Back to resultsInfluence of Semaglutide on Pharmacokinetics and Pharmacodynamics of Warfarin and Pharmacokinetics of Metformin in Healthy Subjects
Primary Purpose
Diabetes, Diabetes Mellitus, Type 2, Healthy
Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
semaglutide
placebo
metformin
warfarin
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes
Eligibility Criteria
Inclusion Criteria:
- Male and female, age between 18 and 55 years (both inclusive) at the time of signing informed consent
- Body mass index (BMI) between 23 and 30 kg/m^2 (both inclusive)
Exclusion Criteria:
- Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearingpotential and not using adequate contraceptive methods for the duration of the trial and for 5 weeks following the last dose of semaglutide. Adequate contraceptive measures are implants, injectables, combined oral contraceptives, hormonal intrauterine device, sexual abstinence or vasectomised partner
- Any clinically significant disease history, in the opinion of the investigator, or systemic or organ disease including: pulmonary, gastrointestinal, hepatic, neurologic, renal, genitourinary and endocrine, dermatologic or hematologic diseases
- Use of prescription or non-prescription systemic or topical medicinal products (including routine or non-routine vitamins or herbal products, but excluding paracetamol and contraceptives) within 3 weeks (or within 5 half-lives of the medicinal product, whichever is longest) prior to Visit 2
- Smoking, drug or alcohol abuse
Sites / Locations
- Novo Nordisk Investigational Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Semaglutide administrations
Arm Description
Outcomes
Primary Outcome Measures
Area under the metformin plasma concentration-time curve
Area under the S-warfarin plasma concentration-time curve
Area under the R-warfarin plasma concentration-time curve
Secondary Outcome Measures
Maximum observed metformin plasma concentration at steady state
Maximum observed S-warfarin plasma concentration after single dose
Maximum observed R-warfarin plasma concentration after single dose
Incremental area under the INR (international normalised ratio) -curve
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02022254
Brief Title
Influence of Semaglutide on Pharmacokinetics and Pharmacodynamics of Warfarin and Pharmacokinetics of Metformin in Healthy Subjects
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
December 17, 2013 (Actual)
Primary Completion Date
August 28, 2014 (Actual)
Study Completion Date
August 28, 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This trial is conducted in Europe and Asia. The aim of the trial is to investigate the influence of semaglutide on pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of warfarin and pharmacokinetics of metformin in healthy subjects.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Diabetes Mellitus, Type 2, Healthy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Semaglutide administrations
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
semaglutide
Intervention Description
Subjects will initiate treatment with 0.25 mg for the first four weeks followed by dose doubling every four weeks up to a dose of 1.0 mg.
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Semaglutide placebo will be administered s.c.
Intervention Type
Drug
Intervention Name(s)
metformin
Intervention Description
For oral administration twice daily, in two periods, each of 3.5 days duration. The first period is initiated before semaglutide treatment and the second period is initiated at the end of semaglutide treatment.
Intervention Type
Drug
Intervention Name(s)
warfarin
Intervention Description
For oral administration, given as a single dose. The first dose is given before semaglutide treatment and the second dose is given at the end of semaglutide treatment.
Primary Outcome Measure Information:
Title
Area under the metformin plasma concentration-time curve
Time Frame
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)
Title
Area under the S-warfarin plasma concentration-time curve
Time Frame
From time 0 to 168 hours after a single dose of warfarin without semaglutide exposure (Day 11) and at semaglutide steady state (Day 111)
Title
Area under the R-warfarin plasma concentration-time curve
Time Frame
From time 0 to 168 hours after a single dose of warfarin without semaglutide exposure (Day 11) and at semaglutide steady state (Day 111)
Secondary Outcome Measure Information:
Title
Maximum observed metformin plasma concentration at steady state
Time Frame
From dosing until 30 hours after the last of 7 repeated doses without semaglutide exposure and at semaglutide steady state (metformin administration on Days 4 and 104)
Title
Maximum observed S-warfarin plasma concentration after single dose
Time Frame
(0-168 hours) after a single dose of warfarin without semaglutide exposure and at semaglutide steady state (warfarin administrations on Days 11 and 111)
Title
Maximum observed R-warfarin plasma concentration after single dose
Time Frame
(0-168 hours) after a single dose of warfarin without semaglutide exposure and at semaglutide steady state (warfarin administrations on Days 11 and 110)
Title
Incremental area under the INR (international normalised ratio) -curve
Time Frame
From 0 to 168 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Male and female, age between 18 and 55 years (both inclusive) at the time of signing informed consent
Body mass index (BMI) between 23 and 30 kg/m^2 (both inclusive)
Exclusion Criteria:
Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearingpotential and not using adequate contraceptive methods for the duration of the trial and for 5 weeks following the last dose of semaglutide. Adequate contraceptive measures are implants, injectables, combined oral contraceptives, hormonal intrauterine device, sexual abstinence or vasectomised partner
Any clinically significant disease history, in the opinion of the investigator, or systemic or organ disease including: pulmonary, gastrointestinal, hepatic, neurologic, renal, genitourinary and endocrine, dermatologic or hematologic diseases
Use of prescription or non-prescription systemic or topical medicinal products (including routine or non-routine vitamins or herbal products, but excluding paracetamol and contraceptives) within 3 weeks (or within 5 half-lives of the medicinal product, whichever is longest) prior to Visit 2
Smoking, drug or alcohol abuse
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Berlin
ZIP/Postal Code
10117
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
28349387
Citation
Hausner H, Derving Karsbol J, Holst AG, Jacobsen JB, Wagner FD, Golor G, Anderson TW. Effect of Semaglutide on the Pharmacokinetics of Metformin, Warfarin, Atorvastatin and Digoxin in Healthy Subjects. Clin Pharmacokinet. 2017 Nov;56(11):1391-1401. doi: 10.1007/s40262-017-0532-6.
Results Reference
result
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk
Learn more about this trial
Influence of Semaglutide on Pharmacokinetics and Pharmacodynamics of Warfarin and Pharmacokinetics of Metformin in Healthy Subjects
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