Latest news with #sitagliptin
Medscape
04-08-2025
- Health
- Medscape
Add-On Lobeglitazone Boosts Glycemic Control in T2D
TOPLINE: Patients with type 2 diabetes (T2D) who responded inadequately to sitagliptin plus metformin experienced improvements in glycemic control and insulin sensitivity after lobeglitazone was added to their regimen. METHODOLOGY: Metformin and DPP-4 inhibitors such as sitagliptin are widely used for glycemic control in patients with T2D; however, the choice of which agent to add when these therapies fail to achieve target blood glucose levels remains unclear. Researchers in Korea conducted a phase 3 trial from April 2018 to December 2021 to evaluate the efficacy and safety of adding lobeglitazone to the dual therapy regimen of metformin (≥ 1000 mg/d) and sitagliptin (100 mg/d). The study included 231 patients with T2D (mean age, 58.65 years; 56.52% men) whose A1c ranged from 7.0% to 10.0% despite receiving the dual therapy. After a 2-week run-in period, patients were randomly assigned to receive either a 0.5 mg/d dose of lobeglitazone (n = 116) or placebo (n = 115) alongside metformin and sitagliptin for 24 weeks, followed by a 28-week open-label phase in which all patients received lobeglitazone. The primary endpoint was the change from baseline in mean A1c at 24 weeks. Secondary endpoints included changes in additional glycemic and lipid parameters and safety outcomes. TAKEAWAY: At week 24, mean A1c levels were 1.03% lower in patients who received lobeglitazone vs placebo (95% CI, -1.23% to -0.82%), with the reduction being maintained until 52 weeks; those who switched from placebo to lobeglitazone at week 24 also saw a reduction in A1c levels by week 52. Additionally, at week 24, a higher proportion of patients receiving lobeglitazone vs placebo achieved A1c levels < 6.5% (27.14% vs 0.87%) and < 7% (53.04% vs 13.04%; both P < .0001). The addition of lobeglitazone to dual therapy significantly improved insulin sensitivity markers compared with placebo at week 24, with effects sustained till week 52; additionally, administration of lobeglitazone reduced low-density lipoprotein cholesterol levels. The incidence of adverse events was not significantly different between the two groups; the incidence of edema and weight gain in some patients receiving lobeglitazone aligned with the known effects of thiazolidinediones. IN PRACTICE: 'The observed improvements in various glucose-related metabolic factors and lipid metabolism indicators with lobeglitazone coadministration may provide valuable evidence for long-term blood glucose management and cardiovascular risk reduction,' the authors of the study wrote. SOURCE: This study was led by Eun-Gyoung Hong, MD, Hallym University Dongtan Sacred Heart Hospital, Hwaseong, South Korea. It was published online in Diabetes, Obesity and Metabolism. LIMITATIONS: A longer follow-up might be needed to fully evaluate the sustained effects of the study outcomes and potential side effects. DISCLOSURES: This study received funding from Chong Kun Dang Pharmaceutical Company. The authors declared having no conflicts of interest. This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
Yahoo
31-07-2025
- Health
- Yahoo
Azurity Pharmaceuticals, Inc. Announces the Availability of BRYNOVIN™ (sitagliptin), the First and Only Oral Liquid Sitagliptin
WOBURN, Mass., July 31, 2025 /PRNewswire/ -- Azurity Pharmaceuticals, Inc. announced today the availability of BRYNOVIN™ (sitagliptin) oral solution, a dipeptidyl peptidase-4 (DPP-4) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. BRYNOVIN is not recommended in patients with type 1 diabetes and has not been studied in patients with a history of pancreatitis. BRYNOVIN, which was approved by the U.S. Food and Drug Administration (FDA) in January 2025, is the first and only oral liquid sitagliptin for the management of type 2 diabetes mellitus in adults in conjunction with diet and exercise.1 "BRYNOVIN demonstrates our commitment to breaking down barriers to patient care by providing sitagliptin in an oral liquid solution for adult patients with T2DM that may have difficulty swallowing pills or may have needle fear that affects treatment adherence," said Ron Scarboro, CEO at Azurity Pharmaceuticals. "Building on our longstanding legacy in dose form innovations, we continue to rapidly grow our capabilities in this space and deliver on our purpose to serve overlooked patients." With more than 38 million Americans living with diabetes2, and 90-95% of them diagnosed with type 2 diabetes, there remains a significant need for alternative treatment options3. For many, especially older adults and those in long-term care facilities, swallowing pills is a daily challenge that may lead to poor adherence and compromised outcomes4,5. BRYNOVIN provides effective HbA1c control as an adjunct to diet and exercise when used as monotherapy or in combination with other antihyperglycemic agents in adults with type 2 diabetes mellitus. The recommended dose of BRYNOVIN is 100 mg (25 mg/mL), administered as 4 mL once daily. BRYNOVIN is not recommended in patients with type 1 diabetes and has not been studied in patients with a history of pancreatitis. For full prescribing information, please visit 1. U.S Food and Drug Administration Orange Book. Accessed July 21, 2025. Centers for Disease Control and Prevention (CDC). Type 2 Diabetes. Accessed July 17, 2025 Centers for Disease Control and Prevention (CDC). National Diabetes Statistics Report 2024. https:// Wittenberg E, et al. "Medication Adherence in Older Adults: A Qualitative Study." Patient Preference and Adherence. 2019;13:1443–1450.5. Schiele J et al "Difficulties swallowing solid oral dosage forms in a general practice population: prevalence, causes, and relationship to dosage forms" Eur J Clinical Pharmacol (2013) 69:937-948 About Azurity Pharmaceuticals:Azurity Pharmaceuticals is a privately held company committed to delivering innovative, high-quality medicines for overlooked patients. Azurity's global footprint is over 50 countries, with a diversified portfolio of 50+ medicines spanning 10 dosage forms and 10 key therapeutic areas. Powered by its Next-Gen Commercial Model, Azurity leverages data, analytics, and AI-driven digital tools to enhance market reach and stakeholder engagement. Our medicines have benefited millions of people. For more information, including prescribing information, visit ©2025 Azurity Pharmaceuticals, Inc. PP-BRN-US-0029 View original content to download multimedia: SOURCE Azurity Pharmaceuticals
