- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01773798
A Trial Investigating the Pharmacodynamic and Pharmacokinetic Properties of Insulin Degludec/Insulin Aspart 15 in Subjects With Type 1 Diabetes
March 4, 2015 updated by: Novo Nordisk A/S
This trial is conducted in Europe.
The aim of the trial is to investigate the pharmacodynamic (the effect of the investigated drug on the body) and the pharmacokinetic (exposure of the trial drug in the body) properties of insulin degludec/insulin aspart 15 in subjects with type 1 diabetes.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
33
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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Graz, Austria, 8010
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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 64 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months
- Body mass index 18.0-28.0 kg/m^2 (both inclusive)
Exclusion Criteria:
- Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
- Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day)
- Not able or willing to refrain from smoking, use of nicotine substitute products or transdermal nicotine patches during the inpatient period
- Female of childbearing potential who is pregnant, breast-feeding or intend to become pregnant or is not using adequate contraceptive methods (adequate contraceptive measures include sterilisation, hormonal intrauterine devices, oral contraceptives, condom with spermizide, sexual abstinence or vasectomised partner)
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: IDegAsp
|
Each subject subject will be randomly allocated to five single doses.
Administered subcutaneously (s.c, under the skin) on five dosing visits separated by 15-25 days.
Each subject subject will be randomly allocated to five single doses.
Administered subcutaneously (s.c, under the skin) on five dosing visits separated by 15-25 days.
The dose level will be 0.5 U/kg Body Weight (BW).
Other Names:
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Experimental: IDeg
|
Each subject subject will be randomly allocated to five single doses.
Administered subcutaneously (s.c, under the skin) on five dosing visits separated by 15-25 days.
The dose level will be 0.425 U/kg Body Weight (BW).
|
Experimental: IDeg + IAsp
|
Each subject subject will be randomly allocated to five single doses.
Administered subcutaneously (s.c, under the skin) on five dosing visits separated by 15-25 days.
The dose level will be 0.425 U/kg Body Weight (BW).
Each subject subject will be randomly allocated to five single doses.
Administered subcutaneously (s.c, under the skin) on five dosing visits separated by 15-25 days.
The dose level will be 0.075 U/kg Body Weight (BW).
|
Active Comparator: IAsp
|
Each subject subject will be randomly allocated to five single doses.
Administered subcutaneously (s.c, under the skin) on five dosing visits separated by 15-25 days.
The dose level will be 0.075 U/kg Body Weight (BW).
|
Experimental: IDegAsp 15
|
Each subject subject will be randomly allocated to five single doses.
Administered subcutaneously (s.c, under the skin) on five dosing visits separated by 15-25 days.
The dose level will be 0.5 U/kg Body Weight (BW).
Each subject subject will be randomly allocated to five single doses.
Administered subcutaneously (s.c, under the skin) on five dosing visits separated by 15-25 days.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Area under the glucose infusion rate curve
Time Frame: From 0 to 6 hours after single dose (IDegAsp 15, IDeg and IDegAsp)
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From 0 to 6 hours after single dose (IDegAsp 15, IDeg and IDegAsp)
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Area under the serum IDeg concentration-time curve
Time Frame: From 0 to 120 hours after single dose
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From 0 to 120 hours after single dose
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Area under the serum IAsp concentration-time curve
Time Frame: From 0 to 12 hours after single dose
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From 0 to 12 hours after single dose
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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
January 1, 2013
Primary Completion (Actual)
August 1, 2013
Study Completion (Actual)
August 1, 2013
Study Registration Dates
First Submitted
January 18, 2013
First Submitted That Met QC Criteria
January 18, 2013
First Posted (Estimate)
January 23, 2013
Study Record Updates
Last Update Posted (Estimate)
March 5, 2015
Last Update Submitted That Met QC Criteria
March 4, 2015
Last Verified
March 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Glucose Metabolism Disorders
- Metabolic Diseases
- Immune System Diseases
- Autoimmune Diseases
- Endocrine System Diseases
- Diabetes Mellitus
- Diabetes Mellitus, Type 1
- Hypoglycemic Agents
- Physiological Effects of Drugs
- Insulin
- Insulin, Globin Zinc
- Insulin Aspart
- Insulin, Long-Acting
- Insulin degludec, insulin aspart drug combination
Other Study ID Numbers
- NN1050-4008
- 2012-004215-31 (EudraCT Number)
- U1111-1134-6222 (Other Identifier: WHO)
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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