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A study comparing exposure of semaglutide and dapagliflozin dosed orally as mono-components versus in a fixed-dose combination

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2022-500007-52-00
Acronym
NN9917-4751
Enrollment
138
Registered
2022-06-02
Start date
2022-06-14
Completion date
2023-04-13
Last updated
2023-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2

Brief summary

AUC(0-24h,sema,ss): area under the semaglutide plasma concentration−time curve during a dosing interval (0 to 24 hours) at steady state, AUC(0-24h,dapa,ss): area under the dapagliflozin plasma concentration−time curve during a dosing interval (0 to 24 hours) at steady state

Detailed description

Cmax,(sema,ss): maximum observed semaglutide plasma concentration during a dosing interval (0 to 24 hours) at steady state, Cmax,(dapa,ss): maximum observed dapagliflozin plasma concentration during a dosing interval (0 to 24 hours) at steady state, tmax,(sema,ss): time to maximum observed semaglutide plasma concentration during a dosing interval (0 to 24) at steady state, tmax,(dapa,ss): time to maximum observed dapagliflozin plasma concentration during a dosing interval (0 to 24 hours) at steady state

Interventions

DRUGSemaglutide D 9 mg
DRUGForxiga 10 mg film-coated tablets
DRUGSemaglutide D 4 mg
DRUGSemaglutide/dapagliflozin A 9/10 mg
DRUGSemaglutide D 1.5 mg
DRUGSemaglutide/dapagliflozin A 4/10 mg
DRUGSemaglutide/dapagliflozin A 1.5/10 mg

Sponsors

Novo Nordisk A/S
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
AUC(0-24h,sema,ss): area under the semaglutide plasma concentration−time curve during a dosing interval (0 to 24 hours) at steady state, AUC(0-24h,dapa,ss): area under the dapagliflozin plasma concentration−time curve during a dosing interval (0 to 24 hours) at steady state—

Secondary

MeasureTime frame
Cmax,(sema,ss): maximum observed semaglutide plasma concentration during a dosing interval (0 to 24 hours) at steady state, Cmax,(dapa,ss): maximum observed dapagliflozin plasma concentration during a dosing interval (0 to 24 hours) at steady state, tmax,(sema,ss): time to maximum observed semaglutide plasma concentration during a dosing interval (0 to 24) at steady state, tmax,(dapa,ss): time to maximum observed dapagliflozin plasma concentration during a dosing interval (0 to 24 hours) at steady state—

Countries

Germany

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026