Bioequivalence of Two Insulin Aspart Formulations (100 U/mL Versus 200 U/mL)

Phase 1

Completed

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

• Registration Number: NCT01530048
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This trial is conducted in Europe. The aim of this trial is to test if there is bioequivalence between the insulin aspart 100 U/mL (U100) formulation and the new insulin aspart 200 U/mL (U200) formulation.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-03
• Primary Completion: 2006-05
• Study Completion: 2006-05
• Study First Submitted: 2012-02-07
• Study First Submitted QC: 2012-02-07
• Study First Posted: 2012-02-09
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-14
• Last Update Posted: 2016-10-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

• Considered to be healthy as judged from vital signs, medical history, ECG (electrocardiogram), laboratory values, and physical examination
• Body mass index between 18 and 27 kg/m^2 (both inclusive)
• Non-smoker
• Fasting blood glucose maximum 6 mmol/L
• HbA1c below 6.4%

Exclusion Criteria

• Pregnant or breast-feeding women
• Women not using acceptable methods of contraception without difficulties for at least three months prior to trial start (screening), including intrauterine devices, oral contraceptives, hormonal implants, or sterilisation
• Clinically significant abnormal laboratory values (as judged by the Investigator)
• Close relative with type 1 diabetes mellitus (father, mother, sister or brother)
• Intake of alcohol within the last 24 hours prior to screening and drug administration visits
• Blood donation or blood loss of more than 500 mL within the 3 last months before screening
• Strenuous exercise within 48 hours before screening as well as drug administration and followup
• Smoking during the past month before drug administration

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
U200	insulin aspart	-
U100	insulin aspart	-

Primary Outcome Measures

Name	Time	Method
Cmax, maximum concentration
Area under the curve (AUC) in the interval of 0-6 hours

Secondary Outcome Measures

Name	Time	Method
Vz/f, volume of distribution during terminal phase
GIRmax, maximum glucose infusion rate value
tGIRmax, time to maximum glucose infusion rate value
AUC in the interval of 0-infinity hours
tmax, time to reach Cmax
Terminal rate constant
t½, terminal half-life
AUCGIR, area under the glucose infusion rate value curve
Adverse events

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇩🇰 Hvidovre, Denmark