Glycaemic Control of Biphasic Insulin Aspart 70 and 30 in Subjects With Type 2 Diabetes
NCT ID: NCT01526980
Last Updated: 2017-01-05
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
PHASE2
31 participants
INTERVENTIONAL
2002-05-31
2002-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Treatment period 1
biphasic insulin aspart 30
Administrated subcutaneously (s.c., under the skin) once daily before dinner for 30 days in each treatment period
biphasic insulin aspart 70
Administrated subcutaneously (s.c., under the skin) twice daily before breakfast and lunch for 30 days in each treatment period
biphasic human insulin 30
Administrated subcutaneously (s.c., under the skin) twice daily before breakfast and dinner for 30 days in each treatment period
Treatment period 2
biphasic insulin aspart 30
Administrated subcutaneously (s.c., under the skin) once daily before dinner for 30 days in each treatment period
biphasic insulin aspart 70
Administrated subcutaneously (s.c., under the skin) twice daily before breakfast and lunch for 30 days in each treatment period
biphasic human insulin 30
Administrated subcutaneously (s.c., under the skin) twice daily before breakfast and dinner for 30 days in each treatment period
Interventions
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biphasic insulin aspart 30
Administrated subcutaneously (s.c., under the skin) once daily before dinner for 30 days in each treatment period
biphasic insulin aspart 70
Administrated subcutaneously (s.c., under the skin) twice daily before breakfast and lunch for 30 days in each treatment period
biphasic human insulin 30
Administrated subcutaneously (s.c., under the skin) twice daily before breakfast and dinner for 30 days in each treatment period
Eligibility Criteria
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Inclusion Criteria
* Treatment with BHI (biphasic human insulin) 30 twice daily for at least three months
* HbA1c maximum 10.0%
* BMI (Body Mass Index) maximum 35.0 kg/m2
* Able and willing to perform self-blood glucose monitoring (SBGM)
Exclusion Criteria
* Total daily insulin dose minimum 2.0 U/(kg·day)
* A history of drug abuse or alcohol dependence within the last 5 years
* Impaired hepatic function
* Impaired renal function
* Cardiac disease
* Severe, uncontrolled hypertension
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
Newcastle, , United Kingdom
Countries
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References
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Dashora U, Ashwell SG, Home PD. An exploratory study of the effect of using high-mix biphasic insulin aspart in people with type 2 diabetes. Diabetes Obes Metab. 2009 Jul;11(7):680-7. doi: 10.1111/j.1463-1326.2008.01024.x.
Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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BIASP-1319
Identifier Type: -
Identifier Source: org_study_id
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