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OpenTrials
Completed

NCT Number: NCT01448070

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

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®.

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Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Healthy Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Novo Nordisk Investigational Site

Manchester, M15 6SH, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

human insulin

Drug

Single dose of 0.2 IU/kg, administered subcutaneously (under the skin)

Primary outcomes

  1. AUC (area under the curve) 0-8h (human insulin)

  2. Cmax (maximum plasma concentration)

  3. Area under the curve (glucose infusion rate (GIR)), 0-8h

Secondary outcomes

  1. tmax (time to reach maximum)

  2. t½ (terminal half-life)

  3. GIR (glucose infusion rate) max

  4. tGIR (glucose infusion rate) max

  5. Area under the curve (C-peptide, 0-8h)

  6. Physical examinations and vital signs

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

A Single Centre, Randomized, Balanced Double Blind, Cross-over Trial Investigating the Bioequivalence of Actrapid® Produced by the Current Process and Human Insulin With the Same Formulation as Actrapid®, Produced by the NN729 Process

Important dates

Study start
2002
Primary completion
2002
Study completion
2002
First posted
Oct 7, 2011
Registry last updated
Feb 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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