Comparison of Biphasic Insulin Aspart (30, 50 and 70) and Insulin Aspart in Healthy Subjects

Phase 1

Completed

• Conditions: Diabetes; Healthy
• Interventions: Drug: biphasic insulin aspart 30; Drug: biphasic insulin aspart 50; Drug: biphasic insulin aspart 70; Drug: insulin aspart

• Registration Number: NCT01520831
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This trial is conducted in Europe. The aim of this trial is to demonstrate a difference between the pharmacodynamics and pharmacokinetics of biphasic insulin aspart 30, biphasic insulin aspart 50, biphasic insulin aspart 70 and insulin aspart in healthy subjects.

Detailed Description

Not available

Study Timeline

• Study Start: 1999-04
• Primary Completion: 2000-05
• Study Completion: 2000-05
• Study First Submitted: 2012-01-25
• Study First Submitted QC: 2012-01-25
• Study First Posted: 2012-01-30
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-03
• Last Update Posted: 2017-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

• Body mass index between 18 and 28 kg/m^2 inclusive
• HbA1c within the normal laboratory range
• Non smoker for at least three months
• Females of childbearing potential using acceptable methods of contraception, including tubal ligation, an intrauterine device (IUD) , the oral contraceptive pill or barrier methods

Exclusion Criteria

• Subjects who have received any investigational drug in the 3 months prior to the start of dosing
• Any disease requiring regular use of non topical prescription medicines
• Any serious systemic infectious disease that occurred in the 4 weeks prior to the first dose of test drug
• Any intercurrent illness or endocrine disorders that may affect blood glucose
• Subject with a history of drug or alcohol dependence
• Subject with a first degree relative with diabetes mellitus
• Subject with a history of clinically relevant allergic reactions to medical products
• Subjects who have donated any blood or plasma in the past 3 month preceding screening

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
BIAsp 30	biphasic insulin aspart 30	-
BIAsp 50	biphasic insulin aspart 50	-
BIAsp 70	biphasic insulin aspart 70	-
Insulin aspart	insulin aspart	-

Primary Outcome Measures

Name	Time	Method
Area under the GIR (Glucose Infusion Rate) profile (AUC GIR) in the interval 0-120 minutes

Secondary Outcome Measures

Name	Time	Method
t½, terminal half-life
Area under the GIR profile
Maximum GIR value
Time to maximum GIR value
Cmax, maximum insulin aspart concentration
Area under the insulin aspart concentration curve
tmax, the time to maximum insulin aspart concentration

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇩🇪 Neuss, Germany