A Trial Investigating the Effect of NN1250 in Japanese Subjects With Type 2 Diabetes
Primary Purpose
Diabetes, Diabetes Mellitus, Type 2
Status
Terminated
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
insulin degludec
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
NN1250
Arm Description
Outcomes
Primary Outcome Measures
Area under the glucose infusion rate curve during one dosing interval at steady state
Secondary Outcome Measures
Maximum glucose infusion rate at steady state
Area under the serum insulin degludec concentration-time curve during one dosing interval at steady state
Maximum observed serum insulin degludec concentration at steady state
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01467414
Brief Title
A Trial Investigating the Effect of NN1250 in Japanese Subjects With Type 2 Diabetes
Official Title
A Trial Investigating the Pharmacodynamic Properties of NN1250 in Japanese Subjects With Type 2 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
November 2013
Overall Recruitment Status
Terminated
Why Stopped
This trial was terminated due to low recruitment
Study Start Date
October 2011 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Diabetes Mellitus, Type 2
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NN1250
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
insulin degludec
Intervention Description
Injected s.c. (under the skin) once daily for 6 days
Primary Outcome Measure Information:
Title
Area under the glucose infusion rate curve during one dosing interval at steady state
Time Frame
Within 0-24 hours after last dosing
Secondary Outcome Measure Information:
Title
Maximum glucose infusion rate at steady state
Time Frame
Within 0-24 hours after last dosing
Title
Area under the serum insulin degludec concentration-time curve during one dosing interval at steady state
Time Frame
Within 0-24 hours after last dosing
Title
Maximum observed serum insulin degludec concentration at steady state
Time Frame
Within 0-24 hours after last dosing
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
City
Neuss
ZIP/Postal Code
41460
Country
Germany
12. IPD Sharing Statement
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk
Learn more about this trial
A Trial Investigating the Effect of NN1250 in Japanese Subjects With Type 2 Diabetes
We'll reach out to this number within 24 hrs