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

November 26, 2013 updated by: Novo Nordisk A/S

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NN1250
Drug: insulin degludec
Injected s.c. (under the skin) once daily for 6 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Area under the glucose infusion rate curve during one dosing interval at steady state
Time Frame: Within 0-24 hours after last dosing
Within 0-24 hours after last dosing

Secondary Outcome Measures

Outcome Measure
Time Frame
Maximum glucose infusion rate at steady state
Time Frame: Within 0-24 hours after last dosing
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
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
Within 0-24 hours after last dosing

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

October 31, 2011

First Submitted That Met QC Criteria

November 4, 2011

First Posted (Estimate)

November 8, 2011

Study Record Updates

Last Update Posted (Estimate)

November 27, 2013

Last Update Submitted That Met QC Criteria

November 26, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN1250-3763
  • 2011-001850-27 (EudraCT Number)
  • U1111-1120-7444 (Other Identifier: WHO)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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