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Comparison of Insulin Detemir Produced by the Current Process and the NN729 Process in Healthy Subjects

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01490099
First received: December 6, 2011
Last updated: December 8, 2011
Last verified: December 2011
History of Changes
  Purpose

This trial is conducted in Europe. The aim of this trial is to demonstrate bioequivalence between insulin detemir produced by the NN729 process and by the current process in healthy subjects.


Condition Intervention Phase
Diabetes
Healthy
 Drug: insulin detemir
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomised, Single Centre, Double-blind, Two-period Cross-over Glucose Clamp Trial to Demonstrate Bioequivalence Between Insulin Detemir Produced by the NN729 Process and Insulin Detemir Produced by the Current Process in Healthy Subjects

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:
  • AUC0-36h, area under the serum insulin detemir concentration curve [ Time Frame: From 0 to 36 hours ] [ Designated as safety issue: No ]
  • Cmax, maximum serum insulin detemir concentration [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • AUC, area under the serum insulin detemir concentration curve [ Designated as safety issue: No ]
  • Time to maximum concentration (tmax) [ Designated as safety issue: No ]
  • Terminal half life (t½) [ Designated as safety issue: No ]
  • Area under the Curve Glucose Infusion Rate (AUCGIR) [ Designated as safety issue: No ]
  • Adverse events [ Designated as safety issue: No ]

Enrollment: 37
Study Start Date: August 2006
Study Completion Date: November 2006
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment period 1 Drug: insulin detemir
One single dose of insulin detemir produced by current process and the NN729 process injected subcutaneously on two separate dosing visits in varying order
Active Comparator: Treatment period 2 Drug: insulin detemir
One single dose of insulin detemir produced by current process and the NN729 process injected subcutaneously on two separate dosing visits in varying order

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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 18.0 and 27.0 kg/m^2, inclusive
  • Non-smoker
  • Fasting plasma glucose (FPG) maximum 6.0 mmol/L

Exclusion Criteria:

  • Known or suspected allergy to trial products or related products
  • 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)
  • A history of alcohol or drug abuse
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01490099

Locations
United Kingdom
Manchester, United Kingdom, M15 6SH
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Lisbeth V. Jacobsen, MSc. Novo Nordisk
  More Information

Additional Information:
Clinical Trials at Novo Nordisk  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01490099     History of Changes
Other Study ID Numbers: EX1729-1784, 2006-001677-17
Study First Received: December 6, 2011
Last Updated: December 8, 2011
Health Authority: United Kingdom: Medicines and Healthcare Regulatory Authority (MHRA)

Additional relevant MeSH terms:
Insulin
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013