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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02557620
• Other study ID #: NN9535-4215
• Secondary ID: 2014-005171-84U1
• Status: Completed
• Phase: Phase 1
• First received: September 22, 2015
• Last updated: January 2, 2017
• Start date: September 2015
• Est. completion date: April 2016

Study information

• Verified date: January 2017
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 113
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes
• Healthy

Intervention

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

Locations

Country	Name	City	State
Germany	Novo Nordisk Investigational Site	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the semaglutide concentration-time curves		At steady-state from 0 to168 hours after dosing on day 78	No
Secondary	Maximum observed semaglutide plasma concentration		At steady-state derived from the concentration-time curves, within 168 hours from day 78	No
Secondary	Number of treatment emergent adverse events (TEAEs)		From baseline (day 1, post-dose) to last follow-up visit (day 120)	No
Secondary	Area under the the single dose concentration-time curve		From 0 to 300 min after administration of paracetamol (1.5 g) at day 51	No
Secondary	Area under the the single dose concentration-time curve		From 0 to 300 min after administration of paracetamol (1.5 g) at day 79	No

External Links

•   Clinical Trials at Novo Nordisk