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Comparison of Two Insulin Aspart Formulations in Healthy Volunteers

NCT01698697 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2017-03-01

No results posted yet for this study

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

Interventions

DRUG

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

Sponsors & Collaborators

Principal Investigators

  • Global Clinical Registry (GCR, 1452) · Novo Nordisk A/S

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-09-02
Primary Completion
2002-10-18
Completion
2002-10-18

Countries

  • South Africa

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01698697 on ClinicalTrials.gov