Safety of NNC 0123-0000-0338 in Healthy Subjects

NCT01334034 | Completed Phase 1

• 3 other identifiers: NN1953-3832U1111-1118-25252010-023885-38
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

This trial is conducted in Europe. The aim of this trial is to investigate the safety, tolerability, pharmacokinetics (the exposure of the trial drug in the body), and the pharmacodynamics (the effect of the investigated drug on the body) of NNC 0123-0000-0338 as tablets in healthy subjects.

Conditions

Diabetes; Healthy

Outcome Measures

Primary Outcomes (1)

• Number of adverse events

  from trial product administration and until completion of the dosing visit (Day 0 to Day 6)

Secondary Outcomes (2)

• Area under the serum insulin concentration-time curve

  from 0 to 120 hours after a single dose

• Area under the glucose infusion rate-time curve

  from 0 to 24 hours after a single dose

Study Arms (1)

Dose levels 1-7

EXPERIMENTAL

Drug: NNC 0123-0000-0338; Drug: placebo; Drug: insulin glargine

Interventions

NNC 0123-0000-0338 DRUG

Subjects will be randomised to receive a single dose of NNC 0123-0000-0338 (tablet), at 7 escalating dose levels. Progression to next dose level will be based on a safety evaluation.

Dose levels 1-7

placebo DRUG

Subjects will receive a single dose of placebo (tablet), as a comparator to NNC 0123-0000-0338 at all dose levels. Placebo dose remains the same at all dose levels.

Dose levels 1-7

insulin glargine DRUG

As an open label active comparator, a single dose of insulin glargine will be administered subcutaneously (under the skin), at all dose levels. Insulin glargine dose remains the same at all dose levels.

Dose levels 1-7

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male subject
• Body mass index (BMI) between 18 and 28 kg/m\^2 (both inclusive)

You may not qualify if:

• Known or suspected hypersensitivity to trial products or related products
• Presence of clinically significant acute gastrointestinal symptoms (e.g. nausea, vomiting, heartburn or diarrhoea) within 2 weeks prior to dosing, as judged by the trial physician
• Presence of any medical condition that may confound the results of the trial or pose an unacceptable risk to the subject by administering the trial product, as judged by the trial physician

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Novo Nordisk Investigational Site

Neuss, 41460, Germany

Location

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Insulin Glargine

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Global Clinical Registry (GCR, 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2011
• First Posted: April 12, 2011
• Study Start: April 11, 2011
• Primary Completion: September 16, 2011
• Study Completion: September 16, 2011
• Last Updated: March 1, 2017

Record last verified: 2017-02

Locations

DE (1)