A Trial Investigating the Effect of NN1250 in Japanese Subjects With Type 1 Diabetes

January 19, 2017 updated by: Novo Nordisk A/S

A Trial Investigating the Pharmacodynamic Properties of NN1250 in Japanese Subjects With Type 1 Diabetes

This trial is conducted in Japan. The aim of this clinical trial is to investigate the effect of NN1250 (insulin degludec) in Japanese subjects with type 1 diabetes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

22

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

  • Japan
      • Tokyo, Japan, 130-0004
        • Novo Nordisk Investigational Site

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 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months
  • Treated with multiple daily insulin injections or continuous subcutaneous insulin infusion (CSII) for at least 12 months
  • Current daily basal insulin requirement above or equal to 0.3 (I)U/kg/day
  • Glycosylated haemoglobin A1c (HbA1c) below or equal to 10.0% (one retest within a week is permitted with the result of the last test being conclusive)

Exclusion Criteria:

  • Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
  • Surgery or trauma with significant blood loss (more than 500 mL) within the last 3 months prior to screening
  • Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day)
  • Not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period (only clamp period)

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: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: B
Drug: insulin detemir
Insulin detemir injected s.c. (under the skin) once daily for 6 days
Experimental: A
Drug: insulin degludec
NN1250 (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 NN1250 GIR (glucose infusion rate) curve
Time Frame: During one dosing interval at steady state
During one dosing interval at steady state

Secondary Outcome Measures

Outcome Measure
Time Frame
Area under the serum insulin detemir concentration-time curve
Time Frame: During one dosing interval at steady state
During one dosing interval at steady state

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.

General Publications

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

June 1, 2010

Primary Completion (Actual)

October 1, 2010

Study Completion (Actual)

October 1, 2010

Study Registration Dates

First Submitted

May 31, 2010

First Submitted That Met QC Criteria

May 31, 2010

First Posted (Estimate)

June 3, 2010

Study Record Updates

Last Update Posted (Estimate)

January 20, 2017

Last Update Submitted That Met QC Criteria

January 19, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN1250-1996
  • U1111-1113-6722 (Other Identifier: WHO)
  • JapicCTI-101158 (Other Identifier: JAPIC)

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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