Type 2 Diabetes in 2025: Year in Review

2025 was a banner year for type 2 diabetes (T2D) – between the approval and release of new glucose monitors, like the Dexcom G7 15-day and the Biolinq Shine, and the meteoric rise of orforglipron through the investigative period for T2D. The US Food and Drug Administration (FDA) also played a major role this year, with highlights including the first oral GLP-1 receptor agonist for cardiovascular risk reduction in T2D and the end of the years-long semaglutide and tirzepatide shortage.

With so many critical updates in an already busy year, the editorial team at HCPLive has collected the top 13 stories of 2025, including key FDA approvals, crucial trial results, and expert clinician perspectives. Catch up on some of the biggest news you missed in 2025 below:

FDA News

FDA Approves Semaglutide (Ozempic) for Type 2 Diabetes, Chronic Kidney Disease

On January 28, 2025, the FDA approved semaglutide for cardiovascular disease-related mortality and worsening kidney disease in patients with T2D and chronic kidney disease (CKD). This decision addressed a significant treatment gap in T2D, especially given the connection between T2D and major kidney and cardiovascular outcomes. The FDA’s decision was based on the phase 3b FLOW trial, which saw semaglutide demonstrate superior risk reduction of kidney disease worsening and cardiovascular disease death when added to standard care versus placebo.

FDA Announces End to Shortage of Semaglutide Products (Ozempic, Wegovy)

On February 21, 2025, Novo Nordisk announced an end to the shortage of semaglutide products, which had begun in March of 2022. The FDA and Novo Nordisk confirmed that manufacturing capabilities could now meet projected national demand, although supply disruptions continued for a brief period after the announcement. This declaration also put an end to the issue of compounded medications, which circulated from 2022 until 2025 and posed a serious risk to patients, given their lower quality and potential to cause direct harm.

FDA Clears Dexcom G7 15 Day CGM System

Dexcom announced on April 10, 2025, that the new G7 continuous glucose monitoring (CGM) system received clearance from the FDA. Besides the longest-lasting CGM system on the market at 15.5 days of wear and a mean absolute relative difference of 8%, the G7 also boasts a waterproof sensor, direct connectivity to smartwatches, and automated activity logging with a 12-hour grace period for an uninterrupted transition for sensor replacement. Dexcom has more recently announced a planned pharmaceutical launch in early January 2026.

FDA Grants De Novo Classification to Needle-Free Glucose Monitor

With this De Novo Classification, the Biolinq Shine stands to become the first wearable glucose biosensor to not require a needle for sensor placement. The monitor will integrate glucose, activity, and sleep information into a single, autonomous device in the form of a patch placed on the forearm. The Biolinq Shine will provide real-time glucose feedback through a primary color-coded LED display. It circumvents the need for a subcutaneous introducer needle by utilizing a microsensor array, which is up to 20 times shallower than conventional continuous glucose sensors.

FDA Approves Oral Semaglutide (Rybelsus) for CV Risk Reduction in Type 2 Diabetes

On October 17, 2025, the FDA announced their approval of oral semaglutide, which is now the first oral GLP-1 approved for major adverse cardiovascular events in adult patients with T2D. This decision further blurs the line between endocrinology and cardiology, with this semaglutide dose demonstrating a substantial 14% relative risk reduction in major adverse cardiovascular events after 4 years of follow-up in the phase 3b SOUL trial.

Trial Updates and New Guidelines

SOUL: Oral Semaglutide Cuts MACE by 14% in People with Type 2 Diabetes

4-year results from the SOUL trial provided the backbone for the FDA’s approval of oral semaglutide for cardiovascular disease risk – the tablet dose led to a 14% reduction of cardiovascular death, heart attack, and stroke in patients with T2D. This double-blind, placebo-controlled, event-driven, superiority trial marked the first significant exploration of oral semaglutide’s impact on cardiovascular outcomes, and its positive topline results helped to boost GLP-1s to their current cardioprotective standing.

Obicetrapib Reduces HbA1c, New-Onset Diabetes Risk in ASCVD, HeFH

A pooled analysis of the phase 3 BROOKLYN and BROADWAY trials highlighted obicetrapib’s capacity for reducing HbA1c and lowering new-onset diabetes risk in patients with atherosclerotic cardiovascular disease or heterozygous familial hypercholesterolemia and prediabetes or normoglycemia. Meta-analysis results from this pooled analysis showed similarities between obicetrapib and other CETP inhibitors, opening an important new pathway for preventative medicine research in prediabetes.

CATALYST Trial: Mifepristone Improves Glycemic Control in Type 2 Diabetes with Hypercortisolism

Part 2 of the phase 4 CATALYST trial highlighted mifepristone’s efficacy in improving glycemic control, reducing body weight, and decreasing waist circumference in patients with T2D and hypercortisolism, leading to 49% of patients on mifepristone discontinuing therapy compared to 18% in placebo. Although investigators also noted an increase in blood pressure as a result of mifepristone treatment, the data still offer a promising new opportunity for a historically underserved population.

Orforglipron Delivers Weight Loss, A1C Reductions in Phase 3 ATTAIN-2 Trial

Orforglipron was thrust into the spotlight after the ATTAIN-2 trial highlighted substantial improvements in cardiometabolic risk factors, weight loss, and A1C reduction in patients with obesity or overweight and T2D. The trial met its primary and all key secondary endpoints, positioning the once-daily small molecule oral GLP-1 as a revolutionary method of circumventing the frequent issues and stresses patients face in a field of only injectable agents.

ACHIEVE-3: Orforglipron Superior to Semaglutide for Type 2 Diabetes in Phase 3 Trial

Continuing its rapid advancements, orforglipron also outperformed semaglutide in treating T2D inadequately controlled with metformin. Results from the phase 3 ACHIEVE-3 trial showed an average A1C reduction of 1.9% and 2.2% for the 12 and 36 mg doses of orforglipron, compared to 1.1% and 1.4% in the 7 and 14 mg doses of semaglutide. Additionally, orforglipron recipients saw an average loss of 14.6 and 19.7 lbs, compared to 7.9 and 11 lbs in semaglutide. Between ACHIEVE and ATTAIN, orforglipron is positioned for an excellent performance in 2026.

Feature Content/Podcasts

Diabetes Dialogue: ADA’s 2025 Standards of Care in Diabetes Therapeutics

In this January 2025 episode of Diabetes Dialogue, cohosts Diana Isaacs, PharmD, and Natalie Bellini, DNP, discussed the updated American Diabetes Association (ADA) 2025 Standards of Care. These updates included substantial changes to treatment algorithms, aiming to expand flexibility for treating T2D and CKD. The ADA highlighted treatments such as GLP-1s and sodium-glucose co-transporter 2 (SGLT2) inhibitors, particularly in combination.

Diabetes Dialogue: CATALYST Trial, Mifepristone, and Hypercortisolism in T2D, with John Buse, MD, PhD

This June 23, 2025 episode saw Isaacs and Bellini speak with John Buse, MD, PhD, of the University of North Carolina School of Medicine, about the phase 4 CATALYST trial. During the trial, mifepristone (Korlym) had shown significant improvements in glycemic control and reductions in body weight and waist circumference in patients with hypercortisolism and difficult-to-control T2D. Given this population’s history of limited treatment success, mifepristone is a promising new alternative to existing medications.

Diabetes Dialogue: Reacting to Retatrutide and TRIUMPH-4 Topline Data

On December 16, 2025, Isaacs and Bellini covered the groundbreaking TRIUMPH-4 trial data, which showcased retatrutide’s impact on weight and pain for patients with obesity and osteoarthritis. The once-weekly triple GIP/GLP-1/glucagon receptor agonist caused a mean weight loss of 28.7% at 68 weeks, plus a reduction of 75.8% in WOMAC pain scores from baseline by week 68. Although full trial details are still forthcoming, these findings reflect positively on the ADA’s recent push towards obesity-related comorbidities like osteoarthritis, sleep apnea, and kidney disease.