Efficacy and Safety of Biphasic Insulin Aspart 30 in Type 2 Diabetes Mellitus When Failing on OADs
NCT ID: NCT00537277
Last Updated: 2014-12-08
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE4
161 participants
INTERVENTIONAL
2007-10-31
2009-01-31
Brief Summary
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This is a clinical trial investigating the effectiveness and the safety of using biphasic insulin aspart 30 both for initiation and intensification of insulin treatment in type 2 diabetes.
Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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BIAsp 30
Biphasic insulin aspart 30 administered once daily for 16 weeks. If HbA1c is higher than 7.0 % after 16 weeks of treatment, dose is increased to twice daily for another 16 weeks. If HbA1c is higher than 7.0 % after 32 weeks of treatment, dose is increased to three times daily until week 48 (end of trial).
biphasic insulin aspart
Treat-to-target dose titration scheme (dose individually adjusted), injected s.c. (under the skin)
Interventions
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biphasic insulin aspart
Treat-to-target dose titration scheme (dose individually adjusted), injected s.c. (under the skin)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* HbA1c: 7.5 - 11.0%
* An antidiabetic regimen that has been stable for at least 3 months prior to screening
* An antidiabetic regimen that includes a minimum of 2 oral anti-diabetic drugs (OADs) or 1 OAD plus evening or bedtime basal insulin
* OADs dosed at 50% or more of the maximum recommended dose
Exclusion Criteria
* Use of more than 60 units of insulin per day
* Morning time insulin administration
* Use of more than one insulin dose daily
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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Istanbul, , Turkey (Türkiye)
Countries
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Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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BIASP-1849
Identifier Type: -
Identifier Source: org_study_id