Completed

A Randomised, Double-blind 2 Way Crossover Trial to Investigate the Pharmacokinetics and Pharmacodynamics of Insulin X14 30/70 PreMix Compared to Human Insulin 30/70 PreMix in Healthy Volunteers

What is being tested

biphasic insulin aspart 30

+ biphasic human insulin 30

+ biphasic insulin aspart 30

Drug

Who is being recruted

Endocrine System Diseases+2

+ Metabolic Diseases

+ Nutritional and Metabolic Diseases

From 18 to 50 Years

+4 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 1

Interventional

Study Start: November 1995

See protocol details

Summary

Principal SponsorNovo Nordisk A/S

Last updated: January 4, 2017

Sourced from a government-validated database.Claim as a partner

Study start date: November 1, 1995

Actual date on which the first participant was enrolled.

This trial is conducted in Europe. The aim of this trial is to investigate the pharmacokinetics and pharmacodynamics of insulin X14 30/70 PreMix compared to human insulin 30/70 PreMix in healthy volunteers.

NCT01707160

Principal SponsorNovo Nordisk A/S

Last updated: January 4, 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 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

4 inclusion criteria required to participate

BMI (body mass index) maximum 27 kg/m^2

FBG (fasting blood glucose) maximum 6.0 mmol/L

HbA1c (glycosylated haemoglobin A1c): 3.4-6.1%

Non-smokers

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

Experimental

Group II

Active Comparator

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

Leeds, United KingdomOpen Novo Nordisk Investigational Site in Google Maps

CompletedOne Study Center