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

• Sponsor: Novo Nordisk A/S (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02557620
• Collaborator: (none)
• Enrollment: 113
• Location: 1
• Arms: 3
• Duration (Months): 7
• Patients Per Site Per Month: 16.1

Study Details

Study Description

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 Design

• Study Type: Interventional
• 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: Sep 1, 2015
• Actual Primary Completion Date: Apr 1, 2016
• Actual Study Completion Date: Apr 1, 2016

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

1. Maximum observed semaglutide plasma concentration [At steady-state derived from the concentration-time curves, within 168 hours from day 78]

2. Number of treatment emergent adverse events (TEAEs) [From baseline (day 1, post-dose) to last follow-up visit (day 120)]

3. Area under the the single dose concentration-time curve [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 [From 0 to 300 min after administration of paracetamol (1.5 g) at day 79]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Clinical Trials at Novo Nordisk

Publications

None provided.

• Responsible Party: Novo Nordisk A/S
• ClinicalTrials.gov Identifier: NCT02557620
• Other Study ID Numbers: NN9535-4215; 2014-005171-84; U1111-1164-2741
• First Posted: Sep 23, 2015
• Last Update Posted: Jan 4, 2017
• Last Verified: Jan 1, 2017

Study Results

No Results Posted as of Jan 4, 2017