A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC0148-0000-0287 in Healthy Subjects

February 28, 2017 updated by: Novo Nordisk A/S
This trial is conducted in Europe. The aim of this first human dose trial is to investigate the safety, tolerability, pharmacodynamic (the effect of the investigated drug on the body) and pharmacokinetic (exposure of the trial drug in the body) properties of NNC0148-0000-0287 (insulin 287) in a GIPET® I tablet formulation in healthy subjects.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

84

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Neuss, Germany, 41460
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Body mass index 18.0-28.0 kg/m^2
  • Subject who is considered to be healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram (ECG) 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 randomised
  • Presence of clinically significant acute gastrointestinal symptoms (e.g. nausea, vomiting, heartburn or diarrhoea) within 2 weeks prior to dosing, as judged by the investigator
  • Any chronic disorder or severe disease which, in the opinion of the investigator, might jeopardise subject's safety or compliance with the protocol

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dose level 1
Each subject will be randomly assigned to receive either insulin 287, placebo or insulin glargine within the dose group.
Drug: insulin 287
Orally administered insulin 287. The subjects will be dosed in the fasting state and receive one single dose followed by a 24-hour euglycaemic glucose clamp.
Drug: insulin glargine
Insulin glargine administered subcutaneously (s.c., under the skin) at fixed dose levels.
Drug: placebo
Oral placebo adminstered corresponding to insulin 287 treatment
Experimental: Dose level 2
Each subject will be randomly assigned to receive either insulin 287, placebo or insulin glargine within the dose group.
Drug: insulin 287
Orally administered insulin 287. The subjects will be dosed in the fasting state and receive one single dose followed by a 24-hour euglycaemic glucose clamp.
Drug: insulin glargine
Insulin glargine administered subcutaneously (s.c., under the skin) at fixed dose levels.
Drug: placebo
Oral placebo adminstered corresponding to insulin 287 treatment
Experimental: Dose level 3
Each subject will be randomly assigned to receive either insulin 287, placebo or insulin glargine within the dose group.
Drug: insulin 287
Orally administered insulin 287. The subjects will be dosed in the fasting state and receive one single dose followed by a 24-hour euglycaemic glucose clamp.
Drug: insulin glargine
Insulin glargine administered subcutaneously (s.c., under the skin) at fixed dose levels.
Drug: placebo
Oral placebo adminstered corresponding to insulin 287 treatment
Experimental: Dose level 4
Each subject will be randomly assigned to receive either insulin 287, placebo or insulin glargine within the dose group.
Drug: insulin 287
Orally administered insulin 287. The subjects will be dosed in the fasting state and receive one single dose followed by a 24-hour euglycaemic glucose clamp.
Drug: insulin glargine
Insulin glargine administered subcutaneously (s.c., under the skin) at fixed dose levels.
Drug: placebo
Oral placebo adminstered corresponding to insulin 287 treatment
Experimental: Dose level 5
Each subject will be randomly assigned to receive either insulin 287, placebo or insulin glargine within the dose group.
Drug: insulin 287
Orally administered insulin 287. The subjects will be dosed in the fasting state and receive one single dose followed by a 24-hour euglycaemic glucose clamp.
Drug: insulin glargine
Insulin glargine administered subcutaneously (s.c., under the skin) at fixed dose levels.
Drug: placebo
Oral placebo adminstered corresponding to insulin 287 treatment
Experimental: Dose level 6
Each subject will be randomly assigned to receive either insulin 287, placebo or insulin glargine within the dose group.
Drug: insulin 287
Orally administered insulin 287. The subjects will be dosed in the fasting state and receive one single dose followed by a 24-hour euglycaemic glucose clamp.
Drug: insulin glargine
Insulin glargine administered subcutaneously (s.c., under the skin) at fixed dose levels.
Drug: placebo
Oral placebo adminstered corresponding to insulin 287 treatment
Experimental: Dose level 7
Each subject will be randomly assigned to receive either insulin 287, placebo or insulin glargine within the dose group.
Drug: insulin 287
Orally administered insulin 287. The subjects will be dosed in the fasting state and receive one single dose followed by a 24-hour euglycaemic glucose clamp.
Drug: insulin glargine
Insulin glargine administered subcutaneously (s.c., under the skin) at fixed dose levels.
Drug: placebo
Oral placebo adminstered corresponding to insulin 287 treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of adverse events (AEs)
Time Frame: As recorded from trial product administration and until completion of Sub-visit 2G (Day 13)
As recorded from trial product administration and until completion of Sub-visit 2G (Day 13)

Secondary Outcome Measures

Outcome Measure
Time Frame
Area under the glucose infusion rate (GIR)-time curve
Time Frame: From 0 to 24 hours after a single dose
From 0 to 24 hours after a single dose
Area under the serum insulin concentration-time curve
Time Frame: From 0 to 648 hours after a single dose
From 0 to 648 hours after a single dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 4, 2013

Primary Completion (Actual)

September 6, 2013

Study Completion (Actual)

September 6, 2013

Study Registration Dates

First Submitted

March 8, 2013

First Submitted That Met QC Criteria

March 8, 2013

First Posted (Estimate)

March 12, 2013

Study Record Updates

Last Update Posted (Actual)

March 1, 2017

Last Update Submitted That Met QC Criteria

February 28, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN1956-4014
  • 2012-003048-66 (EudraCT Number)
  • U1111-1132-1018 (Other Identifier: WHO)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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