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Completed

NCT Number: NCT01490099

Comparison of Insulin Detemir Produced by the Current Process and the NN729 Process in Healthy Subjects

This trial is conducted in Europe. The aim of this trial is to demonstrate bioequivalence between insulin detemir produced by the NN729 process and by the current process in healthy subjects.

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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–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Manchester, M15 6SH, United Kingdom

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Considered generally healthy upon completion of medical history and physical examination as judged by the Investigator
  • Body mass index (BMI) between 18.0 and 27.0 kg/m^2, inclusive
  • Non-smoker
  • Fasting plasma glucose (FPG) maximum 6.0 mmol/L

Exclusion criteria

  • Known or suspected allergy to trial products or related products
  • Pregnant, breast-feeding or the intention of becoming pregnant or not using adequate contraceptive measures (intrauterine device (IUD) that has been in place for at least 3 months, sterilisation, the oral contraceptive pill (which should have been taken without difficulty for at least 3 months) or an approved hormonal implant)
  • A history of alcohol or drug abuse

Treatment and study plan

insulin detemir

Drug

One single dose of insulin detemir produced by current process and the NN729 process injected subcutaneously on two separate dosing visits in varying order

Primary outcomes

  1. AUC0-36h, area under the serum insulin detemir concentration curve

    Time frame: From 0 to 36 hours

  2. Cmax, maximum serum insulin detemir concentration

Secondary outcomes

  1. AUC, area under the serum insulin detemir concentration curve

  2. Time to maximum concentration (tmax)

  3. Terminal half life (t½)

  4. Area under the Curve Glucose Infusion Rate (AUCGIR)

  5. Adverse events

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

A Randomised, Single Centre, Double-blind, Two-period Cross-over Glucose Clamp Trial to Demonstrate Bioequivalence Between Insulin Detemir Produced by the NN729 Process and Insulin Detemir Produced by the Current Process in Healthy Subjects

Important dates

Study start
2006
Primary completion
2006
Study completion
2006
First posted
Dec 12, 2011
Registry last updated
Feb 8, 2016

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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