Comparison of Pharmacodynamics and Pharmacokinetics of Biphasic Insulin Aspart 50 to Biphasic Insulin Aspart 70 in Type 2 Diabetes
NCT ID: NCT00612599
Last Updated: 2017-01-06
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
75 participants
INTERVENTIONAL
2003-09-30
2004-06-30
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
Interventions
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biphasic insulin aspart
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Stable glycaemic control, having been on the existing treatment for at least 1 month
* BMI between 23-28 kg/m2 (non-obese) or between 30-35 kg/m2 (obese)
* HbA1c below 9.0%
* Willing to eat three main meals per day during the trial period and perform Self-Monitoring of Blood Glucose (SBGM) regularly
Exclusion Criteria
* Blood donation within the last 3 months
* Currently being treated with systemic corticosteroids, Mono Amine Oxidase (MAO) inhibitors, beta-adrenergic blocking agents, anabolic steroids or any other drug affecting blood glucose
* Severe, uncontrolled hypertension
* Proliferative retinopathy or maculopathy requiring acute treatment
* Pregnancy, breast-feeding, intention of becoming pregnant or judged not to be using adequate contraceptive measures (for women of childbearing potential only contraceptive pills and intra uterine devices are considered as adequate contraceptive methods)
30 Years
70 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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Parkner T, Dyrskog SE, Laursen T, Chen JW, Mouritzen U, Brondsted L, Hermansen K, Lauritzen T, Christiansen JS. Obesity does not influence the unique pharmacological properties of different biphasic insulin aspart preparations in patients with type 2 diabetes. Diabetes Obes Metab. 2010 May;12(5):414-20. doi: 10.1111/j.1463-1326.2009.01178.x.
Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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BIASP-1526
Identifier Type: -
Identifier Source: org_study_id
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