Safety and Efficacy of Insulin Detemir Plus Insulin Aspart Against Insulin Glargine Plus Insulin Aspart as Mealtime Insulin in Type 1 Diabetes

January 26, 2017 updated by: Novo Nordisk A/S

Efficacy and Safety Comparison of Insulin Detemir Plus Insulin Aspart Versus Insulin Glargine Plus Insulin Aspart in Type 1 Diabetes

This trial is conducted in Europe and the United States of America (USA). The purpose of this study is to test whether insulin detemir is a safe and at least as effective alternative to insulin glargine for the control of blood glucose in basal/bolus therapy in patients with type I diabetes.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
447

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

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

  • Finland
      • Helsinki, Finland, 00250
        • Novo Nordisk Investigational Site
      • Kuopio, Finland, 70210
        • Novo Nordisk Investigational Site
      • Oulu, Finland, 90029
        • Novo Nordisk Investigational Site
      • Pori, Finland, 28500
        • Novo Nordisk Investigational Site
      • Vantaa, Finland, 01400
        • Novo Nordisk Investigational Site
  • France
      • ANGERS cedex 09, France, 49033
        • Novo Nordisk Investigational Site
      • Antibes, France, 06600
        • Novo Nordisk Investigational Site
      • Brest, France, 29609
        • Novo Nordisk Investigational Site
      • GRENOBLE cedex, France, 38043
        • Novo Nordisk Investigational Site
      • LA ROCHELLE cedex, France, 17019
        • Novo Nordisk Investigational Site
      • Mougins, France, 06250
        • Novo Nordisk Investigational Site
      • TOULOUSE cedex, France, 31054
        • Novo Nordisk Investigational Site
  • Germany
      • Alsdorf, Germany, 52477
        • Novo Nordisk Investigational Site
      • Bad Kreuznach, Germany, 55545
        • Novo Nordisk Investigational Site
      • Dormagen, Germany, 41539
        • Novo Nordisk Investigational Site
      • Dresden, Germany, 01307
        • Novo Nordisk Investigational Site
      • Flensburg, Germany, 24939
        • Novo Nordisk Investigational Site
      • Friedrichsthal, Germany, 66299
        • Novo Nordisk Investigational Site
      • Genthin, Germany, 39307
        • Novo Nordisk Investigational Site
      • Hamburg, Germany, 20251
        • Novo Nordisk Investigational Site
      • Hamburg, Germany, 22607
        • Novo Nordisk Investigational Site
      • Hamburg, Germany, 21073
        • Novo Nordisk Investigational Site
      • Herrenberg, Germany, 71083
        • Novo Nordisk Investigational Site
      • Kippenheim, Germany, 77971
        • Novo Nordisk Investigational Site
      • Rehlingen-Siersburg, Germany, 66780
        • Novo Nordisk Investigational Site
      • Speyer, Germany, 67346
        • Novo Nordisk Investigational Site
      • St. Ingbert, Germany, 66386
        • Novo Nordisk Investigational Site
      • Völklingen, Germany, 66333
        • Novo Nordisk Investigational Site
      • Würzburg, Germany, 97072
        • Novo Nordisk Investigational Site
  • Netherlands
      • Almere, Netherlands, 1315 RA
        • Novo Nordisk Investigational Site
      • Apeldoorn, Netherlands, 7334 DZ
        • Novo Nordisk Investigational Site
      • Capelle a/d IJssel, Netherlands, 2906 ZC
        • Novo Nordisk Investigational Site
      • Dordrecht, Netherlands, 3318 AT
        • Novo Nordisk Investigational Site
      • Leeuwarden, Netherlands, 8934 AD
        • Novo Nordisk Investigational Site
      • Zoetermeer, Netherlands, 2725 NA
        • Novo Nordisk Investigational Site
  • Sweden
      • Norrköping, Sweden, 601 82
        • Novo Nordisk Investigational Site
      • Stockholm, Sweden, 112 81
        • Novo Nordisk Investigational Site
      • Stockholm, Sweden, 182 88
        • Novo Nordisk Investigational Site
      • Umeå, Sweden, 901 85
        • Novo Nordisk Investigational Site
      • Växjö, Sweden, 351 85
        • Novo Nordisk Investigational Site
      • Örebro, Sweden, 701 85
        • Novo Nordisk Investigational Site
  • United Kingdom
      • Abergavenny, United Kingdom, NP7 7EG
        • Novo Nordisk Investigational Site
      • Ayr, United Kingdom, KA6 6DX
        • Novo Nordisk Investigational Site
      • Brighton, United Kingdom, BN2 5BE
        • Novo Nordisk Investigational Site
      • Bristol, United Kingdom, BS10 5NB
        • Novo Nordisk Investigational Site
      • Cosham, United Kingdom, PO6 3LY
        • Novo Nordisk Investigational Site
      • Dundee, United Kingdom, DD1 9SY
        • Novo Nordisk Investigational Site
      • Glasgow, United Kingdom, G4 0SF
        • Novo Nordisk Investigational Site
      • Livingstone, United Kingdom, EH54 6PP
        • Novo Nordisk Investigational Site
      • Plymouth, United Kingdom, PL8 8DQ
        • Novo Nordisk Investigational Site
      • Sheffield, United Kingdom, S5 7AU
        • Novo Nordisk Investigational Site
      • Watford, United Kingdom, WD18 0HB
        • Novo Nordisk Investigational Site
      • Wirral, Merseyside, United Kingdom, CH63 4JY
        • Novo Nordisk Investigational Site
  • United States
    • California
      • Anaheim, California, United States, 92801
        • Novo Nordisk Investigational Site
      • Huntington Beach, California, United States, 92646
        • Novo Nordisk Investigational Site
      • Inglewood, California, United States, 90301
        • Novo Nordisk Investigational Site
      • Irvine, California, United States, 92618
        • Novo Nordisk Investigational Site
      • La Jolla, California, United States, 92037
        • Novo Nordisk Investigational Site
    • Florida
      • Hollywood, Florida, United States, 33021
        • Novo Nordisk Investigational Site
      • Jacksonville, Florida, United States, 32216
        • Novo Nordisk Investigational Site
      • Lake Mary, Florida, United States, 32746
        • Novo Nordisk Investigational Site
      • Melbourne, Florida, United States, 32901
        • Novo Nordisk Investigational Site
      • Tampa, Florida, United States, 33613
        • Novo Nordisk Investigational Site
      • Vero Beach, Florida, United States, 32960
        • Novo Nordisk Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30318
        • Novo Nordisk Investigational Site
    • Idaho
      • Idaho Falls, Idaho, United States, 83404-7596
        • Novo Nordisk Investigational Site
    • Illinois
      • Chicago, Illinois, United States, 60607
        • Novo Nordisk Investigational Site
    • Kansas
      • Topeka, Kansas, United States, 66606
        • Novo Nordisk Investigational Site
    • Maryland
      • Hyattsville, Maryland, United States, 20782
        • Novo Nordisk Investigational Site
    • Michigan
      • Detroit, Michigan, United States, 48235
        • Novo Nordisk Investigational Site
    • Missouri
      • St. Louis, Missouri, United States, 63110
        • Novo Nordisk Investigational Site
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Novo Nordisk Investigational Site
    • Nevada
      • Las Vegas, Nevada, United States, 89119-6100
        • Novo Nordisk Investigational Site
    • New Jersey
      • Berlin, New Jersey, United States, 08009
        • Novo Nordisk Investigational Site
      • Sea Girt, New Jersey, United States, 08750
        • Novo Nordisk Investigational Site
    • North Carolina
      • Asheville, North Carolina, United States, 28803
        • Novo Nordisk Investigational Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Novo Nordisk Investigational Site
    • Texas
      • Dallas, Texas, United States, 75235
        • Novo Nordisk Investigational Site
      • Dallas, Texas, United States, 75390-8858
        • Novo Nordisk Investigational Site
      • Houston, Texas, United States, 77030
        • Novo Nordisk Investigational Site
      • San Antonio, Texas, United States, 78229
        • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Type 1 diabetes for at least 12 months
  • Current treatment with basal-bolus insulin regimen for more than or equal to 3 months
  • HbA1c less than or equal to 11.0%

Exclusion Criteria:

  • Proliferative retinopathy or maculopathy
  • Recurrent major hypoglycaemia
  • Impaired hepatic or renal function
  • Cardiac problems or uncontrolled hypertension

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: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
HbA1c
Time Frame: after 1 year trial period
after 1 year trial period

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Adverse events
Blood glucose
Body weight
Hypoglycemia
Insulin Treatment Satisfaction

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2004

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2005

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2005

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 29, 2004

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 29, 2004

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 1, 2004

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 27, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 26, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NN304-1430
  • 2004-000086-35 (EudraCT Number)

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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