Comparison of Efficacy and Safety of Insulin Detemir and Insulin Glargine in Patients With Type 1 Diabetes

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

Comparison of Efficacy and Safety of Insulin Detemir and Insulin Glargine in Patients With Type 1 Diabetes.

The trial is conducted in Europe and Africa. The aim of the trial is to compare the use of insulin detemir twice daily combined with mealtime insulin aspart against that of insulin glargine once daily combined with mealtime insulin aspart. The trial involves patients with Type 1 Diabetes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

325

Phase

  • 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

  • Austria
      • Graz, Austria, 8036
        • Novo Nordisk Investigational Site
      • Wien, Austria, 1090
        • Novo Nordisk Investigational Site
      • Wien, Austria, 1030
        • Novo Nordisk Investigational Site
      • Wien, Austria, A 1160
        • Novo Nordisk Investigational Site
      • Wien, Austria, A-1130
        • Novo Nordisk Investigational Site
  • Germany
      • Bad Kreuznach, Germany, 55545
        • Novo Nordisk Investigational Site
      • Bad Mergentheim, Germany, 97980
        • Novo Nordisk Investigational Site
      • Bad Neuenahr-Ahrweiler, Germany, 53474
        • Novo Nordisk Investigational Site
      • Berlin, Germany, 10789
        • Novo Nordisk Investigational Site
      • Diez, Germany, 65582
        • Novo Nordisk Investigational Site
      • Erlangen, Germany, 91052
        • Novo Nordisk Investigational Site
      • Essen, Germany, 45138
        • Novo Nordisk Investigational Site
      • Flensburg, Germany, 24939
        • Novo Nordisk Investigational Site
      • Frankfurt, Germany, 60590
        • Novo Nordisk Investigational Site
      • Friedrichsthal, Germany, 66299
        • Novo Nordisk Investigational Site
      • Genthin, Germany, 39307
        • Novo Nordisk Investigational Site
      • Halle, Germany, 06120
        • Novo Nordisk Investigational Site
      • Hamburg, Germany, 20251
        • Novo Nordisk Investigational Site
      • Hannover, Germany, 30171
        • Novo Nordisk Investigational Site
      • Heidelberg, Germany, 69115
        • Novo Nordisk Investigational Site
      • Hennigsdorf, Germany, 16761
        • Novo Nordisk Investigational Site
      • Hünxe, Germany, 46569
        • Novo Nordisk Investigational Site
      • Jena, Germany, 07743
        • Novo Nordisk Investigational Site
      • Kiel, Germany, 24105
        • Novo Nordisk Investigational Site
      • Landau, Germany, 76829
        • Novo Nordisk Investigational Site
      • Ludwigshafen, Germany, 67059
        • Novo Nordisk Investigational Site
      • Marl, Germany, 45770
        • Novo Nordisk Investigational Site
      • Mönchengladbach, Germany, 41061
        • Novo Nordisk Investigational Site
      • Neunkirchen, Germany, 66538
        • Novo Nordisk Investigational Site
      • Neuss, Germany, 41460
        • Novo Nordisk Investigational Site
      • Northeim, Germany, 37154
        • Novo Nordisk Investigational Site
      • Nürnberg, Germany, 90402
        • Novo Nordisk Investigational Site
      • Rehlingen-Siersburg, Germany, 66780
        • Novo Nordisk Investigational Site
      • Rheda-Wiedenbrück, Germany, 33378
        • Novo Nordisk Investigational Site
      • Saarbrücken, Germany, 66121
        • Novo Nordisk Investigational Site
      • Saarlouis, Germany, 66740
        • Novo Nordisk Investigational Site
      • Schwabenheim, Germany, 55270
        • Novo Nordisk Investigational Site
      • Schwerin, Germany, 19049
        • Novo Nordisk Investigational Site
      • Schönebeck, Germany, 39218
        • Novo Nordisk Investigational Site
      • Völklingen, Germany, 66333
        • Novo Nordisk Investigational Site
      • Wiesbaden, Germany, 65183
        • Novo Nordisk Investigational Site
      • Würzburg, Germany, 97072
        • Novo Nordisk Investigational Site
  • South Africa
    • Gauteng
      • Johannesburg, Gauteng, South Africa, 2193
        • Novo Nordisk Investigational Site
    • KwaZulu-Natal
      • Durban, KwaZulu-Natal, South Africa, 4091
        • Novo Nordisk Investigational Site
    • Western Cape
      • Cape Town, Western Cape, South Africa, 7130
        • Novo Nordisk Investigational Site
      • Cape Town, Western Cape, South Africa, 7925
        • 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

18 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 daily insulin dose of more than 1.4 IU/kg
  • BMI lesser than or equal to 35 kg/m2
  • HbA1c greater than 7.5% and less than or equal to 12.0%
  • In Austria, age more than 19 years

Exclusion Criteria:

  • Proliferate retinopathy or maculopathy
  • Recurrent major hypoglycaemia
  • Any condition or disease such as uncontrolled hypertension or AIDS/HIV that rule out trial participation according to the judgement of the investigator

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

Outcome Measure
Time Frame
HbA1c
Time Frame: after 26 weeks of treatment
after 26 weeks of treatment

Secondary Outcome Measures

Outcome Measure
Adverse events
Blood glucose
Hypoglycaemia
Body weight

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

April 1, 2002

Primary Completion (Actual)

March 1, 2003

Study Completion (Actual)

March 1, 2003

Study Registration Dates

First Submitted

April 5, 2006

First Submitted That Met QC Criteria

April 5, 2006

First Posted (Estimate)

April 7, 2006

Study Record Updates

Last Update Posted (Estimate)

January 27, 2017

Last Update Submitted That Met QC Criteria

January 26, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN304-1372

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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