NCT01520831

Brief Summary

This trial is conducted in Europe. The aim of this trial is to demonstrate a difference between the pharmacodynamics and pharmacokinetics of biphasic insulin aspart 30, biphasic insulin aspart 50, biphasic insulin aspart 70 and insulin aspart in healthy subjects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P50-P75 for phase_1 diabetes

Timeline
Completed

Started Apr 1999

Longer than P75 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, 1999

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2000

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2000

Completed
11.7 years until next milestone

First Submitted

Initial submission to the registry

January 25, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 30, 2012

Completed
Last Updated

January 4, 2017

Status Verified

January 1, 2017

Enrollment Period

1.1 years

First QC Date

January 25, 2012

Last Update Submit

January 3, 2017

Conditions

DiabetesHealthy

Outcome Measures

Primary Outcomes (1)

  • Area under the GIR (Glucose Infusion Rate) profile (AUC GIR) in the interval 0-120 minutes

Secondary Outcomes (7)

  • Maximum GIR value

  • Time to maximum GIR value

  • Area under the GIR profile

  • Cmax, maximum insulin aspart concentration

  • Area under the insulin aspart concentration curve

  • +2 more secondary outcomes

Study Arms (4)

BIAsp 30

EXPERIMENTAL
Drug: biphasic insulin aspart 30

BIAsp 50

EXPERIMENTAL
Drug: biphasic insulin aspart 50

BIAsp 70

EXPERIMENTAL
Drug: biphasic insulin aspart 70

Insulin aspart

ACTIVE COMPARATOR
Drug: insulin aspart

Interventions

biphasic insulin aspart 30DRUG

One single dose of 0.3 U/kg body weight administered subcutaneously (s.c., under the skin) at one of four study days

BIAsp 30
biphasic insulin aspart 50DRUG

One single dose of 0.3 U/kg body weight administered subcutaneously (s.c., under the skin) at one of four study days

BIAsp 50
biphasic insulin aspart 70DRUG

One single dose of 0.3 U/kg body weight administered subcutaneously (s.c., under the skin) at one of four study days

BIAsp 70
insulin aspartDRUG

One single dose of 0.3 U/kg body weight administered subcutaneously (s.c., under the skin) at one of four study days

Insulin aspart

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Body mass index between 18 and 28 kg/m\^2 inclusive
  • HbA1c within the normal laboratory range
  • Non smoker for at least three months
  • Females of childbearing potential using acceptable methods of contraception, including tubal ligation, an intrauterine device (IUD) , the oral contraceptive pill or barrier methods

You may not qualify if:

  • Subjects who have received any investigational drug in the 3 months prior to the start of dosing
  • Any disease requiring regular use of non topical prescription medicines
  • Any serious systemic infectious disease that occurred in the 4 weeks prior to the first dose of test drug
  • Any intercurrent illness or endocrine disorders that may affect blood glucose
  • Subject with a history of drug or alcohol dependence
  • Subject with a first degree relative with diabetes mellitus
  • Subject with a history of clinically relevant allergic reactions to medical products
  • Subjects who have donated any blood or plasma in the past 3 month preceding screening

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, Kapitza C, Jacobsen LV, Brøndsted L, Heinemann L. Pharmacokinetic and pharmacodynamic differences between premixed suspensions of insulin aspart: biphasic insulin aspart 30, 50 and 70. Diabetologia 2005; 48 (Suppl. 1): A301

    RESULT

Related Links

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

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

January 25, 2012

First Posted

January 30, 2012

Study Start

April 1, 1999

Primary Completion

May 1, 2000

Study Completion

May 1, 2000

Last Updated

January 4, 2017

Record last verified: 2017-01

Locations

DE(1)