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High-alert therapy area: The blurred boundary between diabetes treatment and weight management has created significant compliance risk for GLP-1 and SGLT-2 teams. Cardiorenal benefit claims, class effect statements and weight loss promotion — even as secondary messaging — are consistent PMCPA triggers across this category.
SGLT-2 inhibitor cardiorenal data spans multiple CVOTs and renal outcome trials, with different endpoints and patient populations. Conflating heart failure, renal protection and MACE data — or claiming outcomes across a population not represented in the trial — is a persistent high-risk area.
GLP-1 agonist promotional materials that highlight weight loss as a benefit — even as a secondary endpoint — risk straying into off-label obesity promotion. This is a particularly sensitive issue given the Ozempic/Wegovy overlap and PMCPA scrutiny since 2022.
Attributing cardiovascular or renal outcomes demonstrated in one SGLT-2 inhibitor trial to the class as a whole — or to an agent whose licence was extended later — has resulted in multiple upheld PMCPA complaints across the diabetes space.
Comparative claims between insulin biosimilars and reference products, or between biosimilar insulins, require careful attention to equivalence data, trial design and the distinction between bioequivalence and clinical equivalence.
Framing competitor insulins or diabetes medicines as carrying higher hypoglycaemia risk without robust comparative data, or using hypoglycaemia endpoint data selectively, is a source of competitor complaints in the diabetes space.
Indirect comparisons between DPP-4 inhibitors and GLP-1 agonists in HbA1c reduction, weight or cardiovascular outcomes without head-to-head data require very careful qualification to avoid upheld PMCPA rulings.
Built specifically for pharma teams working in diabetes — not generic compliance content repurposed for your therapy area.
The pack includes expert walkthroughs of all relevant PMCPA adjudications in the diabetes space. Here are three landmark cases.
The pack includes all relevant diabetes PMCPA cases with video walkthroughs, expert commentary and quiz questions.
MSLs and medical advisors presenting GLP-1 and SGLT-2 data across diabetology, cardiology and nephrology, where cardiorenal claims require precise indication awareness
Sales representatives and brand managers responsible for diabetes promotional materials, digital campaigns and primary care communications involving cardiorenal data
HEOR and market access teams making NHS, NICE and formulary claims for diabetes products — particularly for SGLT-2 inhibitors across multiple indications
Regulatory affairs and compliance officers reviewing diabetes promotional materials for class effect language, weight loss messaging and cardiorenal benefit claim scope
Speak to us about the Diabetes Compliance Pack. Tell us your team size and therapy area focus and we'll put together the right package.
Also available: GLP-1 & Obesity Compliance Pack →
Ozempic, Wegovy, Mounjaro, Zepbound. The highest-risk therapy area in 2024–25 for PMCPA complaints.
All 2,000+ PMCPA cases. Video. Podcast. Quiz. 5 points per case. The only case library of its kind in the UK.
12 therapy area packs covering Respiratory, Oncology, Cardiovascular, CNS, Diabetes, Immunology, Infectious Diseases, Dermatology, Musculoskeletal, Ophthalmology and more.
One real case. One key lesson. Every week — free.