NCT02162407

Brief Summary

This study is conducted in Europe. The aim of this study is to estimate the relationship between pharmacodynamic and interstitial pharmacokinetic steady state following intravenous (i.v.) administration of insulin detemir and human soluble insulin.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
13

participants targeted

Target at below P25 for phase_1 diabetes

Timeline
Completed

Started Oct 1999

Shorter than P25 for phase_1 diabetes

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

October 1, 1999

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 1999

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 1999

Completed
14.5 years until next milestone

First Submitted

Initial submission to the registry

May 22, 2014

Completed
21 days until next milestone

First Posted

Study publicly available on registry

June 12, 2014

Completed
Last Updated

June 12, 2014

Status Verified

June 1, 2014

Enrollment Period

2 months

First QC Date

May 22, 2014

Last Update Submit

June 10, 2014

Conditions

DiabetesHealthy

Outcome Measures

Primary Outcomes (1)

  • Steady state glucose infusion rate (GIR) / interstitial insulin steady state concentration

    8 hours

Secondary Outcomes (4)

  • Steady state glucose infusion rate (GIR)

    8 hours

  • Steady state insulin interstitial concentration

    8 hours

  • Ratio of steady state serum insulin concentration to interstitial insulin concentration

    8 hours

  • Insulin concentration profiles

    8 hours

Study Arms (3)

Insulin detemir 60 pmol/kg/min

EXPERIMENTAL

Subjects will be randomised to one of six treatment sequences (the 3 test drugs given at 3 different trial days 7-28 days apart in randomised order)

Drug: insulin detemir

Insulin detemir 120 pmol/kg/min

EXPERIMENTAL

Subjects will be randomised to one of six treatment sequences (the 3 test drugs given at 3 different trial days 7-28 days apart in randomised order)

Drug: insulin detemir

Human insulin 6 pmol/kg/min

ACTIVE COMPARATOR

Subjects will be randomised to one of six treatment sequences (the 3 test drugs given at 3 different trial days 7-28 days apart in randomised order)

Drug: human soluble insulin

Interventions

insulin detemirDRUG

Given as intravenous infusion (i.v.) over a period of 8 hours during euglycaemic clamp

Insulin detemir 120 pmol/kg/minInsulin detemir 60 pmol/kg/min
human soluble insulinDRUG

Given as intravenous infusion (i.v.) over a period of 8 hours during euglycaemic clamp

Human insulin 6 pmol/kg/min

Eligibility Criteria

Age19 Years - 50 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy males between 19 and 50 years inclusive
  • The subject must give signed informed consent before any trial related activity. (Trial related activities are any procedures that would not have been performed during the normal management of the subject)
  • Body Mass Index (BMI) below 27 kg/m\^2
  • Fasting blood glucose maximum 6 mmol/l

You may not qualify if:

  • Participation in any other clinical trial involving other investigational products within the last 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Graz, 8036, Austria

Location

Related Links

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Insulin Detemir

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
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 22, 2014

First Posted

June 12, 2014

Study Start

October 1, 1999

Primary Completion

December 1, 1999

Study Completion

December 1, 1999

Last Updated

June 12, 2014

Record last verified: 2014-06

Locations

AU(1)