Efficacy and Safety of Insulin Detemir in Type 1 Diabetes
NCT ID: NCT00595374
Last Updated: 2017-02-24
Study Results
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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COMPLETED
PHASE3
114 participants
INTERVENTIONAL
2003-12-02
2004-10-07
Brief Summary
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The aim of this trial is to compare the efficacy and safety of insulin detemir and insulin NPH in adults with type 1 diabetes on blood glucose control.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Interventions
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insulin detemir
insulin NPH
insulin aspart
Eligibility Criteria
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Inclusion Criteria
* BMI below 35 kg/m2
* HbA1c between 7.0-12.0%
* Current treatment with preprandial short acting insulin and insulin NPH once or twice daily for at least 6 months
* Fertile females must use acceptable method of contraception if there is any risk of pregnancy in the opinion of the Investigator
Exclusion Criteria
* Previous participation in this trial
* Receipt of any investigational products within the last 2 months prior to this trial
* Drug or alcohol dependence
* Pregnancy, breast-feeding or intention of becoming pregnant
18 Years
ALL
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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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
Amersfoort, , Netherlands
Novo Nordisk Investigational Site
Apeldoorn, , Netherlands
Novo Nordisk Investigational Site
Den Helder, , Netherlands
Novo Nordisk Investigational Site
Deventer, , Netherlands
Novo Nordisk Investigational Site
Enschede, , Netherlands
Novo Nordisk Investigational Site
Gouda, , Netherlands
Novo Nordisk Investigational Site
Hoogeveen, , Netherlands
Novo Nordisk Investigational Site
Leidschendam, , Netherlands
Novo Nordisk Investigational Site
Meppel, , Netherlands
Novo Nordisk Investigational Site
Rotterdam, , Netherlands
Novo Nordisk Investigational Site
Stadskanaal, , Netherlands
Novo Nordisk Investigational Site
The Hague, , Netherlands
Novo Nordisk Investigational Site
The Hague, , Netherlands
Novo Nordisk Investigational Site
Utrecht, , Netherlands
Novo Nordisk Investigational Site
Waalwijk, , Netherlands
Novo Nordisk Investigational Site
Weert, , Netherlands
Novo Nordisk Investigational Site
Zevenaar, , Netherlands
Novo Nordisk Investigational Site
Zwolle, , Netherlands
Countries
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Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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NN304-1582
Identifier Type: -
Identifier Source: org_study_id
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