NCT01796366

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 NNC0123-0000-0338 (insulin 338) in subjects with type 2 diabetes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P50-P75 for phase_1 diabetes

Timeline
Completed

Started Feb 2013

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

First Submitted

Initial submission to the registry

February 20, 2013

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 21, 2013

Completed
Same day until next milestone

Study Start

First participant enrolled

February 21, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 19, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 19, 2013

Completed
Last Updated

March 1, 2017

Status Verified

February 1, 2017

Enrollment Period

6 months

First QC Date

February 20, 2013

Last Update Submit

February 28, 2017

Conditions

DiabetesDiabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • Number of treatment emergent adverse events

    As recorded from first trial product administration (Day 1) and until Sub-visit 2A (Day 12) of the dosing visit

Secondary Outcomes (2)

  • Area under the serum insulin concentration-time curve

    During one dosing interval (0-24 hours) at steady-state (Day 10)

  • Area under the glucose infusion rate-time curve

    During one dosing interval (0-24 hours) at steady state (Day 10)

Study Arms (2)

Insulin 338 + placebo

EXPERIMENTAL
Drug: insulin 338 (GIPET I)Drug: placebo

Insulin glargine + placebo

ACTIVE COMPARATOR
Drug: insulin glargineDrug: placebo

Interventions

insulin 338 (GIPET I)DRUG

Each subject will be allocated to one of three dosing periods only. The subject will receive oral insulin 338 and placebo, administered subcutaneously (s.c., under the skin) once daily for 10 days at fixed dose levels.

Insulin 338 + placebo
placeboDRUG

S.c placebo administered in combination with insulin 338

Insulin 338 + placebo
insulin glargineDRUG

Each subject will be allocated to one of three dosing periods only. The subject will receive insulin glargine for s.c. administration and oral placebo once daily for 10 days at fixed dose levels.

Insulin glargine + placebo

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Male subject, or female subject of no childbearing potential, if surgically sterilized (i.e. tubal ligation, bilateral oopherectomies (removal of both ovaries and both fallopian tubes) or hysterectomised) for at least 3 months or if postmenopausal (i.e. as defined by amenorrhoea for at least 12 months prior to screening and documented by follicle stimulating hormone (FSH) levels above 40 U/L)
  • Body mass index (BMI) between 20.0 and 35.0 kg/m\^2 (both inclusive)
  • Type 2 diabetes mellitus (as diagnosed clinically) for 12 months or more

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 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)

Novo Nordisk Investigational Site

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

February 20, 2013

First Posted

February 21, 2013

Study Start

February 21, 2013

Primary Completion

August 19, 2013

Study Completion

August 19, 2013

Last Updated

March 1, 2017

Record last verified: 2017-02

Locations

DE(1)