Phase III Trial Demonstrated Jardiance® is the First SGLT2 Inhibitor to Show Statistically Significant Reduction in Blood Sugar Levels in Children and Adolescents with Type 2 Diabetes
- Jardiance® (empagliflozin) is the first SGLT2 inhibitor to demonstrate a statistically significant reduction in the primary outcome of HbA1c (a marker of average blood sugar) in participants aged 10-17 living with type 2 diabetes compared to placebo
- Safety data in this vulnerable population was similar to that in adults with type 2 diabetes, confirming the well-established safety profile of empagliflozin
INGELHEIM, DE & INDIANAPOLIS, US — The DINAMO Phase III clinical trial met its primary endpoint by demonstrating a statistically significant reduction in HbA1c (a marker of average blood sugar) with empagliflozin compared with placebo for children and adolescents aged 10-17 years living with type 2 diabetes.1 When empagliflozin was added to other baseline treatments (diet, exercise, metformin and/or insulin) HbA1c was reduced by 0.84% compared with placebo at week 26 (95% CI –1.50 to –0.19; P=0.012).1 The results were presented today at the International Diabetes Federation (IDF) World Diabetes congress 20221, Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) announced.1
The DINAMO (DIabetes study of liNAgliptin and eMpagliflozin in children and adOlescents) trial included youth aged 10-17 years with type 2 diabetes and HbA1c ≥6.5% and ≤10.5%. Participants were randomly assigned treatment with empagliflozin (10 or 25 mg) (n=52), linagliptin (5 mg) (n=53) or placebo (n=53) once daily. All participants were treated with diet and exercise plus, when appropriate, metformin and/or insulin.1
The overall safety data was generally consistent with previous findings in adults with type 2 diabetes, confirming the well-established safety profile of both Jardiance® (empagliflozin) and Trajenta® (linagliptin).1
“Across the lifespan, we know that people living with type 2 diabetes have a high risk for many diabetes complications, so it’s important to recognize and treat diabetes early in its course,” said Lori Laffel, M.D., Principal Investigator of the DINAMO study and Chief of the Pediatric, Adolescent, and Young Adult Section at the Joslin Diabetes Center and Professor of Pediatrics at Harvard Medical School. “Today’s 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. 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.”
A secondary endpoint from the trial showed that at week 26, empagliflozin reduced fasting plasma glucose (–35.2 mg/dL; P=0.0035).1
“With more than 41,000 new cases worldwide annually, type 2 diabetes in today’s young people is a global public health issue, especially in light of rise of risk factors such as obesity,” said Lykke Hinsch Gylvin, M.D., Chief Medical Officer at Boehringer Ingelheim. “The clinically meaningful benefit and consistent safety profile demonstrated with empagliflozin in the DINAMO trial is an encouraging outcome for the vulnerable population of children and adolescents.”
“The rise in the prevalence of type 2 diabetes in the pediatric population highlights a clear unmet need,” said Jeff Emmick, M.D., Ph.D., Vice President, Product Development, Eli Lilly & Company. “Having overcome the challenges in recruitment and design that pediatric trials tend to face, the outcomes of DINAMO represent another positive step forward in Boehringer Ingelheim and Lilly’s commitment to improve the lives of people living with cardio-renal and metabolic conditions such as type 2 diabetes.”
Reduction in HbA1c in participants treated with linagliptin was not statistically significant when compared with placebo. A numerical reduction of 0.34% (P=0.2935) was observed.1
The findings have been submitted for publication in a peer-reviewed journal.
Notes to editors
About DINAMO: DIabetes study of liNAgliptin and eMpagliflozin in children and adOlescents
DINAMO (NCT03429543) enrolled children and adolescents aged 10-17 years with type 2 diabetes (HbA1c ≥6.5% and ≤10.5%). Of the 262 participants screened, 158 were randomly assigned to treatment with empagliflozin (10 or 25 mg) (n=52), linagliptin (5 mg) (n=53) or placebo (n=53) once daily. All participants were treated with diet and exercise plus metformin and/or insulin (or no background if metformin intolerant). The trial compared efficacy and safety of an empagliflozin dosing regimen compared with placebo and linagliptin compared with placebo on durable glycemic control in youth with type 2 diabetes.2
Empagliflozin (marketed as Jardiance®) is an oral, once-daily, highly selective sodium-glucose cotransporter 2 (SGLT2) inhibitor and the first type 2 diabetes medicine to include cardiovascular death risk reduction data in its label in several countries.3,4
Boehringer Ingelheim and Eli Lilly and Company
In January 2011, Boehringer Ingelheim and Eli Lilly and Company announced an Alliance that centers on compounds representing several of the largest diabetes treatment classes. Depending on geographies, the companies either co-promote or separately promote the respective molecules each contributing to the Alliance. The Alliance leverages the strengths of two of the world’s leading pharmaceutical companies to focus on patient needs. By joining forces, the companies demonstrate their commitment, not only to the care of people with diabetes, but also to investigating the potential to address areas of unmet medical need.
About Boehringer Ingelheim
Boehringer Ingelheim is working on breakthrough therapies that improve the lives of humans and animals. As a leading research-driven biopharmaceutical company, the company creates value through innovation in areas of high unmet medical need. Founded in 1885 and family-owned ever since, Boehringer Ingelheim takes a long-term perspective. Around 52,000 employees serve more than 130 markets in the three business areas, Human Pharma, Animal Health, and Biopharmaceutical Contract Manufacturing. Learn more at [www.boehringer-ingelheim.com].
About Eli Lilly and Company
Lilly unites caring with discovery to create medicines that make life better for people around the world. We’ve been pioneering life-changing discoveries for nearly 150 years, and today our medicines help more than 47 million people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world’s most significant health challenges, redefining diabetes care, treating obesity and curtailing its most devastating long-term effects, advancing the fight against Alzheimer’s disease, providing solutions to some of the most debilitating immune system disorders, and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we’re motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. To learn more, visit Lilly.com and Lilly.com/newsroom or follow us on Facebook, Instagram and LinkedIn.
This press release is issued from Boehringer Ingelheim Corporate Headquarters in Ingelheim, Germany and is intended to provide information about our global business. Please be aware that information relating to the approval status and labels of approved products may vary from country to country, and a country-specific press release on this topic may have been issued in the countries where Boehringer Ingelheim and Eli Lilly and Company do business.
This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about Jardiance® as a treatment for adults with type 2 diabetes, to reduce the risk of cardiovascular death in adults with type 2 diabetes and known cardiovascular disease, and to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure, and as a potential treatment for adults with cardio-kidney-metabolic conditions and reflects Lilly’s current beliefs and expectations. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of drug research, development and commercialization. Among other things, there can be no guarantee that planned or ongoing studies will be completed as planned, that future study results will be consistent with the results to date or that Jardiance® will receive additional regulatory approvals. For a further discussion of these and other risks and uncertainties that could cause actual results to differ from Lilly’s expectations, please see Lilly’s most recent Forms 10-K and 10-Q filed with the U.S. Securities and Exchange Commission. Lilly undertakes no duty to update forward-looking statements.
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1 International Diabetes Federation (IDF) World Diabetes congress 2022. Laffel L. DINAMO study of adolescents. Lisbon, Portugal. 5-8 December 2022.
2 Laffel LM, Danne T, et al. DINAMO—Diabetes Study of Linagliptin and Empagliflozin in Children and Adolescents with Type 2 Diabetes (T2D): Innovative Study Design and Baseline Characteristics. Diabetes. June 2022. DOI:10.2337/db22-994-P.
3 Jardiance® (empagliflozin) tablets. European Product Information, approved April 2020. Available at: https://www.ema.europa.eu/en/documents/product-information/jardiance-epar-product-information_en.pdf [Last accessed: November 2022].
4 Jardiance® (empagliflozin) tablets, U.S. Prescribing Information. Available at: http://docs.boehringer-ingelheim.com/Prescribing%20Information/PIs/Jardiance/jardiance.pdf [Last accessed: November 2022].