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Completed

NCT Number: NCT02557620

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

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.

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Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Healthy Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novo Nordisk Investigational Site

Berlin, 10117, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

semaglutide

Drug

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

Placebo

Drug

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

Primary outcomes

  1. Area under the semaglutide concentration-time curves

    Time frame: At steady-state from 0 to168 hours after dosing on day 78

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Sep 23, 2015
Registry last updated
Jan 4, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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