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A Trial Investigating the Effect of NN1250 in Japanese Subjects With Type 2 Diabetes

This study has been terminated.
(This trial was terminated due to low recruitment)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01467414
First Posted: November 8, 2011
Last Update Posted: November 27, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
October 31, 2011
November 8, 2011
November 27, 2013
October 2011
December 2011   (Final data collection date for primary outcome measure)
Area under the glucose infusion rate curve during one dosing interval at steady state [ Time Frame: Within 0-24 hours after last dosing ]
Same as current
Complete list of historical versions of study NCT01467414 on ClinicalTrials.gov Archive Site
  • Maximum glucose infusion rate at steady state [ Time Frame: Within 0-24 hours after last dosing ]
  • 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 ]
  • Maximum observed serum insulin degludec concentration at steady state [ Time Frame: Within 0-24 hours after last dosing ]
Same as current
Not Provided
Not Provided
 
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
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.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Diabetes
  • Diabetes Mellitus, Type 2
Drug: insulin degludec
Injected s.c. (under the skin) once daily for 6 days
Experimental: NN1250
Intervention: Drug: insulin degludec
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
1
December 2011
December 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
20 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT01467414
NN1250-3763
2011-001850-27 ( EudraCT Number )
U1111-1120-7444 ( Other Identifier: WHO )
No
Not Provided
Not Provided
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Novo Nordisk A/S
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP