NCT01536028

Brief Summary

This trial is conducted in Europe. The aim of this trial is to compare the pharmacodynamics and pharmacokinetics after a single dose of biphasic insulin aspart 30, biphasic insulin aspart 50, biphasic insulin aspart 70 and insulin aspart in subjects with type 1 diabetes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for phase_1 diabetes

Timeline
Completed

Started Apr 2006

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

April 1, 2006

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2006

Completed
5.6 years until next milestone

First Submitted

Initial submission to the registry

February 15, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 20, 2012

Completed
Last Updated

January 6, 2017

Status Verified

January 1, 2017

Enrollment Period

3 months

First QC Date

February 15, 2012

Last Update Submit

January 5, 2017

Conditions

DiabetesDiabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

  • Area under the GIR (glucose infusion rate)-curves in the first two hours post-dosing

Secondary Outcomes (11)

  • Maximum GIR value

  • Time to maximum GIR value

  • Area under the GIR-curves

  • Maximum drug concentration for insulin aspart (IAsp)

  • Time to maximum IAsp concentration

  • +6 more secondary outcomes

Study Arms (4)

BIAsp 30

ACTIVE COMPARATOR
Drug: biphasic insulin aspart 30Drug: biphasic insulin aspart 50Drug: biphasic insulin aspart 70Drug: insulin aspart

BIAsp 50

EXPERIMENTAL
Drug: biphasic insulin aspart 30Drug: biphasic insulin aspart 50Drug: biphasic insulin aspart 70Drug: insulin aspart

BIAsp 70

EXPERIMENTAL
Drug: biphasic insulin aspart 30Drug: biphasic insulin aspart 50Drug: biphasic insulin aspart 70Drug: insulin aspart

IAsp

ACTIVE COMPARATOR
Drug: biphasic insulin aspart 30Drug: biphasic insulin aspart 50Drug: biphasic insulin aspart 70Drug: insulin aspart

Interventions

biphasic insulin aspart 30DRUG

A single dose administrated subcutaneously (s.c., under the skin) on four separate dosing visits in random order with a washout of 1-2 weeks in-between

BIAsp 30BIAsp 50BIAsp 70IAsp
biphasic insulin aspart 50DRUG

A single dose administrated subcutaneously (s.c., under the skin) on four separate dosing visits in random order with a washout of 1-2 weeks in-between

BIAsp 30BIAsp 50BIAsp 70IAsp
biphasic insulin aspart 70DRUG

A single dose administrated subcutaneously (s.c., under the skin) on four separate dosing visits in random order with a washout of 1-2 weeks in-between

BIAsp 30BIAsp 50BIAsp 70IAsp
insulin aspartDRUG

A single dose administrated subcutaneously (s.c., under the skin) on four separate dosing visits in random order with a washout of 1-2 weeks in-between

BIAsp 30BIAsp 50BIAsp 70IAsp

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Type 1 diabetes for at least 12 months
  • Serum C-peptide maximum 0.4 ng/mL
  • Current basal bolus treatment with soluble human insulin, insulin lispro, insulin glulisine, NPH insulin, insulin detemir or insulin glargine
  • BMI (Body Mass Index) maximum 32 kg/m\^2
  • HbA1c (glycosylated haemoglobin) maximum 9% based on analysis from central laboratory
  • Non-smoker

You may not qualify if:

  • The receipt of any investigational drug within the last 30 days prior to this trial
  • Total daily insulin dose at least 1.8 U/kg/day
  • Current treatment with IAsp (insulin aspart) products
  • A history of drug or alcohol abuse within the last 5 years
  • Impaired hepatic function
  • Impaired renal function
  • Cardiac problems
  • Severe, uncontrolled hypertension

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novo Nordisk Investigational Site

Neuss, 41460, Germany

Location

Related Publications (1)

  • Heise T, Eckers U, Kanc K, Nielsen JN, Nosek L. The pharmacokinetic and pharmacodynamic properties of different formulations of biphasic insulin aspart: a randomized, glucose clamp, crossover study. Diabetes Technol Ther. 2008 Dec;10(6):479-85. doi: 10.1089/dia.2008.0019.

    PMID: 19049377RESULT

Related Links

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 1

Interventions

insulin aspart, insulin aspart protamine drug combination 30:70Insulin Aspart

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune 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

February 15, 2012

First Posted

February 20, 2012

Study Start

April 1, 2006

Primary Completion

July 1, 2006

Study Completion

July 1, 2006

Last Updated

January 6, 2017

Record last verified: 2017-01

Locations

DE(1)