Completed

A Single Centre, Randomized, Balanced Double-blind, Cross-Over Trial Investigating the Bioequivalence of a Continuous Subcutaneous Infusion of a Marketed NovoRapid Formulation Containing 100 U/ml and a New NovoRapid Formulation Containing 200 U/ml in Healthy Male Volunteers

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

insulin aspart

+ insulin aspart

Drug
Who is being recruted

Endocrine System Diseases+2

+ Metabolic Diseases

+ Nutritional and Metabolic Diseases

From 18 to 50 Years
+8 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: September 2002
See protocol details

Summary

Principal SponsorNovo Nordisk A/S
Last updated: March 1, 2017
Sourced from a government-validated database.Claim as a partner

Study start date: September 2, 2002

Actual date on which the first participant was enrolled.

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).

NCT01698697
Principal SponsorNovo Nordisk A/S
Last updated: March 1, 2017
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

24 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Male

Biological sex of participants that are eligible to enroll.

From 18 to 50 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Endocrine System DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesGlucose Metabolism DisordersDiabetes Mellitus

Criteria

5 inclusion criteria required to participate
Body mass index (BMI) 18-26 kg/m^2 (both inclusive)
Non-smoker
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
Show More Criteria
3 exclusion criteria prevent from participating
Any condition requiring the regular use of any medication
Family history of type 1 diabetes mellitus
Known or suspected allergy to the trial product or related products

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator

Group II

Experimental

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Novo Nordisk Investigational Site

Bloemfontein, South AfricaOpen Novo Nordisk Investigational Site in Google Maps
CompletedOne Study Center