- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01486901
Bioequivalence of Two Insulatard® Formulations in Healthy Subjects
April 27, 2015 updated by: Novo Nordisk A/S
A Randomised, Single Centre, Double-blind, Two-period Cross-over, Glucose Clamp Trial to Test for Bioequivalence Between Insulatard® (600 Nmol/ml) and Insulatard® (1998 Nmol/ml) in Healthy Subjects
This trial is conducted in Europe.
The aim of this trial is to test for bioequivalence between two formulations of Insulatard® in healthy subjects.
Study Overview
Study Type
Interventional
Enrollment (Actual)
44
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
-
-
-
Neuss, Germany, 41460
-
-
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 18.0 and 27.0 kg/m^2, inclusive
- Non-smoker, defined as no nicotine consumption for at least one year
- Fasting plasma glucose below or equal to 100 mg/dL (5.6 mmol/L)
Exclusion Criteria:
- Previous participation in this trial or other clinical trials within the last 3 months
- Body weight above 87.5 kg
- 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, or sterilisation, or the oral contraceptive pill, which should have been taken without difficulty for at least 3 months, an approved hormonal implant)
- History of alcohol or drug abuse
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 |
---|---|
Experimental: Formulation A
|
Single dose of each formulation, administered subcutaneously (s.c., under the skin) on two separate dosing visits
|
Active Comparator: Formulation B
|
Single dose of each formulation, administered subcutaneously (s.c., under the skin) on two separate dosing visits
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Area under the serum insulin concentration-time curve (AUC 0-24 hours)
|
Maximum serum insulin concentration (Cmax)
|
Secondary Outcome Measures
Outcome Measure |
---|
Adverse events
|
Area under the serum insulin concentration-time curve (AUC 0-inifinity hours)
|
Time to maximum serum insulin concentration (tmax)
|
Terminal serum insulin half life (t½)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
May 1, 2006
Primary Completion (Actual)
July 1, 2006
Study Completion (Actual)
July 1, 2006
Study Registration Dates
First Submitted
December 5, 2011
First Submitted That Met QC Criteria
December 5, 2011
First Posted (Estimate)
December 7, 2011
Study Record Updates
Last Update Posted (Estimate)
April 28, 2015
Last Update Submitted That Met QC Criteria
April 27, 2015
Last Verified
April 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EX1000-1736
- 2005-006049-18 (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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