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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:
ClinicalTrials.gov Identifier:
NCT01490099
First Posted: December 12, 2011
Last Update Posted: February 8, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
  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
Intervention Model: Crossover Assignment
Masking: Double (Participant, 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:


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

Primary Outcome Measures:
  • AUC0-36h, area under the serum insulin detemir concentration curve [ Time Frame: From 0 to 36 hours ]
  • Cmax, maximum serum insulin detemir concentration

Secondary Outcome Measures:
  • AUC, area under the serum insulin detemir concentration curve
  • Time to maximum concentration (tmax)
  • Terminal half life (t½)
  • Area under the Curve Glucose Infusion Rate (AUCGIR)
  • Adverse events

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

Information from the National Library of Medicine

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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 18.0 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
Information from the National Library of Medicine

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): NCT01490099


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

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01490099     History of Changes
Other Study ID Numbers: EX1729-1784
2006-001677-17 ( EudraCT Number )
First Submitted: December 6, 2011
First Posted: December 12, 2011
Last Update Posted: February 8, 2016
Last Verified: February 2016

Additional relevant MeSH terms:
Insulin, Globin Zinc
Insulin
Insulin Detemir
Hypoglycemic Agents
Physiological Effects of Drugs