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Comparison of Two Insulin Detemir Formulations in Healthy Volunteers

This study has been completed.
Information provided by:
Novo Nordisk A/S Identifier:
First received: December 21, 2011
Last updated: January 13, 2015
Last verified: January 2015
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.

Condition Intervention Phase
Diabetes Healthy Drug: insulin detemir Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Area under the serum insulin detemir concentration curve
  • Maximum serum insulin concentration

Secondary Outcome Measures:
  • Area under the glucose infusion rate curve
  • Time to maximum serum insulin concentration
  • Terminal serum insulin half life
  • Area under the serum insulin detemir concentration curve
  • Maximum glucose infusion rate
  • Time to maximum glucose infusion rate
  • Adverse events

Enrollment: 34
Study Start Date: November 2005
Study Completion Date: February 2006
Primary Completion Date: February 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Glycerol Drug: insulin detemir
Single dose containing glycerol as isotonic agent. Administered subcutaneously (s.c., under the skin)
Active Comparator: Mannitol Drug: insulin detemir
Single dose containing mannitol as isotonic agent. Administered subcutaneously (s.c., under the skin)


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01498926

United Kingdom
Manchester, United Kingdom, M15 6SH
Sponsors and Collaborators
Novo Nordisk A/S
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information: Identifier: NCT01498926     History of Changes
Other Study ID Numbers: NN304-1685
2005-002481-11 ( EudraCT Number )
Study First Received: December 21, 2011
Last Updated: January 13, 2015

Additional relevant MeSH terms:
Insulin, Globin Zinc
Insulin Detemir
Hypoglycemic Agents
Physiological Effects of Drugs
Diuretics, Osmotic
Natriuretic Agents
Cryoprotective Agents
Protective Agents processed this record on August 21, 2017