Efficacy and the Safety of Insulin Detemir in Subjects With Insulin Requiring Diabetes
NCT ID: NCT00604344
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
401 participants
INTERVENTIONAL
2003-04-30
2005-03-31
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
Eligibility Criteria
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Inclusion Criteria
* Current treatment of basal-bolus regimen for at least 12 weeks using an intermediate/long-acting human insulin and insulin aspart
* HbA1C below 11.0%
Exclusion Criteria
* Impaired hepatic function
* Serious heart diseases
* Known hypoglycaemia unawareness or recurrent major hypoglycaemia
* Proliferative retinopathy or maculopathy requiring acute treatment
* Uncontrolled treated/untreated hypertension
* Current treatment with total insulin dose of more than 100 IU/day
* Current treatment or expected at the screening to start treatment with systemic corticosteroids
20 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
Tokyo, , Japan
Countries
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References
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Kobayashi M, Iwamoto Y, Kaku K, Kawamori R, Tajima N. 48-week Randomized Multicenter Open-label Parallel Group Phase 3 Trial to Compare Insulin Detemir and NPH Insulin Efficacy and Safety in Subjects with Insulin Requriring Diabetes Mellitus in a Basal-bolus Regimen. J. Japan Diab. Soc 2007; 50 (9): 649-663
Kobayashi M, Iwamoto Y, Kawamori R, Tajima N, Nishida T, Kaku K. Insulin detemir achieves lower, less variable fasting glucose and a reduced risk of nocturnal hypoglycaemia and weight gain compared to NPH insulin in basal bolus therapy of Japanese patients with type 1 diabetes. Diabetologia 2006; 49 (Suppl 1): A608-A609 [Abstract 995]
Ishii H, Iwamoto Y, Kaku K, Kawamori R, Tajima N, Kobayashi M. Quality of Life (QoL) Assessment of Insulin Detemir and NPH Human Insulin in Japanese Subjects with Diabetes on Basal-Bolus Regimen. Diabetes 2007; 56 (Suppl. 1): A170 (2805-PO)
Semlitsch T, Engler J, Siebenhofer A, Jeitler K, Berghold A, Horvath K. (Ultra-)long-acting insulin analogues versus NPH insulin (human isophane insulin) for adults with type 2 diabetes mellitus. Cochrane Database Syst Rev. 2020 Nov 9;11(11):CD005613. doi: 10.1002/14651858.CD005613.pub4.
Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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JapicCTI-R070008
Identifier Type: REGISTRY
Identifier Source: secondary_id
NN304-1476
Identifier Type: -
Identifier Source: org_study_id
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