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Comparison of Two Insulin Detemir Formulations in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT01498926
Recruitment Status : Completed
First Posted : December 26, 2011
Last Update Posted : January 14, 2015
Sponsor:
Information provided by:
Novo Nordisk A/S

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Diabetes Healthy Drug: insulin detemir Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
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
Study Start Date : November 2005
Actual Primary Completion Date : February 2006
Actual Study Completion Date : February 2006

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Arms and Interventions
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Arm Intervention/treatment
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)


Outcome Measures
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Primary Outcome Measures :
  1. Area under the serum insulin detemir concentration curve
  2. Maximum serum insulin concentration

Secondary Outcome Measures :
  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

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

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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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01498926


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

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ClinicalTrials.gov Identifier: NCT01498926    
Other Study ID Numbers: NN304-1685
2005-002481-11 ( EudraCT Number )
First Posted: December 26, 2011    Key Record Dates
Last Update Posted: January 14, 2015
Last Verified: January 2015
Additional relevant MeSH terms:
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Insulin
Insulin, Globin Zinc
Insulin Detemir
Hypoglycemic Agents
Physiological Effects of Drugs