Diabetes congress.
The Phase III study of Jardiance® (empagliflozin)
The DINAMO (DIabetes study of liNAgliptin and eMpagliflozin in children and adOlescents) trial (NCT03429543) included youth aged 10-17 years with type 2 diabetes and HbA1c ≥6.5 percent and ≤10.5 percent. Of the 262 participants screened, 158 were randomly assigned to treatment with empagliflozin (10 or 25mg) (n=52), linagliptin (5mg) (n=53) or placebo (n=53) once per day.
A secondary endpoint from the study indicated that at week 26, Jardiance® lowered fasting plasma glucose (–35.2mg/dL; P=0.0035).
The overall safety data was largely consistent with prior findings in adults with type 2 diabetes, confirming the safety profile of both Jardiance® (empagliflozin) and Trajenta® (linagliptin), an oral medicine for type 2 diabetes.
Participants treated with linagliptin did not show a statistically significant reduction in HbA1c when compared with placebo, with the data demonstrating a decrease of 0.34 percent (P=0.2935).
Dr Lori Laffel, Principal Investigator of the DINAMO study and Chief of the Paediatric, Adolescent, and Young Adult Section at the Joslin Diabetes Center and Professor of Paediatrics at Harvard Medical School shared: “[The] results from the DINAMO global clinical trial demonstrated that the SGLT2 inhibitor empagliflozin compared with placebo significantly improved overall blood sugar control in children and adolescents with type 2 diabetes.”
Laffel added that “these findings are particularly important given the need for more therapeutic options, especially oral agents, to manage type 2 diabetes in young people as, to date, metformin is the only globally available oral treatment for youth.”
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