Sanofi Toujeo leavepiece: BRIGHT study titration-phase hypoglycaemia data given disproportionate emphasis

📊

Key facts

⌄

Case	AUTH/3062/8/18
Complainant	Consultant physician (health professional)
Company	Sanofi
Material	Six-page A5 gate-folded leavepiece (SAGB.TJO.18.06.0924(1))
Medicine	Toujeo (insulin glargine 300 units/mL)
Indication (as stated)	Treatment of diabetes mellitus in adults
Study referenced	BRIGHT (Rosenstock et al, 2018), 24-week head-to-head study vs insulin degludec 100 units/mL
Main issue	Disproportionate emphasis on favourable 0–12 week titration-period hypoglycaemia results; insufficient prominence for comparable 24-week outcomes; misleading overall impression
Applicable Code year	2016
Breach clauses	7.2, 7.3
Complaint received	22 August 2018
Case completed	17 October 2018
Appeal	No appeal
Sanctions	Undertaking received; Additional sanctions: Not stated
Source	https://www.pmcpa.org.uk/cases/completed-cases/auth3062818-health-professional-v-sanofi

Reviewed by Dr Anzal Qurbain (FFPM) — ABPI Final Signatory

🤖

Got a question about this case?

Ask one of our 13 specialist ABPI advisors — instant answers, 24/7.

Ask AskAnzal AI

🎬 Expert Video Walkthrough

🎬

Video walkthrough — coming for members

Subscribe now and get expert video analysis for every case as we publish them.

Subscribe — from £299/yr

📋

⌄

A consultant physician complained about a six-page A5 gate-folded promotional leavepiece for Toujeo (insulin glargine 300 units/mL) (SAGB.TJO.18.06.0924(1)).
The leavepiece discussed the BRIGHT head-to-head 24-week study (Toujeo vs insulin degludec 100 units/mL) in insulin-naïve patients with type 2 diabetes.
The complainant alleged the leavepiece visually and prominently highlighted hypoglycaemia results from the 0–12 week titration period that favoured Toujeo, while the overall 24-week findings (showing comparable hypoglycaemia outcomes) were given much less prominence.
The complainant also argued the 0–12 week hypoglycaemia analysis was not a primary/secondary endpoint (it was presented as a safety endpoint) and queried whether it was pre-specified.
Sanofi denied breaches, arguing titration-phase hypoglycaemia was clinically relevant, pre-specified as a safety endpoint, and that comparable 24-week/maintenance results were stated in the leavepiece.
The Panel assessed the “immediate impression” on a busy health professional and the balance between titration-period graphics and full-period context.

⚖️

⌄

The Panel ruled the leavepiece misrepresented the BRIGHT study by placing disproportionate emphasis on favourable titration-period hypoglycaemia results without sufficient balance.
The Panel considered the immediate impression was a misleading comparison of Toujeo and insulin degludec.
Breaches were ruled for Clauses 7.2 and 7.3.
No appeal.

🔒

Members get the complete breakdown — Clauses, Sanction, Signatory Lens, Audit checklist, and 3 Key Questions.

Best value

£249/year

Annual — save £99

£29/mo

Monthly

Join Now — Instant Access