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Comparing Semaglutide Administered Subcutaneously Once Daily to Semaglutide Administered Subcutaneously Once Weekly

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ClinicalTrials.gov Identifier: NCT02557620
Recruitment Status : Completed
First Posted : September 23, 2015
Last Update Posted : January 4, 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 compare the steady-state exposure of semaglutide administered subcutaneously once daily to semaglutide administered subcutaneously once weekly in healthy subjects.

Condition or disease Intervention/treatment Phase
Diabetes Healthy Drug: semaglutide Drug: placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 113 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomised, Double-blind, Placebo Controlled, Double Dummy, Single-centre Trial in Healthy Subjects Comparing the Steady-state Exposure of Semaglutide Administered Subcutaneously Once Daily to Semaglutide Administered Subcutaneously Once Weekly
Study Start Date : September 2015
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Semaglutide

Arm Intervention/treatment
Experimental: semaglutide OD + placebo semaglutide OW Drug: semaglutide
Administered subcutaneously (s.c., under the skin)once daily or once weekly.

Drug: placebo
Administered subcutaneously (s.c., under the skin)once daily or once weekly.

Placebo Comparator: placebo semaglutide OW + placebo semaglutide OD Drug: placebo
Administered subcutaneously (s.c., under the skin)once daily or once weekly.

Experimental: semaglutide OW + placebo semaglutide OD Drug: semaglutide
Administered subcutaneously (s.c., under the skin)once daily or once weekly.

Drug: placebo
Administered subcutaneously (s.c., under the skin)once daily or once weekly.




Primary Outcome Measures :
  1. Area under the semaglutide concentration-time curves [ Time Frame: At steady-state from 0 to168 hours after dosing on day 78 ]

Secondary Outcome Measures :
  1. Maximum observed semaglutide plasma concentration [ Time Frame: At steady-state derived from the concentration-time curves, within 168 hours from day 78 ]
  2. Number of treatment emergent adverse events (TEAEs) [ Time Frame: From baseline (day 1, post-dose) to last follow-up visit (day 120) ]
  3. Area under the the single dose concentration-time curve [ Time Frame: From 0 to 300 min after administration of paracetamol (1.5 g) at day 51 ]
  4. Area under the the single dose concentration-time curve [ Time Frame: From 0 to 300 min after administration of paracetamol (1.5 g) at day 79 ]


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male or female, aged 18-55 years (both inclusive) at the time of signing informed consent
  • Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, ECG and clinical laboratory tests performed during the screeningvisit, as judged by the investigator
  • Body mass index (BMI) between 20.0 and 29.9 kg/m^2 (both inclusive)
  • HbA1c (glycosylated haemoglobin) below 6.5%

Exclusion Criteria:

  • Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive method throughout the trial including the 5 weeks follow-up period (adequate contraceptive measures as required by local regulation or practice)
  • Any disorder which in the investigator's opinion might jeopardise subject's safety, evaluation of results, or compliance with the protocol
  • History of pancreatitis (acute or chronic)
  • Screening calcitonin equal or above 50 ng/L
  • Family or personal history of Multiple Endocrine Neoplasia Type 2 (MEN2) or Medullary Thyroid Carcinoma (MTC)

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): NCT02557620


Locations
Germany
Novo Nordisk Investigational Site
Berlin, Germany, 10117
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT02557620     History of Changes
Other Study ID Numbers: NN9535-4215
2014-005171-84 ( EudraCT Number )
U1111-1164-2741 ( Other Identifier: WHO )
First Posted: September 23, 2015    Key Record Dates
Last Update Posted: January 4, 2017
Last Verified: January 2017