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Comparison of Two Insulin Detemir Formulations in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01498926
First received: December 21, 2011
Last updated: January 13, 2015
Last verified: January 2015
December 21, 2011
January 13, 2015
November 2005
February 2006   (Final data collection date for primary outcome measure)
  • Area under the serum insulin detemir concentration curve
  • Maximum serum insulin concentration
Same as current
Complete list of historical versions of study NCT01498926 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Comparison of Two Insulin Detemir Formulations in Healthy Volunteers
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
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
  • Diabetes
  • Healthy
  • Drug: insulin detemir
    Single dose containing mannitol as isotonic agent. Administered subcutaneously (s.c., under the skin)
  • Drug: insulin detemir
    Single dose containing glycerol as isotonic agent. Administered subcutaneously (s.c., under the skin)
  • Experimental: Glycerol
    Intervention: Drug: insulin detemir
  • Active Comparator: Mannitol
    Intervention: Drug: insulin detemir
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
34
February 2006
February 2006   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
 
NCT01498926
NN304-1685
2005-002481-11 ( EudraCT Number )
No
Not Provided
Not Provided
Not Provided
Novo Nordisk A/S
Not Provided
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Novo Nordisk A/S
January 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP