IN-BOEHRINGER-INGELHEIM
7.12.2022 10:40:38 CET | Business Wire | Press release
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
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20221207005405/en/
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.
Please click on the below link for further ‘Notes to editors’ and ‘References’:
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20221207005405/en/
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Hisense Delivers 38% Sales Uplift in Western Europe Markets With NIQ’s AI-Powered Market Intelligence6.5.2026 05:00:00 CEST | Press release
NIQ insights drive international expansion and measurable growth for Hisense across key global markets NIQ (NYSE: NIQ), a global leader in consumer intelligence, today shared new learnings from its long-standing collaboration with Hisense, a leading global brand in home appliances and smart technologies. Using NIQ’s AI‑powered market intelligence, Hisense has accelerated international expansion, improved local market decision-making, and delivered measurable growth across more than 20 key markets and 12+ categories. The case study demonstrates how AI‑driven insights help global brands move faster, localize better, and compete more effectively in complex markets. The Challenge As Hisense expanded internationally, it faced rising complexity across global markets. Consumer preferences differed sharply across regions such as Western Europe, Eastern Europe, and Latin America, making a one‑size‑fits‑all approach ineffective. NIQ’s AI‑powered intelligence delivered the local market depth need
Samsung Bioepis Announces Positive Preliminary Phase 1 Data for SB27, Proposed Biosimilar to Keytruda (Pembrolizumab)6.5.2026 01:00:00 CEST | Press release
Phase 1 study has demonstrated pharmacokinetics (PK) equivalence between SB27 and KeytrudaPhase 1 and Phase 3 studies expected to be completed within 2026 Samsung Bioepis Co., Ltd. announced today that the Phase 1 study on SB27, a proposed biosimilar to Keytruda1 (pembrolizumab), has met its primary pharmacokinetics (PK) endpoints. The randomized, double-blind, three-arm, parallel group, multicenter clinical trial demonstrated pharmacokinetic bioequivalence of SB27 (pembrolizumab) to the reference product Keytruda. Initiated in January 2024, Phase 1 study is being conducted in four countries, and is expected to be completed by November 2026.2 The study assessed pharmacokinetics, efficacy, safety, and immunogenicity of SB27, EU-sourced Keytruda, and US-sourced Keytruda in patients with stage II or IIIA non-small cell lung cancer (NSCLC) following complete resection and adjuvant platinum-based chemotherapy. 163 participants were randomized to receive SB27, EU-sourced Keytruda, or US-sour
Megaport Launches Built-In DDoS Protection Enabling On-Demand Network Resilience6.5.2026 00:00:00 CEST | Press release
Megaport DDoS Protection removes the trade-off between security, performance, and cost, offering rapid enterprise-grade mitigation. Megaport Limited (ASX: MP1) (“Megaport”), a leading global automated infrastructure platform, today announced the launch of Megaport DDoS Protection. This new, built-in security capability for Megaport Internet allows customers to filter malicious traffic directly within the Megaport network rather than routing it through a separate or external service, for mission-critical uptime without introducing additional latency or routing complexity. As enterprises increasingly migrate to distributed cloud environments, traditional DDoS mitigation has struggled to keep pace with cloud and distributed infrastructure adoption. Standard ISP solutions often resort to dropping all traffic and taking the service offline to protect the network, while external third-party providers force a "security detour" that reroutes traffic through public infrastructure, introducing s
IFF Reports First Quarter 2026 Results5.5.2026 22:23:00 CEST | Press release
Delivered solid top and bottom line Q1 resultsProgressing disciplined sale process for Food Ingredients businessReaffirms Full Year 2026 Financial Guidance IFF (NYSE: IFF) reported financial results for the first quarter ended March 31, 2026. First Quarter 2026 Consolidated Summary: Management Commentary “IFF is off to a solid start in 2026, with first quarter results that reflect the customer focus and operational execution we’ve been building across the company,” said Erik Fyrwald, CEO of IFF. “We delivered volume growth in all four segments, improved profitability, and generated strong cash flow in the first quarter. As we look ahead, we are maintaining a disciplined approach to how we are planning the balance of the year as the current operating environment remains unsettled. We remained focused on advancing our commercial and innovation pipelines, driving productivity, and working with customers to offset inflation. This – when combined with our solid start to the year – derisks t
Logitech Announces Q4 and Full Fiscal Year 2026 Results5.5.2026 22:06:00 CEST | Press release
Strong FY 2026 Demonstrates Strategy and Operating Principles Are Delivering SIX Swiss Exchange Ad hoc announcement pursuant to Art. 53 LR — Logitech International (SIX: LOGN) (Nasdaq: LOGI) today announced financial results for the fourth quarter and full Fiscal Year 2026. For Fiscal Year 2026: Sales were $4.84 billion, up 6 percent in US dollars and 4 percent in constant currency compared to the prior year. GAAP operating income was $775 million, up 18 percent compared to the prior year. Non-GAAP operating income was $911 million, up 18 percent compared to the prior year. GAAP earnings per share was $4.80, up 16 percent compared to the prior year. Non-GAAP EPS was $5.78, up 19 percent compared to the prior year. Cash flow from operations was $1.04 billion. The year-ending cash balance was $1.7 billion. The Company returned $768 million of cash to shareholders through its annual dividend payment and share repurchases. For Q4 Fiscal Year 2026: Sales were $1.09 billion, up 7 percent in
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom