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

NCT ID: NCT02557620

Last Updated: 2017-01-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 113 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2016-04-30

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.

Conditions

Diabetes; Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

semaglutide OD + placebo semaglutide OW

Group Type: EXPERIMENTAL

semaglutide

Intervention Type: DRUG

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

placebo

Intervention Type: DRUG

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

placebo semaglutide OW + placebo semaglutide OD

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

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

semaglutide OW + placebo semaglutide OD

Group Type: EXPERIMENTAL

semaglutide

Intervention Type: DRUG

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

placebo

Intervention Type: DRUG

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

Interventions

semaglutide

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

Intervention Type: DRUG

placebo

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

Intervention Type: DRUG

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Novo Nordisk A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Global Clinical Registry (GCR, 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

Novo Nordisk Investigational Site

Berlin, , Germany

Countries

Germany

Related Links

http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

2014-005171-84

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1164-2741

Identifier Type: OTHER

Identifier Source: secondary_id

NN9535-4215

Identifier Type: -

Identifier Source: org_study_id