Pharmacokinetics of Biphasic Insulin Aspart 30 and 70 in Subjects With Type 1 Diabetes
NCT ID: NCT01524809
Last Updated: 2017-01-05
Study Results
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Basic Information
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COMPLETED
PHASE1
26 participants
INTERVENTIONAL
2001-01-31
2001-06-30
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
DOUBLE
Study Groups
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Treatment period 1
biphasic insulin aspart 30
Dose individually adjusted. Administrated subcutaneously (s.c., under the skin) three times a day for 15 days in each treatment period. A wash-out period of 2-8 weeks will take place between treatment periods.
biphasic insulin aspart 70
Dose individually adjusted. Administrated subcutaneously (s.c., under the skin) three times a day for 15 days in each treatment period. A wash-out period of 2-8 weeks will take place between treatment periods.
Treatment period 2
biphasic insulin aspart 30
Dose individually adjusted. Administrated subcutaneously (s.c., under the skin) three times a day for 15 days in each treatment period. A wash-out period of 2-8 weeks will take place between treatment periods.
biphasic insulin aspart 70
Dose individually adjusted. Administrated subcutaneously (s.c., under the skin) three times a day for 15 days in each treatment period. A wash-out period of 2-8 weeks will take place between treatment periods.
Interventions
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biphasic insulin aspart 30
Dose individually adjusted. Administrated subcutaneously (s.c., under the skin) three times a day for 15 days in each treatment period. A wash-out period of 2-8 weeks will take place between treatment periods.
biphasic insulin aspart 70
Dose individually adjusted. Administrated subcutaneously (s.c., under the skin) three times a day for 15 days in each treatment period. A wash-out period of 2-8 weeks will take place between treatment periods.
Eligibility Criteria
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Inclusion Criteria
* Currently on a multiple dose insulin regimen
* HbA1c maximum 12.0%
* BMI (body mass index) below 35 kg/m\^2
* Able and willing to perform self-blood glucose monitoring (SBGM)
Exclusion Criteria
* The receipt of any investigational drug within the last 30 days prior to this trial
* Total daily insulin dose at least 1.8 U/kg
* A history of drug abuse or alcohol dependence within the last 5 years
* Impaired hepatic function
* Impaired renal function
* Blood donation within the last nine weeks or haemoglobin below the lower reference limit according to the local laboratory
* 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
Århus C, , Denmark
Countries
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References
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Chen JW, Lauritzen T, Christiansen JJ, Jensen LH, Clausen WH, Christiansen JS. Pharmacokinetic profiles of biphasic insulin aspart 30/70 and 70/30 in patients with Type 1 diabetes: a randomized double-blinded crossover study. Diabet Med. 2005 Mar;22(3):273-7. doi: 10.1111/j.1464-5491.2004.01404.x.
Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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BIASP-1317
Identifier Type: -
Identifier Source: org_study_id
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