NCT02557620

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
113

participants targeted

Target at P75+ for phase_1 diabetes

Timeline
Completed

Started Sep 2015

Typical duration for phase_1 diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

September 22, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 23, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

January 4, 2017

Status Verified

January 1, 2017

Enrollment Period

7 months

First QC Date

September 22, 2015

Last Update Submit

January 2, 2017

Conditions

DiabetesHealthy

Outcome Measures

Primary Outcomes (1)

  • Area under the semaglutide concentration-time curves

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

Secondary Outcomes (4)

  • Maximum observed semaglutide plasma concentration

    At steady-state derived from the concentration-time curves, within 168 hours from day 78

  • Number of treatment emergent adverse events (TEAEs)

    From baseline (day 1, post-dose) to last follow-up visit (day 120)

  • Area under the the single dose concentration-time curve

    From 0 to 300 min after administration of paracetamol (1.5 g) at day 51

  • Area under the the single dose concentration-time curve

    From 0 to 300 min after administration of paracetamol (1.5 g) at day 79

Study Arms (3)

semaglutide OD + placebo semaglutide OW

EXPERIMENTAL
Drug: semaglutideDrug: placebo

placebo semaglutide OW + placebo semaglutide OD

PLACEBO COMPARATOR
Drug: placebo

semaglutide OW + placebo semaglutide OD

EXPERIMENTAL
Drug: semaglutideDrug: placebo

Interventions

semaglutideDRUG

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

semaglutide OD + placebo semaglutide OWsemaglutide OW + placebo semaglutide OD
placeboDRUG

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

placebo semaglutide OW + placebo semaglutide ODsemaglutide OD + placebo semaglutide OWsemaglutide OW + placebo semaglutide OD

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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%

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novo Nordisk Investigational Site

Berlin, 10117, Germany

Location

Related Links

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Global Clinical Registry (GCR, 1452)

    Novo Nordisk A/S

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 22, 2015

First Posted

September 23, 2015

Study Start

September 1, 2015

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

January 4, 2017

Record last verified: 2017-01

Locations

DE(1)