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

NCT01809184 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2017-03-01

No results posted yet for this study

Summary

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.

Conditions

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Global Clinical Registry (GCR, 1452) · Novo Nordisk A/S

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-03-04
Primary Completion
2013-09-06
Completion
2013-09-06

Countries

  • Germany

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01809184 on ClinicalTrials.gov