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Courier | significantly lower blood sugar level, diabetes therapy phase 3 of the primary end point

Eli Lilly and Boehringer Ingelheim recently presented the results of Phase 3 clinical trials at the International Diabetes Federation (IDF) World Diabetes Congress 2022. Its partner drug, Jardiance, is the first SGLT2 inhibitor to be shown to produce a statistically significant reduction in the mean blood glucose marker HbA1c compared with placebo in patients aged 10-17 with type 2 diabetes, the press release noted.
The incidence of type 2 diabetes in children and adolescents has been on the rise since the mid-1990s. This chronic condition can lead to serious long-term problems if not properly treated and patients are at higher risk of diabetes complications. Therefore, it is particularly important to identify and treat diabetes early in its course.
Jardiance (empagliflozin) is an SGLT2 inhibitor that has been approved by the US FDA. Such drugs prevent salt reabsorption, thereby increasing salt excretion in the body and reducing fluid load on the body's vascular system. It induces changes in the metabolism of sugar, salt and water in the body that may help reduce cardiovascular death.
Jardiance is currently approved to reduce the risk of cardiovascular death and hospitalization in adults with heart failure because the heart cannot pump enough blood around the body. Jardiance is also approved to reduce the risk of cardiovascular death in adults with type 2 diabetes and cardiovascular disease, and to reduce blood glucose levels in adults with type 2 diabetes combined with diet and exercise therapy.
The clinical trial of DINAMO was published to examine the efficacy and safety of Jardiance versus the diabetes drug Tradjenta (linagliptin) in children and adolescents aged 10-17 years with type 2 diabetes. The HbA1c of enrolled patients was ≥6.5% and ≤10.5%. Subjects were treated with Jardiance (10 or 25 mg) once daily (n=52), Tradjenta (n=53), or placebo (n=53). All subjects received diet and exercise, plus metformin and/or insulin when appropriate.
The results showed that the study met its primary endpoint. Children and adolescents ages 10-17 with type 2 diabetes showed a statistically significant reduction in HbA1c with Jardiance compared to placebo, and when Jardiance was added to other baseline treatments (diet, exercise, metformin and/or insulin), HbA1c at week 26 was 0.84 percentage points lower than placebo (95% CI: -- 1.50 to -- 0.19; P=0.012). However, the reduction in HbA1c in patients receiving active control therapy was only 0.34 percentage points compared with placebo, which was not statistically significant (P=0.2935). The overall safety data are generally consistent with previous findings in adults with type 2 diabetes, confirming the safety of Jardiance and Tradjenta.

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DINAMO study principal investigator Dr. Lori Laffel, chief of the Division of Pediatrics, Adolescents and Young Adults at the Joslin Diabetes Center and professor of pediatrics at Harvard Medical School, said: "The results of the DINAMO global clinical trial demonstrate that the SGLT2 inhibitor Jardiance significantly improved overall glycemic control in children and adolescents with type 2 diabetes compared to placebo. To date, metformin remains the only oral drug available worldwide to treat young patients with type 2 diabetes. So these findings are particularly important in providing more treatment options for these patients."
Dr. Lykke Hinsch Gylvin, Boehringer Ingelheim's chief Medical officer, said, "Today, with more than 41,000 new cases of type 2 diabetes in young people worldwide each year, this has become a global public health concern, especially given the rise in risk factors such as obesity. The clinically meaningful benefit and consistent safety profile of Jardiance demonstrated in the DINAMO trial is an encouraging result for a vulnerable population of children and adolescents."
"The rising prevalence of type 2 diabetes in the childhood population highlights a clear unmet need," said Dr. Jeff Emmick, Vice President of product development at Eli Lilly. In overcoming the recruitment and design challenges that pediatric trials often face, DINAMO's results represent another positive step in Boehringer Ingelheim's and Lilly's commitment to improving the lives of patients with heart, kidney and metabolic diseases such as type 2 diabetes.
Reference Materials: [1] Phase III trial demonstrated Jardiance® is the first SGLT2 inhibitor to show statistically significant reduction in activity blood sugar levels in children and adolescents with type 2 diabetes. Retrieved December 7, 2022,  from tor
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