Investor Presentation Full Year 2021
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Investor presentation Full year 2021
Novo NordiskⓇ
Semaglutide 2.0 mg s.c. and high dose oral sema hold potential to
bring patients needing treatment intensification to target
Phase 3 trial, SUSTAIN FORTE, completed and label application
submitted US¹ and approved in the EU
Phase 3 trial with oral semaglutide 25 mg and 50 mg in T2D has
been initiated
Estimand
Trial product estimand
Treatment policy estimand
Semaglutide 50 mg
Once-weekly
2.0 mg
1.0 mg
2.0 mg
1.0 mg
Semaglutide 25 mg
semaglutide
HbA1c
2.2%*
1.9%
2.1%*
1.9%
reduction
Semaglutide 14 mg
Body weight
6.9*
6.0
6.4
5.6
Dose escalation
reduction (kg)
HbA1c < 7.0%2
68%
58%
Efficacy
Objective
•
Semaglutide 2.0 mg s.c. showed superior HbA1c reduction with more patients
reaching target¹ versus semaglutide 1.0 mg s.c.
Safety
Semaglutide 2.0 mg appeared to have a safe and well-tolerated profile
Gastrointestinal adverse events were similar for semaglutide 2.0 mg
.
Nausea rates around 15%
•
Treatment discontinuation rates below 5%
Label expansion application submitted in US and approved in EU
1 Refusal to file received in March 2021. Resubmitted on 28 May 2021; 2 ADA recommended treatment target
*Statistically significant
S.c.: subcutaneous; Sema: Semaglutide; T2D: Type 2 diabetes
Maintenance
Primary endpoint
after 52 weeks
68 weeks on-treatment
5-weeks
Follow-up
Trial will assess efficacy for patients in need of improved outcomes
Primary endpoint
.
Confirm superiority of semaglutide 25 mg and 50 mg once-daily versus oral
semaglutide 14 mg on HbA1c reductionView entire presentation