Comparison of Two Insulin Aspart Formulations in Healthy Volunteers

NCT ID: NCT01698697

Last Updated: 2017-03-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-09-02
• Study Completion Date: 2002-10-18

Brief Summary

This trial is conducted in Africa. The aim of this trial is to determine if a new formulation (U200) of insulin aspart containing 200 U/mL is bioequivalent to that of a marketed insulin aspart formulation (U100).

Conditions

Diabetes; Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

U100

Group Type: ACTIVE_COMPARATOR

insulin aspart

Intervention Type: DRUG

Bolus 0.1 U/kg administered simultaneously with a continuous infusion of 0.029 U/kg/h via a programmed insulin pump. A total dose of 0.35 U/kg is delivered to the subject in the 12 hour infusion

U200

Group Type: EXPERIMENTAL

insulin aspart

Intervention Type: DRUG

Bolus 0.1 U/kg administered simultaneously with a continuous infusion of 0.029 U/kg/h via a programmed insulin pump. A total dose of 0.35 U/kg is delivered to the subject in the 12 hour infusion

Interventions

insulin aspart

Bolus 0.1 U/kg administered simultaneously with a continuous infusion of 0.029 U/kg/h via a programmed insulin pump. A total dose of 0.35 U/kg is delivered to the subject in the 12 hour infusion

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Normal findings in medical history and physical examination unless the investigator considers any abnormality to be clinically irrelevant
• Normal laboratory values, electrocardiogram (ECG), and vital signs unless the investigator considers any abnormality to be clinically irrelevant
• Body mass index (BMI) 18-26 kg/m^2 (both inclusive)
• Weight 60-90 kg
• Non-smoker

Exclusion Criteria

• Any condition requiring the regular use of any medication
• Known or suspected allergy to the trial product or related products
• Family history of type 1 diabetes mellitus

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Novo Nordisk A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Global Clinical Registry (GCR, 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

Novo Nordisk Investigational Site

Bloemfontein, , South Africa

Countries

South Africa

Related Links

http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

NN248-1494

Identifier Type: -

Identifier Source: org_study_id