Evaluation of the Efficacy and Safety of Insulin Detemir Compared With That of NPH Insulin in Subjects With Type 1 Diabetes.

July 17, 2017 updated by: Novo Nordisk A/S

A Six Month, Multi-centre, Open-label, Parallel Efficacy and Safety Comparison of Insulin Detemir and NPH Insulin in Subjects With Type 1 Diabetes on a Basal-bolus Regimen.

The aim of this trial is to evaluate the efficacy and safety of insulin detemir using the 2400 nmol/mL formulation to optimise dosing in subjects with type 1 diabetes on a basal (once daily)-bolus regimen.

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.
752

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

  • Australia
      • Ashford, Australia, 5035
        • Novo Nordisk Investigational Site
      • Box Hill, Australia, 3128
        • Novo Nordisk Investigational Site
      • Clayton, Australia, 3168
        • Novo Nordisk Investigational Site
      • Garran, Australia, 2605
        • Novo Nordisk Investigational Site
      • Ringwood, Australia, 3134
        • Novo Nordisk Investigational Site
      • Stones Corner, Australia, 4120
        • Novo Nordisk Investigational Site
      • Woodville, Australia, 5011
        • Novo Nordisk Investigational Site
    • New South Wales
      • Broadmeadow, New South Wales, Australia, 2292
        • Novo Nordisk Investigational Site
  • Belgium
      • Bornem, Belgium, 2880
        • Novo Nordisk Investigational Site
      • Edegem, Belgium, 2650
        • Novo Nordisk Investigational Site
      • Gent, Belgium, 9000
        • Novo Nordisk Investigational Site
      • Leuven, Belgium, 3000
        • Novo Nordisk Investigational Site
      • Luxembourg, Belgium, 1210
        • Novo Nordisk Investigational Site
  • Denmark
      • Fredericia, Denmark, 7000
        • Novo Nordisk Investigational Site
      • Frederiksberg, Denmark, 2000
        • Novo Nordisk Investigational Site
      • Hvidovre, Denmark, 2650
        • Novo Nordisk Investigational Site
      • København, Denmark, 2400
        • Novo Nordisk Investigational Site
      • Middelfart, Denmark
        • Novo Nordisk Investigational Site
      • Odense, Denmark, 5000
        • Novo Nordisk Investigational Site
      • Vejle, Denmark, 7100
        • Novo Nordisk Investigational Site
      • Århus C, Denmark, 8000
        • Novo Nordisk Investigational Site
  • Finland
      • Espoo, Finland, 02740
        • Novo Nordisk Investigational Site
      • Helsinki, Finland, 00250
        • Novo Nordisk Investigational Site
      • Joensuu, Finland, 80210
        • Novo Nordisk Investigational Site
      • Kemi, Finland, 94100
        • Novo Nordisk Investigational Site
      • Vantaa, Finland, 01400
        • Novo Nordisk Investigational Site
  • France
      • ANGERS cedex 09, France, 49033
        • Novo Nordisk Investigational Site
      • Avignon, France, 84902
        • Novo Nordisk Investigational Site
      • Bondy, France, 93143
        • Novo Nordisk Investigational Site
      • Corbeil Essonnes, France, 91106
        • Novo Nordisk Investigational Site
      • LA ROCHELLE cedex, France, 17019
        • Novo Nordisk Investigational Site
      • Le Creusot, France, 71200
        • Novo Nordisk Investigational Site
      • MONTPELLIER cedex 5, France, 34295
        • Novo Nordisk Investigational Site
      • NEVERS cedex, France, 58033
        • Novo Nordisk Investigational Site
      • Narbonne, France, 11108
        • Novo Nordisk Investigational Site
      • Paris, France, 75877
        • Novo Nordisk Investigational Site
      • Paris, France, 75908
        • Novo Nordisk Investigational Site
      • Paris Cedex 10, France, 75475
        • Novo Nordisk Investigational Site
      • Poitiers, France, 86000
        • Novo Nordisk Investigational Site
      • Rennes, France, 35056
        • Novo Nordisk Investigational Site
  • Ireland
      • Dublin, Ireland, DUBLIN 8
        • Novo Nordisk Investigational Site
      • Dublin, Ireland
        • Novo Nordisk Investigational Site
  • Netherlands
      • Amersfoort, Netherlands, 3816 CP
        • Novo Nordisk Investigational Site
      • Apeldoorn, Netherlands, 7334 DZ
        • Novo Nordisk Investigational Site
      • Brunssum, Netherlands, 6442 BE
        • Novo Nordisk Investigational Site
      • Den Haag, Netherlands, 2512 VA
        • Novo Nordisk Investigational Site
      • Eindhoven, Netherlands, 5631 BM
        • Novo Nordisk Investigational Site
      • Haarlem, Netherlands, 2012 CE
        • Novo Nordisk Investigational Site
      • Hengelo, Netherlands, 7555 DL
        • Novo Nordisk Investigational Site
      • Utrecht, Netherlands, 3582 KE
        • Novo Nordisk Investigational Site
  • Norway
      • Bergen, Norway, NO-5012
        • Novo Nordisk Investigational Site
      • Jessheim, Norway, 2050
        • Novo Nordisk Investigational Site
      • Kongsvinger, Norway, 2226
        • Novo Nordisk Investigational Site
      • Oslo, Norway, 0407
        • Novo Nordisk Investigational Site
      • Oslo, Norway, 0284
        • Novo Nordisk Investigational Site
      • Sarpsborg, Norway, 1702
        • Novo Nordisk Investigational Site
      • Stavanger, Norway, 4011
        • Novo Nordisk Investigational Site
      • Stord, Norway, 5400
        • Novo Nordisk Investigational Site
      • Trondheim, Norway, 7006
        • Novo Nordisk Investigational Site
  • Sweden
      • Falun, Sweden, 791 82
        • Novo Nordisk Investigational Site
      • Helsingborg, Sweden, 251 87
        • Novo Nordisk Investigational Site
      • Karlstad, Sweden, 651 85
        • Novo Nordisk Investigational Site
      • Lund, Sweden, 221 85
        • Novo Nordisk Investigational Site
      • Skövde, Sweden, 541 85
        • Novo Nordisk Investigational Site
      • Stockholm, Sweden, 141 86
        • Novo Nordisk Investigational Site
      • Umeå, Sweden, 901 85
        • Novo Nordisk Investigational Site
      • Uppsala, Sweden, 751 85
        • Novo Nordisk Investigational Site
      • Värnamo, Sweden, 331 85
        • Novo Nordisk Investigational Site
      • Örebro, Sweden, 701 85
        • Novo Nordisk Investigational Site
  • United Kingdom
      • Abergavenny, United Kingdom, NP7 7EG
        • Novo Nordisk Investigational Site
      • Blackburn, United Kingdom, BB3 3LR
        • Novo Nordisk Investigational Site
      • Bolton, United Kingdom, BL1 4QS
        • Novo Nordisk Investigational Site
      • Bristol, United Kingdom, BS10 5NB
        • Novo Nordisk Investigational Site
      • Cosham, United Kingdom, PO6 3LY
        • Novo Nordisk Investigational Site
      • Derby, United Kingdom, DE7 1DY
        • Novo Nordisk Investigational Site
      • Gillingham, United Kingdom, ME7 5NY
        • Novo Nordisk Investigational Site
      • Glasgow, United Kingdom, G42 9TY
        • Novo Nordisk Investigational Site
      • Glasgow, United Kingdom, G4 0SF
        • Novo Nordisk Investigational Site
      • Guildford, United Kingdom, GU2 7XX
        • Novo Nordisk Investigational Site
      • Kettering, United Kingdom, NN16 8UZ
        • Novo Nordisk Investigational Site
      • Livingstone, United Kingdom, EH54 6PP
        • Novo Nordisk Investigational Site
      • Llantrisant, United Kingdom, CF72 8XR
        • Novo Nordisk Investigational Site
      • London, United Kingdom, SE1 7EH
        • Novo Nordisk Investigational Site
      • Newcastle, United Kingdom, NE7 7DN
        • Novo Nordisk Investigational Site
      • Northampton, United Kingdom, NN1 5BD
        • Novo Nordisk Investigational Site
      • Norwich, United Kingdom, NR1 3SR
        • Novo Nordisk Investigational Site
      • Nottingham, United Kingdom, NG5 1PB
        • Novo Nordisk Investigational Site
      • Oxford, United Kingdom, OX2 6HE
        • Novo Nordisk Investigational Site
      • Sheffield, United Kingdom, S5 7AU
        • Novo Nordisk Investigational Site
      • Sidcup, United Kingdom, DA14 6LT
        • Novo Nordisk Investigational Site
      • Stevenage, United Kingdom, SG1 4AB
        • Novo Nordisk Investigational Site
      • Taunton, United Kingdom, TA1 5DA
        • Novo Nordisk Investigational Site
      • York, United Kingdom, YO3 7HE
        • 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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Signed and dated informed consent obtained before any trial-related activities
  • Type 1 diabetes diagnosed and classified according to aetiology
  • Duration of type 1 diabetes equal to or more than 12 months
  • Glycosylated haemoglobin less than or equal to 12 percent based on analysis from central laboratory
  • Able and willing to perform self-blood glucose monitoring

Exclusion Criteria:

  • Proliferative retinopathy
  • Total basal insulin dose of more than 100 IU per day
  • Recurrent major hypoglycaemia - that would interfere with trial participation (as judged by the investigator)
  • Known unawareness of hypoglycaemia
  • Previous treatment with insulin detemir

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

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
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.
Experimental: Insulin detemir
Drug: Insulin detemir
Active Comparator: NPH insulin
Drug: NPH insulin

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
The change in the level of glycosylated haemoglobin(HbA1c)
Time Frame: From start of treatment visit 2 (week 0) until end of treatment visit 8 (week 26)
From start of treatment visit 2 (week 0) until end of treatment visit 8 (week 26)

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

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 (Actual)

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.
February 1, 2001

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.
November 12, 2001

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.
November 12, 2001

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).
July 13, 2017

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.
July 17, 2017

First Posted (Actual)

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.
July 18, 2017

Study Record Updates

Last Update Posted (Actual)

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.
July 18, 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.
July 17, 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.
July 1, 2017

More Information

Terms related to this study

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.
  • NN304-1335

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

According to the Novo Nordisk Disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

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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