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

Phase 1

Completed

• Conditions: Diabetes; Healthy
• Interventions: Drug: biphasic insulin aspart 70

• Registration Number: NCT01527565
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2003-01-20
• Primary Completion: 2003-02-26
• Study Completion: 2003-02-26
• Study First Submitted: 2012-02-02
• Study First Submitted QC: 2012-02-02
• Study First Posted: 2012-02-07
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-22
• Last Update Posted: 2017-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 30

Inclusion Criteria

• Considered generally healthy upon completion of medical history and physical
• examination, as judged by the investigator
• Body Mass Index (BMI) between 19-29 kg/m^2 (both inclusive)
• Minimum body weight of 65 kg
• Fasting blood glucose between 3.8-6.0 mmol/L
• Glycohemoglobin (HbA1c) below 6.4 %
• Non-smokers

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Exclusion Criteria

• Clinically significant abnormal hematology, biochemistry, urinalysis or ECG (electrocardiogram) screening tests, as judged by the investigator
• A history of any illness that, in the opinion of the Investigator and/or Sponsor, might confound the results of the study 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 drug/alcohol abuse screen)
• Hepatitis B or C
• Subjects with a first-degree relative with diabetes mellitus
• Known or suspected allergy to trial product or related products
• Smoking during the past three months

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Formulation A	biphasic insulin aspart 70	-
Formulation B	biphasic insulin aspart 70	-

Primary Outcome Measures

Name	Time	Method
Area under the insulin aspart curve in the interval from 0-16 hours
Cmax, maximum insulin aspart concentration

Secondary Outcome Measures

Name	Time	Method
tmax, the time to maximum insulin aspart concentration
Area under the insulin aspart curve
Mean residence time (MRT)
The area under the glucose infusion rate curve
GIRmax, maximum glucose infusion rate value
tGIRmax, time to maximum glucose infusion rate value
Adverse events

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇿🇦 Bloemfontein, South Africa