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Completed

NCT Number: NCT01498926

Comparison of Two Insulin Detemir Formulations in Healthy Volunteers

This trial is conducted in Europe. The aim of this trial is to compare two formulations of insulin detemir containing an isotonic agent in healthy volunteers.

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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 and 27 kg/m^2, inclusive
  • Non-smoker
  • Fasting plasma glucose maximum 6 mmol/L

Exclusion criteria

  • Known or suspected allergy to trial products or related products
  • Previous participation in this trial
  • 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)
  • The receipt of any investigational drug within the last 3 months prior to this trial

Treatment and study plan

insulin detemir

Drug

Single dose containing mannitol as isotonic agent. Administered subcutaneously (s.c., under the skin)

Primary outcomes

  1. Area under the serum insulin detemir concentration curve

  2. Maximum serum insulin concentration

Secondary outcomes

  1. Area under the glucose infusion rate curve

  2. Time to maximum serum insulin concentration

  3. Terminal serum insulin half life

  4. Area under the serum insulin detemir concentration curve

  5. Maximum glucose infusion rate

  6. Time to maximum glucose infusion rate

  7. Adverse events

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

A Randomised, Single Centre, Two-period, Cross-over, Glucose Clamp Trial to Test for Bioequivalence Between Two Insulin Detemir Formulations Containing Mannitol and Glycerol as Isotonic Agents Respectively, in Healthy Subjects

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Dec 26, 2011
Registry last updated
Jan 14, 2015

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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