Comparison of Two Insulin Detemir Formulations in Healthy Volunteers

January 13, 2015 updated by: Novo Nordisk A/S

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Mannitol
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
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Area under the serum insulin detemir concentration curve
Maximum serum insulin concentration

Secondary Outcome Measures

Outcome Measure
Adverse events
Area under the serum insulin detemir concentration curve
Area under the glucose infusion rate curve
Time to maximum serum insulin concentration
Terminal serum insulin half life
Maximum glucose infusion rate
Time to maximum glucose infusion rate

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2005

Primary Completion (Actual)

February 1, 2006

Study Completion (Actual)

February 1, 2006

Study Registration Dates

First Submitted

December 21, 2011

First Submitted That Met QC Criteria

December 21, 2011

First Posted (Estimate)

December 26, 2011

Study Record Updates

Last Update Posted (Estimate)

January 14, 2015

Last Update Submitted That Met QC Criteria

January 13, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN304-1685
  • 2005-002481-11 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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