Bioequivalence of Two Formulations of Biphasic Insulin Aspart 70 in Healthy Subjects

Healthy Clinical Trial

Official title:

Single-Centre, Randomised, Balanced, Double-Blind, Cross-Over Trial Investigating the Bioequivalence of Formulation 2 and Formulation 4 of Biphasic Insulin Aspart 70 in Healthy Male Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01527656
• Other study ID #: BIASP-1577
• Status: Completed
• Phase: Phase 1
• First received: February 2, 2012
• Last updated: January 5, 2017
• Start date: December 2003
• Est. completion date: February 2004

Study information

• Verified date: January 2017
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

This trial is conducted in Europe. The aim of this trial is to investigate the bioequivalence of two formulations of biphasic insulin aspart 70 in healthy male subjects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 2004
• Est. primary completion date: February 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Considered generally healthy upon completion of medical history and physical examination, as judged by the investigator

• Body Mass Index (BMI) between 19.0-30.0 kg/m^2

• Glycohemoglobin (HbA1c) within laboratory normal range

• Non-smokers

Exclusion Criteria:

• Clinically significant abnormal haematology, biochemistry, urinalysis or ECG (electrocardiogram) screening tests, as judged by the investigator

• Liver enzyme values (ALAT and ASAT) exceeding 2 times the upper reference limit according to the local laboratory

• A history of any illness that, in the opinion of the Investigator and/or Sponsor, might confound the results of the trial or pose additional risk in administering the investigational product to the subject

• History of or current addiction to alcohol or drugs of abuse as determined by the investigator (positive urine drug screen and breath alcohol screen)

• HIV (human immunodeficiency virus), Hepatitis B or C positive

• Subjects with a first-degree relative with diabetes mellitus

• A history of multiple and/or severe allergies to drugs or foods or a history of anaphylactic reactions

• Known or suspected allergy to trial product or related products

• Smoking during the past three months

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes
• Healthy

Intervention

Drug:
• biphasic insulin aspart 70
A single dose administrated subcutaneously (s.c., under the skin) on two separate dosing visits. A wash-out period of 6-12 days will take place between dosing visits

Locations

Country	Name	City	State
Germany	Novo Nordisk Investigational Site	Neuss

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Hanefeld M, Fischer S, Julius U, Schulze J, Schwanebeck U, Schmechel H, Ziegelasch HJ, Lindner J. Risk factors for myocardial infarction and death in newly detected NIDDM: the Diabetes Intervention Study, 11-year follow-up. Diabetologia. 1996 Dec;39(12):1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the insulin aspart curve in the interval from 0-16 hours			No
Primary	Cmax, maximum insulin aspart concentration			No
Secondary	tmax, time to maximum insulin aspart concentration			No
Secondary	Area under the insulin aspart curve			No
Secondary	Mean residence time (MRT)			No
Secondary	t½, terminal half-life			No
Secondary	Incidence of hypoglycaemic events			No

External Links

•   Clinical Trials at Novo Nordisk