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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: December 28, 2011
Last verified: December 2011

December 21, 2011
December 28, 2011
November 2005
February 2006   (final data collection date for primary outcome measure)
  • Area under the serum insulin detemir concentration curve [ Designated as safety issue: No ]
  • Maximum serum insulin concentration [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01498926 on ClinicalTrials.gov Archive Site
  • Area under the glucose infusion rate curve [ Designated as safety issue: No ]
  • Time to maximum serum insulin concentration [ Designated as safety issue: No ]
  • Terminal serum insulin half life [ Designated as safety issue: No ]
  • Area under the serum insulin detemir concentration curve [ Designated as safety issue: No ]
  • Maximum glucose infusion rate [ Designated as safety issue: No ]
  • Time to maximum glucose infusion rate [ Designated as safety issue: No ]
  • Adverse events [ Designated as safety issue: No ]
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
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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
Both
18 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01498926
NN304-1685, 2005-002481-11
No
Public Access to Clinical Trials, Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Birgitte B. Damholt Novo Nordisk A/S
Novo Nordisk A/S
December 2011

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