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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 8 January 2018
Main ID:  NCT02210871
Date of registration: 06/08/2014
Prospective Registration: Yes
Primary sponsor: Novo Nordisk A/S
Public title: Investigating the Pharmacokinetics, Safety and Tolerability After a Single Subcutaneous Injection of Semaglutide in Subjects With Mild, Moderate or Severe Hepatic Impairment Compared to Subjects With Normal Hepatic Function
Scientific title: A Multi-centre, Open-label, Parallel-group Trial Investigating the Pharmacokinetics, Safety and Tolerability After a Single Subcutaneous Injection of Semaglutide in Subjects With Mild, Moderate or Severe Hepatic Impairment Compared to Subjects With Normal Hepatic Function
Date of first enrolment: August 7, 2014
Target sample size: 44
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02210871
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  Phase 1
Countries of recruitment
Poland Slovakia
Contacts
Name:     Global Clinical Registry GCR, 1452
Address: 
Telephone:
Email:
Affiliation:  Novo Nordisk A/S
Key inclusion & exclusion criteria

Inclusion Criteria:

- Male or female, age at least 18 years at the time of signing informed consent

- Body mass index (BMI) 18.5-40.0 kg/m^2 (both inclusive)

- Only for subjects with hepatic impairment (mild, moderate and severe): A diagnosis of
cirrhosis due to parenchymal liver disease, classified as Child-Pugh grade A,B or C as
assessed by investigator and which is confirmed and documented by medical history,
physical examination and at least one of the following: hepatic
ultrasound,computerised axial tomography (CT) scan, magnetic resonance imaging (MRI),
and/or liver biopsy

- Only for subjects with normal hepatic function: Subjects who are judged to be in good
general health based on physical examination, medical history, ECG, vital signs, and
the results of biochemistry, coagulation, haematology tests and urinalysis performed
during the screening visit, as judged by the investigator

Exclusion Criteria:

- Female who is pregnant, breast-feeding or intends to become pregnant or is of
child-bearing potential not using an adequate contraceptive method throughout the
trial including the follow-up period (adequate contraceptive measures as required by
local regulation or practice)

- Uncontrolled hypertension (defined as systolic blood pressure above or equal to 180
mmHg and/or diastolic blood pressure above or equal to 100 mmHg). If white-coat
hypertension is suspected at the screening visit a repeated measurement at the
screening visit is allowed

- Mental inability, unwillingness or language barrier precluding adequate understanding
of or compliance with trial procedures

- Donation of any blood or plasma in the past month or in excess of 400 mL within the 3
months preceding screening, or surgery or trauma with more than 400 mL blood loss
within the 3 months preceding screening



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Diabetes
Hepatic Impaired
Diabetes Mellitus, Type 2
Intervention(s)
Drug: semaglutide
Primary Outcome(s)
Area under the semaglutide plasma concentration-time curve [Time Frame: Day 1 - day 36]
Secondary Outcome(s)
Maximum observed semaglutide plasma concentration [Time Frame: Day 1 - day 36]
Number of treatment emergent adverse events (TEAEs) [Time Frame: Day 1 - day 36]
Secondary ID(s)
2009-011673-33
NN9535-3651
U1111-1149-3924
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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