NCT01707160

Brief Summary

This trial is conducted in Europe. The aim of this trial is to investigate the pharmacokinetics and pharmacodynamics of insulin X14 30/70 PreMix compared to human insulin 30/70 PreMix in healthy volunteers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at P25-P50 for phase_1 diabetes

Timeline
Completed

Started Nov 1995

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

November 1, 1995

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 1995

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 1995

Completed
16.9 years until next milestone

First Submitted

Initial submission to the registry

October 10, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 16, 2012

Completed
Last Updated

January 4, 2017

Status Verified

January 1, 2017

Enrollment Period

1 month

First QC Date

October 10, 2012

Last Update Submit

January 3, 2017

Conditions

DiabetesHealthy

Outcome Measures

Primary Outcomes (1)

  • Area under the Curve

Secondary Outcomes (5)

  • Maximum insulin concentration (Cmax)

  • Time to maximum insulin concentration (tmax)

  • Minimum glucose concentration (Cmin(glu))

  • Time to minimum glucose concentration (tmin(glu))

  • Adverse events

Study Arms (2)

Treatment period 1

EXPERIMENTAL
Drug: biphasic insulin aspart 30Drug: biphasic human insulin 30

Treatment period 2

ACTIVE COMPARATOR
Drug: biphasic insulin aspart 30Drug: biphasic human insulin 30

Interventions

biphasic insulin aspart 30DRUG

One single dose of each trial drug separated by 4-10 days injected subcutaneously (s.c, under the skin) in random order

Treatment period 1Treatment period 2
biphasic human insulin 30DRUG

One single dose of each trial drug separated by 4-10 days injected subcutaneously (s.c, under the skin) in random order

Treatment period 1Treatment period 2

Eligibility Criteria

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

You may qualify if:

  • Non-smokers
  • BMI (body mass index) maximum 27 kg/m\^2
  • HbA1c (glycosylated haemoglobin A1c): 3.4-6.1%
  • FBG (fasting blood glucose) maximum 6.0 mmol/L

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novo Nordisk Investigational Site

Leeds, LS2 9NG, United Kingdom

Location

Related Publications (1)

  • Jacobsen LV, Sogaard B, Riis A. Pharmacokinetics and pharmacodynamics of a premixed formulation of soluble and protamine-retarded insulin aspart. Eur J Clin Pharmacol. 2000 Aug;56(5):399-403. doi: 10.1007/s002280000159.

    PMID: 11009049RESULT

Related Links

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

insulin aspart, insulin aspart protamine drug combination 30:70biphasic human insulin 30

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

October 10, 2012

First Posted

October 16, 2012

Study Start

November 1, 1995

Primary Completion

December 1, 1995

Study Completion

December 1, 1995

Last Updated

January 4, 2017

Record last verified: 2017-01

Locations

GB(1)