NCT01597713

Brief Summary

This trial is conducted in Europe. The aim of this trial is to investigate the safety, tolerability, pharmacokinetics (exposure of drug) and pharmacodynamics (effect of drug) of NNC 0148-0000-0362 as tablets in healthy volunteers. The trial consists of two parts. In part 1, single escalating doses of NNC 0148-0000-0362, placebo or insulin glargine is given. In part 2, subjects will receive single doses of NNC 0148-0000-0362 administered orally or intravenously.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
83

participants targeted

Target at P75+ for phase_1 diabetes

Timeline
Completed

Started May 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

May 10, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 14, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

May 29, 2015

Status Verified

May 1, 2015

Enrollment Period

5 months

First QC Date

May 10, 2012

Last Update Submit

May 28, 2015

Conditions

DiabetesDiabetes Mellitus, Type 2Healthy

Outcome Measures

Primary Outcomes (1)

  • Number of adverse events

    Recorded from trial product administration and until completion of Sub-visit G (i.e. Day 13) of the dosing visit

Secondary Outcomes (3)

  • Area under the serum insulin concentration-time curve (with Trial part 1)

    From 0 to 288 hours after a single oral dose of NNC 0148-0000-0362 or a single subcutaneous (s.c.) dose of insulin glargine, respectively

  • Area under the glucose infusion rate (GIR)-time curve (Trial part 1)

    From 0 to 24 hours after a single oral dose of NNC 0148-0000-0362 or a single s.c. dose of insulin glargine, respectively

  • Area under the serum insulin concentration-time curve (Trial part 2)

    From 0 hours to infinity after a single dose of NNC 0148-0000-0362 administered orally as 1 and 3 tablets and intravenously, respectively

Study Arms (2)

Part 1, level 1-7 escalating doses

EXPERIMENTAL
Drug: NNC 0148-0000-0362Drug: insulin glargineDrug: placebo

Part 2, cross-over

EXPERIMENTAL
Drug: NNC 0148-0000-0362

Interventions

NNC 0148-0000-0362DRUG

Subjects will be randomised to receive a single dose of NNC 0148-0000-0362 orally within each dose group

Part 1, level 1-7 escalating doses
insulin glargineDRUG

As an active comparator, one standard dose will be given subcutaneously (s.c., under the skin) within each dose group

Part 1, level 1-7 escalating doses
placeboDRUG

Subjects will receive a single dose of oral placebo within each dose group

Part 1, level 1-7 escalating doses

Eligibility Criteria

Age18 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Body mass index 18-28 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, electrocardiogram (ECG) and clinical laboratory tests performed during the screening visit, as judged by the investigator

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Neuss, 41460, Germany

Location

Related Links

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 2

Interventions

Insulin Glargine

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-ActingInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino 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

May 10, 2012

First Posted

May 14, 2012

Study Start

May 1, 2012

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

May 29, 2015

Record last verified: 2015-05

Locations

DE(1)