Study Stopped
This trial was terminated due to low recruitment
A Trial Investigating the Effect of NN1250 in Japanese Subjects With Type 2 Diabetes
A Trial Investigating the Pharmacodynamic Properties of NN1250 in Japanese Subjects With Type 2 Diabetes
3 other identifiers
interventional
1
1 country
1
Brief Summary
This trial is conducted in Europe. The aim of this clinical trial is to investigate the pharmacodynamic (the effect of the investigated drug on the body) properties of NN1250 (insulin degludec) in Japanese subjects with type 2 diabetes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 diabetes
Started Oct 2011
Shorter than P25 for phase_1 diabetes
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2011
CompletedFirst Submitted
Initial submission to the registry
October 31, 2011
CompletedFirst Posted
Study publicly available on registry
November 8, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedNovember 27, 2013
November 1, 2013
2 months
October 31, 2011
November 26, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Area under the glucose infusion rate curve during one dosing interval at steady state
Within 0-24 hours after last dosing
Secondary Outcomes (3)
Maximum glucose infusion rate at steady state
Within 0-24 hours after last dosing
Area under the serum insulin degludec concentration-time curve during one dosing interval at steady state
Within 0-24 hours after last dosing
Maximum observed serum insulin degludec concentration at steady state
Within 0-24 hours after last dosing
Study Arms (1)
NN1250
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Male or female Japanese subject aged 20-70 years (both inclusive)
- Japanese passport holder
- Japanese-born parents
- Type 2 diabetes mellitus (as diagnosed clinically) for at least 12 months
- Treated with insulin for at least 3 months
- Body Mass Index (BMI) maximum 33.0 kg/m\^2
- Glycosylated haemoglobin A1c (HbA1c) maximum 10.0%
- Fasting C-peptide below 1.0 nmol/L
You may not qualify if:
- Use of oral antidiabetic drugs (OADs) and/or glucagon like peptide-1 (GLP-1) receptor agonists (exenatide, liraglutide) within 3 months prior to screening
- Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
- Not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period
- Supine blood pressure at screening (after resting for 5 min) minimum 180 mmHg for systolic and/or minimum 100 mmHg for diastolic
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
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 31, 2011
First Posted
November 8, 2011
Study Start
October 1, 2011
Primary Completion
December 1, 2011
Study Completion
December 1, 2011
Last Updated
November 27, 2013
Record last verified: 2013-11