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:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01467414
First received: October 31, 2011
Last updated: November 26, 2013
Last verified: November 2013
  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
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Maximum glucose infusion rate at steady state [ Time Frame: Within 0-24 hours after last dosing ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Maximum observed serum insulin degludec concentration at steady state [ Time Frame: Within 0-24 hours after last dosing ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01467414     History of Changes
Other Study ID Numbers: NN1250-3763, 2011-001850-27, U1111-1120-7444
Study First Received: October 31, 2011
Last Updated: November 26, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

ClinicalTrials.gov processed this record on September 30, 2014