NCT01486914

Brief Summary

This trial is conducted in Europe. The aim of this trial is to compare insulin aspart produced by current process and the NN2000 process.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at P25-P50 for phase_1 diabetes

Timeline
Completed

Started Jan 2003

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

January 19, 2003

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 24, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 24, 2003

Completed
8.8 years until next milestone

First Submitted

Initial submission to the registry

December 5, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 7, 2011

Completed
Last Updated

March 1, 2017

Status Verified

February 1, 2017

Enrollment Period

1 month

First QC Date

December 5, 2011

Last Update Submit

February 28, 2017

Conditions

DiabetesHealthy

Outcome Measures

Primary Outcomes (1)

  • Area under the Curve (AUC) (insulin aspart)

Secondary Outcomes (4)

  • Cmax (maximum plasma concentration)

  • Terminal half life (t½)

  • Incident of hypoglycaemic episodes

  • Adverse events

Study Arms (2)

NN2000

EXPERIMENTAL
Drug: insulin aspart

IAsp

ACTIVE COMPARATOR
Drug: insulin aspart

Interventions

insulin aspartDRUG

Single dose of each formulation administrated subcutaneously (s.c., under the skin) at two separate dosing visits

IAspNN2000

Eligibility Criteria

Age18 Years - 50 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy
  • Caucasian
  • Normal findings in medical history and physical examination unless the investigator considers any abnormality to be clinically irrelevant
  • Fasting blood glucose below or equal to 6 mmol/L
  • Body mass index (BMI) 22.0-27.0 kg/m\^2 (both inclusive)

You may not qualify if:

  • Participated in another clinical study with an investigational drug within the last 4 weeks
  • Any condition requiring the regular use of any medication, including herbal remedies, over the counter medicines and vitamins. Occasional paracetamol is acceptable
  • Known or suspected allergy to the trial product or related products
  • Family history of type 2 diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novo Nordisk Investigational Site

Manchester, M15 6SH, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Insulin Aspart

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Short-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
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 5, 2011

First Posted

December 7, 2011

Study Start

January 19, 2003

Primary Completion

February 24, 2003

Study Completion

February 24, 2003

Last Updated

March 1, 2017

Record last verified: 2017-02

Locations

GB(1)