A Trial Investigating the Effect of NN5401 in Subjects With Type 2 Diabetes
A Trial Investigating the Pharmacodynamic Response of NN5401 in Subjects With Type 2 Diabetes
3 other identifiers
interventional
39
1 country
1
Brief Summary
This trial is conducted in Europe. The aim of this trial is to evaluate the blood glucose-lowering effect of NN5401 (insulin degludec/insulin aspart (IDegAsp)) in subjects with type 2 diabetes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 diabetes
Started May 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2010
CompletedFirst Submitted
Initial submission to the registry
May 27, 2010
CompletedFirst Posted
Study publicly available on registry
May 31, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2010
CompletedNovember 27, 2013
November 1, 2013
6 months
May 27, 2010
November 26, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Area under the glucose infusion rate curve (only for IDegAsp)
From 0 to 24 hours after single-dose
Secondary Outcomes (2)
Area under the insulin aspart concentration-time curve
From 0 to 12 hours after single-dose administration
Area under the insulin aspart concentration-time curve (only for BIAsp 30)
From 0 to 24 hours after single-dose administration
Study Arms (6)
NN5401 - low dose
EXPERIMENTALNN5401 - medium dose
EXPERIMENTALNN5401 - high dose
EXPERIMENTALbiphasic insulin aspart 30 - low dose
ACTIVE COMPARATORbiphasic insulin aspart 30 - medium dose
ACTIVE COMPARATORbiphasic insulin aspart 30 - high dose
ACTIVE COMPARATORInterventions
0.4 U/kg body weight injected subcutaneously (under the skin) once
0.4 U/kg body weight injected subcutaneously (under the skin) once
Eligibility Criteria
You may qualify if:
- Type 2 diabetes mellitus (as diagnosed clinically) for at least 12 months
- Body mass index below or equal to 35.0 kg/m\^2
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novo Nordisk A/Slead
Study Sites (1)
Unknown Facility
Neuss, 41460, Germany
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Global Clinical Registry (GCR, 1452)
Novo Nordisk A/S
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 27, 2010
First Posted
May 31, 2010
Study Start
May 1, 2010
Primary Completion
November 1, 2010
Study Completion
November 1, 2010
Last Updated
November 27, 2013
Record last verified: 2013-11