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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

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ClinicalTrials.gov Identifier: NCT02210871
Recruitment Status : Completed
First Posted : August 7, 2014
Last Update Posted : December 21, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
This trial is conducted in Europe. The aim of this trial is to investigate the pharmacokinetics (the exposure of the trial drug in the body), safety and tolerability after a single injection of semaglutide in subjects with mild, moderate or severe hepatic impairment compared to subjects with normal hepatic function.

Condition or disease Intervention/treatment Phase
Diabetes Diabetes Mellitus, Type 2 Hepatic Impaired Drug: semaglutide Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : August 7, 2014
Actual Primary Completion Date : June 3, 2015
Actual Study Completion Date : June 3, 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Semaglutide

Arm Intervention/treatment
Experimental: Normal hepatic function Drug: semaglutide
All subjects will be treated with a single subcutane (s.c., under the skin) injection of 0.5 mg semaglutide.

Experimental: Mild hepatic impairment Drug: semaglutide
All subjects will be treated with a single subcutane (s.c., under the skin) injection of 0.5 mg semaglutide.

Experimental: Moderate hepatic impairment Drug: semaglutide
All subjects will be treated with a single subcutane (s.c., under the skin) injection of 0.5 mg semaglutide.

Experimental: Severe hepatic impairment Drug: semaglutide
All subjects will be treated with a single subcutane (s.c., under the skin) injection of 0.5 mg semaglutide.




Primary Outcome Measures :
  1. Area under the semaglutide plasma concentration-time curve [ Time Frame: Day 1 - day 36 ]

Secondary Outcome Measures :
  1. Maximum observed semaglutide plasma concentration [ Time Frame: Day 1 - day 36 ]
  2. Number of treatment emergent adverse events (TEAEs) [ Time Frame: Day 1 - day 36 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02210871


Locations
Poland
Novo Nordisk Investigational Site
Warszawa, Poland, 02-507
Novo Nordisk Investigational Site
Wolomin, Poland, 05-200
Slovakia
Novo Nordisk Investigational Site
Bratislava, Slovakia, 83101
Novo Nordisk Investigational Site
Bratislava, Slovakia, 833 05
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry GCR, 1452 Novo Nordisk A/S

Additional Information:
Publications of Results:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT02210871     History of Changes
Other Study ID Numbers: NN9535-3651
U1111-1149-3924 ( Other Identifier: WHO )
2009-011673-33 ( EudraCT Number )
First Posted: August 7, 2014    Key Record Dates
Last Update Posted: December 21, 2017
Last Verified: December 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases