Status:

COMPLETED

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

Lead Sponsor:

Novo Nordisk A/S

Conditions:

Diabetes

Healthy

Eligibility:

MALE

18-50 years

Phase:

PHASE1

Brief Summary

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...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

October 15 2002

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 20 2002

Estimated Enrollment :

28 Patients enrolled

Trial Details

Trial ID

NCT01448070

Start Date

October 15 2002

End Date

December 20 2002

Last Update

February 27 2017

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Novo Nordisk Investigational Site

Manchester, United Kingdom, M15 6SH