Comparison of Insulin Detemir With NPH Insulin in Type 1 Diabetes
NCT ID: NCT00184665
Last Updated: 2017-01-27
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
501 participants
INTERVENTIONAL
2004-06-30
2006-09-30
Brief Summary
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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
* Currently on basal-bolus regimen
* BMI = 35.0 kg/m2
* HbA1c =11.0%
Exclusion Criteria
* Recurrent major hypoglycaemia
* Cardial problems
* Uncontrolled hypertension
* Impaired hepatic or renal function
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
Buenos Aires, , Argentina
Novo Nordisk Investigational Site
Ciudad Autonoma de Bs As, , Argentina
Novo Nordisk Investigational Site
Ciudad Autónoma de BsAs, , Argentina
Novo Nordisk Investigational Site
Mar del Plata, , Argentina
Novo Nordisk Investigational Site
St Leonards, New South Wales, Australia
Novo Nordisk Investigational Site
Hobart, Tasmania, Australia
Novo Nordisk Investigational Site
Melbourne, Victoria, Australia
Novo Nordisk Investigational Site
Darlinghurst, , Australia
Novo Nordisk Investigational Site
Melbourne, , Australia
Novo Nordisk Investigational Site
Stones Corner, , Australia
Novo Nordisk Investigational Site
Woodville, , Australia
Novo Nordisk Investigational Site
Plovdiv, , Bulgaria
Novo Nordisk Investigational Site
Sofia, , Bulgaria
Novo Nordisk Investigational Site
Zagreb, , Croatia
Novo Nordisk Investigational Site
Vellore, Tamil Nadu, India
Novo Nordisk Investigational Site
Chennai, , India
Novo Nordisk Investigational Site
Hyderabad, , India
Novo Nordisk Investigational Site
Mumbai, , India
Novo Nordisk Investigational Site
Cheras, , Malaysia
Novo Nordisk Investigational Site
Kota Bharu, Kelantan, , Malaysia
Novo Nordisk Investigational Site
Skopje, , North Macedonia
Novo Nordisk Investigational Site
Bucharest, , Romania
Novo Nordisk Investigational Site
Bucharest, , Romania
Novo Nordisk Investigational Site
Johannesburg, Gauteng, South Africa
Novo Nordisk Investigational Site
Johannesburg, Gauteng, South Africa
Novo Nordisk Investigational Site
Cape Town, Western Cape, South Africa
Novo Nordisk Investigational Site
Bloemfontein, , South Africa
Novo Nordisk Investigational Site
Bornova-IZMIR, , Turkey (Türkiye)
Novo Nordisk Investigational Site
Istanbul, , Turkey (Türkiye)
Countries
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References
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Bartley PC, Bogoev M, Larsen J, Philotheou A. Long-term efficacy and safety of insulin detemir compared to Neutral Protamine Hagedorn insulin in patients with Type 1 diabetes using a treat-to-target basal-bolus regimen with insulin aspart at meals: a 2-year, randomized, controlled trial. Diabet Med. 2008 Apr;25(4):442-9. doi: 10.1111/j.1464-5491.2007.02407.x.
Gschwend MH, Aagren M, Valentine WJ. Cost-effectiveness of insulin detemir compared with neutral protamine Hagedorn insulin in patients with type 1 diabetes using a basal-bolus regimen in five European countries. J Med Econ. 2009 Jun;12(2):114-23. doi: 10.3111/13696990903080344.
Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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NN304-1595
Identifier Type: -
Identifier Source: org_study_id
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