Sanofi v Novo Nordisk: Tresiba leavepiece claims (75% less variability; 142 fewer nocturnal hypoglycaemic events) ruled misleading

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Key facts

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Case	AUTH/2938/2/17
Complainant	Sanofi UK
Respondent	Novo Nordisk Ltd
Material	Tresiba leavepiece (ref UK/TB/1214/0302(4))
Product	Tresiba (insulin degludec)
Main issues	Clamp-study variability claim presented as clinically definitive; “benefits” bullets not substantiated; large-font “142 fewer” claim insufficiently qualified and exaggerated overall impression
Breach clauses	7.2, 7.3, 7.4, 7.8
Applicable Code year	2016
Complaint received	20 February 2017
Case completed	7 July 2017
Appeal	No appeal
Sanctions	Undertaking received; Additional sanctions: Not stated

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

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Sanofi UK complained about a Novo Nordisk promotional leavepiece for Tresiba (insulin degludec) (ref UK/TB/1214/0302(4)).
Page 3 headline claim: “Tresiba provides 75% less variability in glucose-lowering effect over 24 hours versus insulin glargine U100”, with a prominent “75% Less Variability” call-out and a bar chart referenced to Heise et al (2012) (a euglycaemic clamp study).
The page also presented “Benefits of lower variability” with bullets: “A potentially lower risk of hypo- and hyperglycaemia” and “Potentially aids titration to glycaemia targets”.
Sanofi argued the material did not clearly and prominently state the variability data were from an experimental clamp study and that the design implied real-world clinical benefit.
Page 4 included a large-font claim “142 Fewer Nocturnal Hypoglycaemic Events” with smaller qualifying text “for every 100 patients treated with Tresiba per year versus insulin glargine U100”, plus a statement (in smaller text) that there was no significant difference in overall confirmed hypoglycaemia (p=ns).
The Panel considered the gate-fold design meant page 3 sat within a “clinical story” alongside page 4, increasing the risk that clamp data would be read as clinically definitive.

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Breach found: Page 3 variability presentation was misleading because it did not make sufficiently clear the data were from a clamp study and required caution when applying to clinical practice (Clauses 7.2 and 7.3).
Breach found: The prominence/visual presentation of the variability claim and chart did not give a fair, balanced view or enable the nature of the data to be readily understood (Clause 7.8).
Breach found: “Benefits of lower variability” bullets were misleading and not substantiated as presented (Clauses 7.2 and 7.4).
Breach found: “142 Fewer Nocturnal Hypoglycaemic Events” exaggerated the difference; the qualification and “no significant difference overall” statement were not sufficiently prominent to correct the overall impression (Clause 7.2).
Sanctions: Undertaking received. No appeal. (Applicable Code year: 2016.)

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