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NCT01707160 Clinical Trial

Pharmacokinetics and Pharmacodynamics of Biphasic Insulin Aspart 30 in Healthy Volunteers

Healthy Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01707160
Other study ID # ANA/DCD/031
Secondary ID
Status Completed
Phase Phase 1
First received October 10, 2012
Last updated January 3, 2017
Start date November 1995
Est. completion date December 1995

Study information
Verified date January 2017
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Medicines and Healthcare Products Regulatory Agency
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 24
Est. completion date December 1995
Est. primary completion date December 1995
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria:

- Non-smokers

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

- HbA1c (glycosylated haemoglobin A1c): 3.4-6.1%

- FBG (fasting blood glucose) maximum 6.0 mmol/L

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• biphasic insulin aspart 30
One single dose of each trial drug separated by 4-10 days injected subcutaneously (s.c, under the skin) in random order
• biphasic human insulin 30
One single dose of each trial drug separated by 4-10 days injected subcutaneously (s.c, under the skin) in random order

Locations
Country Name City State
United Kingdom Novo Nordisk Investigational Site Leeds

Sponsors (1)
Lead Sponsor Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

Jacobsen LV, Søgaard B, Riis A. Pharmacokinetics and pharmacodynamics of a premixed formulation of soluble and protamine-retarded insulin aspart. Eur J Clin Pharmacol. 2000 Aug;56(5):399-403. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Area under the Curve No
Secondary Maximum insulin concentration (Cmax) No
Secondary Time to maximum insulin concentration (tmax) No
Secondary Minimum glucose concentration (Cmin(glu)) No
Secondary Time to minimum glucose concentration (tmin(glu)) No
Secondary Adverse events No
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