Comparison of Insulin Detemir or Insulin Glargine as Add on to Oral Antidiabetic Drugs in Type 2 Diabetes

NCT ID: NCT00283751

Last Updated: 2017-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

583 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-03-31

Study Completion Date

2004-11-30

Brief Summary

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This trial is conducted in Europe and the United States of America (USA). The aim of the trial is to test if Insulin Detemir as add-on to current Oral Antidiabetic Drug treatment is at least as effective as Insulin Glargine as add-on to current Oral Antidiabetic Drug treatment in reducing HbA1c in patients with Type 2 Diabetes.

Detailed Description

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Conditions

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Diabetes Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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insulin detemir

Intervention Type DRUG

insulin glargine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Type 2 Diabetes for more than 12 months, and no previous insulin treatment
* Oral Antidiabetic Drug treatment for at least 4 months
* Body Mass Index (BMI) less than 40 kg/m2
* HbA1c 7.5-10.0%

Exclusion Criteria

* Current or previous treatment with thiazolidinediones within the last 6 months
* Oral Antidiabetic Drug treatment with combination of three or more Oral Antidiabetic Drugs within the last 6 months
* Proliferative retinopathy or maculopathy
* Known hypoglycaemia unawareness
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Global Clinical Registry (GCR, 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Novo Nordisk Investigational Site

Greenbrae, California, United States

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La Mesa, California, United States

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West Palm Beach, Florida, United States

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Atlanta, Georgia, United States

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Chicago, Illinois, United States

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Springfield, Illinois, United States

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Topeka, Kansas, United States

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Chesterfield, Missouri, United States

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St Louis, Missouri, United States

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Lincoln, Nebraska, United States

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Pleasantville, New Jersey, United States

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Cleveland, Ohio, United States

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Kettering, Ohio, United States

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Philadelphia, Pennsylvania, United States

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Mt. Pleasant, South Carolina, United States

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Dallas, Texas, United States

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Dallas, Texas, United States

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Dallas, Texas, United States

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San Antonio, Texas, United States

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Warrenton, Virginia, United States

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Seattle, Washington, United States

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Ebreichsdorf, , Austria

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Gratwein, , Austria

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Graz, , Austria

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Neunkirchen, , Austria

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Vienna, , Austria

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Vienna, , Austria

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Wolfsberg, , Austria

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Bonheiden, , Belgium

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Brussels, , Belgium

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Edegem, , Belgium

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Ghent, , Belgium

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Leuven, , Belgium

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Besançon, , France

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Bondy, , France

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Grenoble, , France

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La Rochelle, , France

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Lyon, , France

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Nantes, , France

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Narbonne, , France

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Nîmes, , France

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Paris, , France

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Paris, , France

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Poitiers, , France

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Strasbourg, , France

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Toulouse, , France

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Bad Kreuznach, , Germany

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Bad Mergentheim, , Germany

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Bad Neuenahr-Ahrweiler, , Germany

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Berlin, , Germany

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Dresden, , Germany

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Flensburg, , Germany

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Frankfurt, , Germany

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Freiburg im Breisgau, , Germany

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Friedrichsthal, , Germany

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Fürth, , Germany

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Genthin, , Germany

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Giessen, , Germany

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Hamburg, , Germany

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Hamburg, , Germany

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Hamburg, , Germany

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Heidelberg, , Germany

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Krefeld, , Germany

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Ludwigshafen, , Germany

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Marl, , Germany

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München, , Germany

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Neumünster, , Germany

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Neuss, , Germany

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Nuremberg, , Germany

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Rehlingen-Siersburg, , Germany

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Saarbrücken, , Germany

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Saint Ingbert, , Germany

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Schaafheim, , Germany

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Schwabenheim, , Germany

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Schwedt, , Germany

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Völklingen, , Germany

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Würzburg, , Germany

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Dublin, , Ireland

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Dublin, , Ireland

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Ayr, , United Kingdom

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Barnsley, , United Kingdom

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Bolton, , United Kingdom

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Bradford, , United Kingdom

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Church Village, , United Kingdom

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Cosham, , United Kingdom

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Dundee, , United Kingdom

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Glasgow, , United Kingdom

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Harrow, , United Kingdom

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Leicester, , United Kingdom

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Leicester, , United Kingdom

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Livingstone, , United Kingdom

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London, , United Kingdom

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Newcastle, , United Kingdom

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Poole, , United Kingdom

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Salford, , United Kingdom

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Swansea, , United Kingdom

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Countries

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United States Austria Belgium France Germany Ireland United Kingdom

References

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Rosenstock J, Davies M, Home PD, Larsen J, Koenen C, Schernthaner G. A randomised, 52-week, treat-to-target trial comparing insulin detemir with insulin glargine when administered as add-on to glucose-lowering drugs in insulin-naive people with type 2 diabetes. Diabetologia. 2008 Mar;51(3):408-16. doi: 10.1007/s00125-007-0911-x. Epub 2008 Jan 16.

Reference Type RESULT
PMID: 18204830 (View on PubMed)

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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NN304-1373

Identifier Type: -

Identifier Source: org_study_id

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