An Open-label, One-sequence Cross Over, Single Centre Trial, Investigating the Influence of Semaglutide on Pharmacokinetics and Pharmacodynamics of Warfarin and Pharmacokinetics of Metformin in Healthy Subjects

Registration

Registration

NCT02022254

Study type

INTERVENTIONAL

Phase

PHASE1

Masking

NONE

Status

COMPLETED

Enrollment

24

Start

2013-12-17

Primary completion

2014-08-28

Lead sponsor

Novo Nordisk A/S

Conditions

Diabetes; Diabetes Mellitus, Type 2; Healthy

Interventions

DRUG:semaglutide; DRUG:placebo; DRUG:metformin; DRUG:warfarin

Results posted

FALSE

Secondary identifiers

EUDRACT_NUMBER:2012-005072-33; OTHER:U1111-1136-6442

Registered primary outcomes

• Area under the metformin plasma concentration-time curve [During a dosing interval (0-12 hours) after the last of 7 repeated doses of metformin without semaglutide exposure (Day 4) and at semaglutide steady state (Day 104)]
• Area under the S-warfarin plasma concentration-time curve [From time 0 to 168 hours after a single dose of warfarin without semaglutide exposure (Day 11) and at semaglutide steady state (Day 111)]
• Area under the R-warfarin plasma concentration-time curve [From time 0 to 168 hours after a single dose of warfarin without semaglutide exposure (Day 11) and at semaglutide steady state (Day 111)]