Comparison of Insulin Aspart Produced by Current Process and the NN2000 Process

Phase 1

Completed

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

• Registration Number: NCT01486914
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This trial is conducted in Europe. The aim of this trial is to compare insulin aspart produced by current process and the NN2000 process.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-01-19
• Primary Completion: 2003-02-24
• Study Completion: 2003-02-24
• Study First Submitted: 2011-12-05
• Study First Submitted QC: 2011-12-05
• Study First Posted: 2011-12-07
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-28
• Last Update Posted: 2017-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 28

Inclusion Criteria

• Healthy
• Caucasian
• Normal findings in medical history and physical examination unless the investigator considers any abnormality to be clinically irrelevant
• Fasting blood glucose below or equal to 6 mmol/L
• Body mass index (BMI) 22.0-27.0 kg/m^2 (both inclusive)

Exclusion Criteria

• Participated in another clinical study with an investigational drug within the last 4 weeks
• Any condition requiring the regular use of any medication, including herbal remedies, over the counter medicines and vitamins. Occasional paracetamol is acceptable
• Known or suspected allergy to the trial product or related products
• Family history of type 2 diabetes

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
NN2000	insulin aspart	-
IAsp	insulin aspart	-

Primary Outcome Measures

Name	Time	Method
Area under the Curve (AUC) (insulin aspart)

Secondary Outcome Measures

Name	Time	Method
Terminal half life (t½)
Cmax (maximum plasma concentration)
Adverse events
Incident of hypoglycaemic episodes

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇬🇧 Manchester, United Kingdom