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

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

Sponsors

Lead Sponsor: Novo Nordisk A/S

Source Novo Nordisk A/S
Brief 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.

Overall Status Completed
Start Date June 2015
Completion Date December 2015
Primary Completion Date December 2015
Phase Phase 1
Study Type Interventional
Primary Outcome
Measure Time Frame
Number of treatment-emergent adverse events From the time of trial product administration and until 12 days after trial product administration
Secondary Outcome
Measure Time Frame
Area under the serum insulin concentration-time curve From 0 to 288 hours after a single dose (SD)
Area under the glucose infusion rate-time curve From 0 to 24 hours after a single dose
Enrollment 84
Condition
Intervention

Intervention Type: Drug

Intervention Name: Insulin 320

Description: 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.

Arm Group Label: Level 1-7 escalating doses

Intervention Type: Drug

Intervention Name: insulin glargine

Description: 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.

Arm Group Label: Level 1-7 escalating doses

Intervention Type: Drug

Intervention Name: placebo

Description: Subjects will be randomised to receive a single dose of placebo orally as a comparator Insulin 320, at all dose levels.

Arm Group Label: Level 1-7 escalating doses

Eligibility

Criteria:

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

Gender: Male

Minimum Age: 18 Years

Maximum Age: 55 Years

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Global Clinical Registry (GCR, 1452) Study Director Novo Nordisk A/S
Location
Facility:
Location Countries

Germany

Verification Date

July 2016

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: Level 1-7 escalating doses

Type: Experimental

Study Design Info

Allocation: Randomized

Intervention Model: Single Group Assignment

Primary Purpose: Treatment

Masking: Double (Participant, Investigator)

Source: ClinicalTrials.gov