Comparison of Human Insulin Produced by the Current Process and the NN729 Process in Healthy Volunteers

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Healthy; Diabetes

Treatments: Drug: human insulin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01448070

NN729-1511

Details and patient eligibility

About

This trial is conducted in Europe. The aim of this trial is to show that the product of the new production process has a similar pharmacological profile to the traditional process used for the current commercial product Actrapid®.

Enrollment: 28 patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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 1 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

NN729 manufacturing process

Experimental group

Treatment:

Drug: human insulin

Current manufacturing process

Active Comparator group

Treatment:

Drug: human insulin