- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01865318
Investigation of Pharmacodynamic Characteristics of Explorative Formulation of Insulin Degludec in Male Subjects With Type 1 Diabetes
October 21, 2015 updated by: Novo Nordisk A/S
A Single Centre, Open-Label, Multiple Dose Trial Examining the Pharmacodynamic Characteristics of Insulin 454 Under Single-Dose and Steady-State Conditions in Male Subjects With Type 1 Diabetes
This trial is conducted in Europe.
The aim of this trial is to investigate the pharmacodynamic (the effect of the investigated drug on the body) of insulin degludec (insulin 454), an explorative formulation, not similar to the proposed commercial formulation, under single-dose and steady-state conditions in male subjects with type 1 diabetes.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
36
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
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Neuss, Germany, 41460
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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 69 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Male and are considered to be generally healthy, except for the underlying diabetes mellitus, based on an assessment of medical history, physical examination and clinical laboratory data, as judged by the Investigator
- Diagnosed with type 1 diabetes mellitus and treated with insulin for at least 12 months
- Body Mass Index (BMI) between 18.0 and 27.0 kg/m^2 (both inclusive)
- Glycosylated haemoglobin A1c (HbA1c) below or equal to 10.0 % based on central laboratory results
Exclusion Criteria:
- History of significant multiple drug allergies or with a known or suspected allergy to the trial product or any medicine chemically related to the trial product, as judged by the Investigator
- Participation in any other trials involving investigational products within 3 months preceding the start of dosing
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: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Part 1 (Once-daily dosing regimen, high concentration)
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Administered subcutaneously (s.c., under the skin)
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Experimental: Part 2 (Twice-daily dosing regimen, high concentration)
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Administered subcutaneously (s.c., under the skin)
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Experimental: Part 3 (Once-daily dosing regimen, low concentration)
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Administered subcutaneously (s.c., under the skin)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Area under the glucose infusion rate curve
Time Frame: 0-24 hours after dosing
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0-24 hours after dosing
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Maximum glucose infusion rate (GIRmax)
Time Frame: 0-24 hours after dosing
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0-24 hours after dosing
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Time to maximum glucose infusion rate (tGIRmax)
Time Frame: 0-24 hours after dosing
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0-24 hours after dosing
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Area under the serum insulin degludec curve
Time Frame: 0-96 hours after dosing
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0-96 hours after dosing
|
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
September 1, 2006
Primary Completion (Actual)
January 1, 2007
Study Completion (Actual)
January 1, 2007
Study Registration Dates
First Submitted
May 27, 2013
First Submitted That Met QC Criteria
May 27, 2013
First Posted (Estimate)
May 30, 2013
Study Record Updates
Last Update Posted (Estimate)
October 22, 2015
Last Update Submitted That Met QC Criteria
October 21, 2015
Last Verified
October 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NN5401-1740
- 2006-002212-97 (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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Clinical Trials on insulin degludec
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Novo Nordisk A/SCompletedDiabetes | Diabetes Mellitus, Type 1Germany
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Novo Nordisk A/SCompleted
-
Novo Nordisk A/SCompletedDiabetes | Diabetes Mellitus, Type 1Austria
-
Novo Nordisk A/SCompletedDiabetes Mellitus, Type 2 | DiabetesUnited States, France, Austria, Norway, Algeria
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Novo Nordisk A/SCompletedDiabetes | Diabetes Mellitus, Type 1Germany
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Novo Nordisk A/SCompletedDiabetes | Diabetes Mellitus, Type 1Germany
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Novo Nordisk A/SCompletedDiabetes Mellitus, Type 2 | Diabetes | Diabetes Mellitus, Type 1Germany
-
Novo Nordisk A/SCompletedDiabetes Mellitus, Type 2 | DiabetesUnited States, Malaysia, Germany, Algeria, Turkey
-
Novo Nordisk A/SCompletedDiabetes Mellitus, Type 2United States, Mexico, Puerto Rico, Canada, Denmark, France, Austria, Taiwan, Czechia, Brazil, China, Argentina
-
Sunshine Lake Pharma Co., Ltd.Not yet recruiting