Investor Presentation - First Six Months of 2021
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Investor presentation First six months of 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
Phase 3 trial with oral semaglutide 25 mg and 50 mg in T2D has
been initiated
submitted in the EU and the US1
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
•
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 applications submitted in both the EU and the US
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
•
Objective
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