A Trial Investigating the Pharmacodynamic Properties of NN5401 in Subjects With Type 1 Diabetes
NCT ID: NCT01590836
Last Updated: 2017-02-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
22 participants
INTERVENTIONAL
2012-04-30
2012-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Investigation of the Response Relationship of NN5401 in Type 1 Diabetics
NCT00993096
A Trial Investigating the Effect of NN5401 in Subjects With Type 2 Diabetes
NCT01134224
Comparison of the Effect of NN5401 With the Effect of NN1250 and Insulin Aspart in Subjects With Type 1 Diabetes
NCT01173926
A Trial Investigating the Total Exposure of NN5401 (Insulin Degludec/Insulin Aspart) in Children, Adolescents and Adult Subjects With Type 1 Diabetes
NCT01138488
Comparison of the Effect of NN5401 With the Effect of NN1250 and Insulin Aspart in Type 1 Diabetics
NCT00992537
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
IDeg-->IDegAsp
insulin degludec
Administered subcutaneously (s.c., under the skin) once daily (plus insulin aspart as bolus insulin as required).
insulin degludec/insulin aspart
Single dose administered subcutaneously (s.c., under the skin).
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
insulin degludec
Administered subcutaneously (s.c., under the skin) once daily (plus insulin aspart as bolus insulin as required).
insulin degludec/insulin aspart
Single dose administered subcutaneously (s.c., under the skin).
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Treated with multiple daily insulin injections or continuous subcutaneous insulin infusion (CSII) for at least 12 months
* Body mass index (BMI) 18.0-28.0 kg/m\^2 (both inclusive)
* Glycosylated haemoglobin (HbA1c) maximum 9.5 %
* Fasting C-peptide maximum 0.3 nmol/L
Exclusion Criteria
* Not able or willing to refrain from smoking, use of nicotine gum or transdermal nicotine patches during the inpatient period
* Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
* Surgery or trauma with significant blood loss (more than 500 mL) within the last 3 months prior to screening
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Novo Nordisk A/S
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Global Clinical Registry (GCR, 1452)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Novo Nordisk Investigational Site
Neuss, , Germany
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Heise T, Nosek L, Roepstorff C, Chenji S, Klein O, Haahr H. Distinct Prandial and Basal Glucose-Lowering Effects of Insulin Degludec/Insulin Aspart (IDegAsp) at Steady State in Subjects with Type 1 Diabetes Mellitus. Diabetes Ther. 2014 Jun;5(1):255-65. doi: 10.1007/s13300-014-0070-2. Epub 2014 Jun 3.
Related Links
Access external resources that provide additional context or updates about the study.
Clinical Trials at Novo Nordisk
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2011-003797-90
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U1111-1123-3837
Identifier Type: OTHER
Identifier Source: secondary_id
NN5401-1979
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.