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

NCT ID: NCT00312104

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

325 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-04-30

Study Completion Date

2003-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Diabetes Diabetes Mellitus, Type 1

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

insulin aspart

Intervention Type DRUG

Eligibility Criteria

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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
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

Graz, , Austria

Site Status

Novo Nordisk Investigational Site

Vienna, , Austria

Site Status

Novo Nordisk Investigational Site

Vienna, , Austria

Site Status

Novo Nordisk Investigational Site

Vienna, , Austria

Site Status

Novo Nordisk Investigational Site

Vienna, , Austria

Site Status

Novo Nordisk Investigational Site

Bad Kreuznach, , Germany

Site Status

Novo Nordisk Investigational Site

Bad Mergentheim, , Germany

Site Status

Novo Nordisk Investigational Site

Bad Neuenahr-Ahrweiler, , Germany

Site Status

Novo Nordisk Investigational Site

Berlin, , Germany

Site Status

Novo Nordisk Investigational Site

Diez, , Germany

Site Status

Novo Nordisk Investigational Site

Erlangen, , Germany

Site Status

Novo Nordisk Investigational Site

Essen, , Germany

Site Status

Novo Nordisk Investigational Site

Flensburg, , Germany

Site Status

Novo Nordisk Investigational Site

Frankfurt, , Germany

Site Status

Novo Nordisk Investigational Site

Friedrichsthal, , Germany

Site Status

Novo Nordisk Investigational Site

Genthin, , Germany

Site Status

Novo Nordisk Investigational Site

Halle, , Germany

Site Status

Novo Nordisk Investigational Site

Hamburg, , Germany

Site Status

Novo Nordisk Investigational Site

Hanover, , Germany

Site Status

Novo Nordisk Investigational Site

Heidelberg, , Germany

Site Status

Novo Nordisk Investigational Site

Hennigsdorf, , Germany

Site Status

Novo Nordisk Investigational Site

Hünxe, , Germany

Site Status

Novo Nordisk Investigational Site

Jena, , Germany

Site Status

Novo Nordisk Investigational Site

Kiel, , Germany

Site Status

Novo Nordisk Investigational Site

Landau, , Germany

Site Status

Novo Nordisk Investigational Site

Ludwigshafen, , Germany

Site Status

Novo Nordisk Investigational Site

Marl, , Germany

Site Status

Novo Nordisk Investigational Site

Mönchengladbach, , Germany

Site Status

Novo Nordisk Investigational Site

Neunkirchen, , Germany

Site Status

Novo Nordisk Investigational Site

Neuss, , Germany

Site Status

Novo Nordisk Investigational Site

Northeim, , Germany

Site Status

Novo Nordisk Investigational Site

Nuremberg, , Germany

Site Status

Novo Nordisk Investigational Site

Rehlingen-Siersburg, , Germany

Site Status

Novo Nordisk Investigational Site

Rheda-Wiedenbrück, , Germany

Site Status

Novo Nordisk Investigational Site

Saarbrücken, , Germany

Site Status

Novo Nordisk Investigational Site

Saarlouis, , Germany

Site Status

Novo Nordisk Investigational Site

Schönebeck, , Germany

Site Status

Novo Nordisk Investigational Site

Schwabenheim, , Germany

Site Status

Novo Nordisk Investigational Site

Schwerin, , Germany

Site Status

Novo Nordisk Investigational Site

Völklingen, , Germany

Site Status

Novo Nordisk Investigational Site

Wiesbaden, , Germany

Site Status

Novo Nordisk Investigational Site

Würzburg, , Germany

Site Status

Novo Nordisk Investigational Site

Johannesburg, Gauteng, South Africa

Site Status

Novo Nordisk Investigational Site

Durban, KwaZulu-Natal, South Africa

Site Status

Novo Nordisk Investigational Site

Cape Town, Western Cape, South Africa

Site Status

Novo Nordisk Investigational Site

Cape Town, Western Cape, South Africa

Site Status

Countries

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Austria Germany South Africa

References

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Pieber TR, Treichel HC, Hompesch B, Philotheou A, Mordhorst L, Gall MA, Robertson LI. Comparison of insulin detemir and insulin glargine in subjects with Type 1 diabetes using intensive insulin therapy. Diabet Med. 2007 Jun;24(6):635-42. doi: 10.1111/j.1464-5491.2007.02113.x. Epub 2007 Mar 22.

Reference Type RESULT
PMID: 17381500 (View on PubMed)

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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NN304-1372

Identifier Type: -

Identifier Source: org_study_id

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