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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
  Purpose
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.

Condition Intervention Phase
Diabetes Diabetes Mellitus, Type 2 Drug: insulin degludec Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Trial Investigating the Pharmacodynamic Properties of NN1250 in Japanese Subjects With Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • 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 Measures:
  • 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 ]

Enrollment: 1
Study Start Date: October 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NN1250 Drug: insulin degludec
Injected s.c. (under the skin) once daily for 6 days

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01467414


Locations
Germany
Neuss, Germany, 41460
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01467414     History of Changes
Other Study ID Numbers: NN1250-3763
2011-001850-27 ( EudraCT Number )
U1111-1120-7444 ( Other Identifier: WHO )
First Submitted: October 31, 2011
First Posted: November 8, 2011
Last Update Posted: November 27, 2013
Last Verified: November 2013

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases