The Effect of NN1250 in Subjects With Type 2 Diabetes of Different Race and/or Ethnic Origin

January 20, 2017 updated by: Novo Nordisk A/S

A Trial Investigating the Pharmacodynamic and Pharmacokinetic Properties of NN1250 at Steady State Conditions in Subjects With Type 2 Diabetes of Different Race and/or Ethnicity

This trial is conducted in the United States of America (USA). The aim of this trial is to investigate the pharmacodynamic (effect) and pharmacokinetic (exposure of drug) properties of NN1250 (insulin degludec, IDeg) in subjects with type 2 diabetes of different race and/or ethnicity.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

63

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

  • United States
    • California
      • Chula Vista, California, United States, 91911
        • 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

16 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Either - Black or African American not of Hispanic or Latino origin or - White of Hispanic or Latino origin or - White not of Hispanic or Latino origin
  • Type 2 diabetes mellitus (as diagnosed clinically) for at least 12 months
  • Treated with insulin for at least 3 months, alone or in combination with maximum 2 oral antidiabetic drugs (OADs)
  • Body mass index maximum 40.0 kg/m^2

Exclusion Criteria:

  • Use of GLP-1 receptor agonists (exenatide, liraglutide), thiazolidinediones or dipeptidyl peptidase-4 (DPP-4) inhibitors within 3 months prior to screening
  • History of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction
  • Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening

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
Experimental: A1, first period
Drug: insulin degludec
0.6 U/kg body weight injected subcutaneously (under the skin), once daily for 6 days
Active Comparator: A2, second period
Drug: insulin detemir
0.6 U/kg body weight injected subcutaneously (under the skin), once daily for 6 days
Active Comparator: B1, first period
Drug: insulin detemir
0.6 U/kg body weight injected subcutaneously (under the skin), once daily for 6 days
Experimental: B2, second period
Drug: insulin degludec
0.6 U/kg body weight injected subcutaneously (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: 0-24 hours (derived on treatment day 6)
0-24 hours (derived on treatment day 6)

Secondary Outcome Measures

Outcome Measure
Time Frame
Area under the Insulin Degludec concentration-time curve during one dosing interval at steady state
Time Frame: 0-24 hours (derived on treatment day 6)
0-24 hours (derived on treatment day 6)

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

January 1, 2010

Primary Completion (Actual)

October 1, 2010

Study Completion (Actual)

October 1, 2010

Study Registration Dates

First Submitted

January 5, 2010

First Submitted That Met QC Criteria

January 5, 2010

First Posted (Estimate)

January 6, 2010

Study Record Updates

Last Update Posted (Estimate)

January 23, 2017

Last Update Submitted That Met QC Criteria

January 20, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN1250-3762
  • U1111-1112-6185 (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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