NCT01527656

Brief Summary

This trial is conducted in Europe. The aim of this trial is to investigate the bioequivalence of two formulations of biphasic insulin aspart 70 in healthy male subjects.

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 Dec 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

December 1, 2003

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2004

Completed
8 years until next milestone

First Submitted

Initial submission to the registry

February 2, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 7, 2012

Completed
Last Updated

January 6, 2017

Status Verified

January 1, 2017

Enrollment Period

2 months

First QC Date

February 2, 2012

Last Update Submit

January 5, 2017

Conditions

DiabetesHealthy

Outcome Measures

Primary Outcomes (2)

  • Area under the insulin aspart curve in the interval from 0-16 hours

  • Cmax, maximum insulin aspart concentration

Secondary Outcomes (5)

  • tmax, time to maximum insulin aspart concentration

  • Area under the insulin aspart curve

  • Mean residence time (MRT)

  • t½, terminal half-life

  • Incidence of hypoglycaemic events

Study Arms (2)

Formulation A

EXPERIMENTAL
Drug: biphasic insulin aspart 70

Formulation B

EXPERIMENTAL
Drug: biphasic insulin aspart 70

Interventions

biphasic insulin aspart 70DRUG

A single dose administrated subcutaneously (s.c., under the skin) on two separate dosing visits. A wash-out period of 6-12 days will take place between dosing visits

Formulation AFormulation B

Eligibility Criteria

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

You may qualify if:

  • Considered generally healthy upon completion of medical history and physical examination, as judged by the investigator
  • Body Mass Index (BMI) between 19.0-30.0 kg/m\^2
  • Glycohemoglobin (HbA1c) within laboratory normal range
  • Non-smokers

You may not qualify if:

  • Clinically significant abnormal haematology, biochemistry, urinalysis or ECG (electrocardiogram) screening tests, as judged by the investigator
  • Liver enzyme values (ALAT and ASAT) exceeding 2 times the upper reference limit according to the local laboratory
  • A history of any illness that, in the opinion of the Investigator and/or Sponsor, might confound the results of the trial or pose additional risk in administering the investigational product to the subject
  • History of or current addiction to alcohol or drugs of abuse as determined by the investigator (positive urine drug screen and breath alcohol screen)
  • HIV (human immunodeficiency virus), Hepatitis B or C positive
  • Subjects with a first-degree relative with diabetes mellitus
  • A history of multiple and/or severe allergies to drugs or foods or a history of anaphylactic reactions
  • Known or suspected allergy to trial product or related products
  • Smoking during the past three months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novo Nordisk Investigational Site

Neuss, 41460, Germany

Location

Related Publications (1)

  • Hanefeld M, Fischer S, Julius U, Schulze J, Schwanebeck U, Schmechel H, Ziegelasch HJ, Lindner J. Risk factors for myocardial infarction and death in newly detected NIDDM: the Diabetes Intervention Study, 11-year follow-up. Diabetologia. 1996 Dec;39(12):1577-83. doi: 10.1007/s001250050617.

    PMID: 8960845RESULT

Related Links

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

insulin aspart, insulin aspart protamine drug combination 30:70

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

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

February 2, 2012

First Posted

February 7, 2012

Study Start

December 1, 2003

Primary Completion

February 1, 2004

Study Completion

February 1, 2004

Last Updated

January 6, 2017

Record last verified: 2017-01

Locations

DE(1)