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

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Healthy; Diabetes

Treatments: Drug: insulin aspart

Study type: Interventional

Funder types: Industry

Identifiers

NCT01486914

NN2000-1512

Details and patient eligibility

About

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

Enrollment: 28 patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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28 participants in 2 patient groups

NN2000

Experimental group

Treatment:

Drug: insulin aspart

IAsp

Active Comparator group

Treatment:

Drug: insulin aspart