A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Insulin 320 in Healthy Subjects

Healthy Clinical Trial

Official title:

A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Insulin 320 in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02479022
• Other study ID #: NN1957-4195
• Secondary ID: 2014-003918-92U1
• Status: Completed
• Phase: Phase 1
• First received: June 19, 2015
• Last updated: July 29, 2016
• Start date: June 2015
• Est. completion date: December 2015

Study information

• Verified date: July 2016
• 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 the trial is to investigate the safety, tolerability, pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of insulin 320 in healthy subjects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Male, aged 18-55 years (both inclusive) at the time of signing informed consent

• Body mass index 18.5-28.0 kg/m^2 (both inclusive)

• Subject who is considered to be healthy based on the medical history, physical examination, and the results of vital signs, electrocardiograms and clinical laboratory tests performed during the screening visit, as judged by the investigator

Exclusion Criteria:

• Known or suspected hypersensitivity to trial products or related products

• Previous participation in this trial. Participation is defined as signed informed consent

• Any disorder which, in the opinion of the investigator, might jeopardise subject's safety or compliance with the protocol

• Presence of clinically significant acute and chronic gastrointestinal symptoms (e.g. nausea, vomiting, heartburn or diarrhoea) as judged by the investigator

Study Design

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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Healthy

Intervention

Drug:
• Insulin 320
Subjects will be randomised to receive a single dose of Insulin 320 orally, at 7 escalating dose levels from 300 nmol to 21600 nmol. Progression to next dose level will be based on a safety evaluation.
• insulin glargine
As an open label active comparator, subjects will be randomised to receive a single dose of insulin glargine subcutaneously (s.c., under the skin), at all dose levels. The insulin glargine dose will be the same at all dose levels.
• placebo
Subjects will be randomised to receive a single dose of placebo orally as a comparator Insulin 320, at all dose levels.

Locations

Country	Name	City	State
n/a

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	Number of treatment-emergent adverse events		From the time of trial product administration and until 12 days after trial product administration	No
Secondary	Area under the serum insulin concentration-time curve		From 0 to 288 hours after a single dose (SD)	No
Secondary	Area under the glucose infusion rate-time curve		From 0 to 24 hours after a single dose	No

External Links

•   Clinical Trials at Novo Nordisk