- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01076634
Comparison of Two NN1250 Formulations in Subjects With Type 1 Diabetes
January 20, 2017 updated by: Novo Nordisk A/S
A Trial Investigating the Pharmacodynamic Properties of NN1250 in Subjects With Type 1 Diabetes
This trial is conducted in Europe.
The aim of the trial is to investigate the pharmacodynamic properties (effect) by comparing two NN1250 (insulin degludec, IDeg) formulations in subjects with type 1 diabetes.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
- Novo Nordisk Investigational Site
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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 65 years (Adult, Older 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 and use of nicotine gum or transdermal nicotine patches during the inpatient period
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: IDeg 200 U/mL
|
0.4 U/kg body weight.
Injected subcutaneously (under the skin) once daily for 8 days.
|
Experimental: IDeg 100 U/mL
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0.4 U/kg body weight.
Injected subcutaneously (under the skin) once daily for 8 days.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Area under the glucose infusion rate curve during one dosing interval at steady-date"
Time Frame: After 8 days of treatment
|
After 8 days of treatment
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Area under the serum Insulin Degludec concentration-time curve
Time Frame: During one dosing interval at steady state
|
During one dosing interval at steady state
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Area under the serum Insulin Degludec concentration-time curve
Time Frame: From 0 to 24 hours after single dose
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From 0 to 24 hours after single dose
|
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
February 1, 2010
Primary Completion (Actual)
July 1, 2010
Study Completion (Actual)
July 1, 2010
Study Registration Dates
First Submitted
February 24, 2010
First Submitted That Met QC Criteria
February 25, 2010
First Posted (Estimate)
February 26, 2010
Study Record Updates
Last Update Posted (Estimate)
January 23, 2017
Last Update Submitted That Met QC Criteria
January 20, 2017
Last Verified
January 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NN1250-3678
- 2009-014555-68 (EudraCT Number)
- U1111-1112-7714 (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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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
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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
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-
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