Comparison of the Pharmacodynamics and Pharmacokinetics of Biphasic Insulin Aspart 30, 50, 70 and Insulin Aspart in Subjects With Type 1 Diabetes
NCT ID: NCT01536028
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
PHASE1
32 participants
INTERVENTIONAL
2006-04-30
2006-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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BIAsp 30
biphasic insulin aspart 70
A single dose administrated subcutaneously (s.c., under the skin) on four separate dosing visits in random order with a washout of 1-2 weeks in-between
insulin aspart
A single dose administrated subcutaneously (s.c., under the skin) on four separate dosing visits in random order with a washout of 1-2 weeks in-between
biphasic insulin aspart 30
A single dose administrated subcutaneously (s.c., under the skin) on four separate dosing visits in random order with a washout of 1-2 weeks in-between
biphasic insulin aspart 50
A single dose administrated subcutaneously (s.c., under the skin) on four separate dosing visits in random order with a washout of 1-2 weeks in-between
BIAsp 50
biphasic insulin aspart 70
A single dose administrated subcutaneously (s.c., under the skin) on four separate dosing visits in random order with a washout of 1-2 weeks in-between
insulin aspart
A single dose administrated subcutaneously (s.c., under the skin) on four separate dosing visits in random order with a washout of 1-2 weeks in-between
biphasic insulin aspart 30
A single dose administrated subcutaneously (s.c., under the skin) on four separate dosing visits in random order with a washout of 1-2 weeks in-between
biphasic insulin aspart 50
A single dose administrated subcutaneously (s.c., under the skin) on four separate dosing visits in random order with a washout of 1-2 weeks in-between
BIAsp 70
biphasic insulin aspart 70
A single dose administrated subcutaneously (s.c., under the skin) on four separate dosing visits in random order with a washout of 1-2 weeks in-between
insulin aspart
A single dose administrated subcutaneously (s.c., under the skin) on four separate dosing visits in random order with a washout of 1-2 weeks in-between
biphasic insulin aspart 30
A single dose administrated subcutaneously (s.c., under the skin) on four separate dosing visits in random order with a washout of 1-2 weeks in-between
biphasic insulin aspart 50
A single dose administrated subcutaneously (s.c., under the skin) on four separate dosing visits in random order with a washout of 1-2 weeks in-between
IAsp
biphasic insulin aspart 70
A single dose administrated subcutaneously (s.c., under the skin) on four separate dosing visits in random order with a washout of 1-2 weeks in-between
insulin aspart
A single dose administrated subcutaneously (s.c., under the skin) on four separate dosing visits in random order with a washout of 1-2 weeks in-between
biphasic insulin aspart 30
A single dose administrated subcutaneously (s.c., under the skin) on four separate dosing visits in random order with a washout of 1-2 weeks in-between
biphasic insulin aspart 50
A single dose administrated subcutaneously (s.c., under the skin) on four separate dosing visits in random order with a washout of 1-2 weeks in-between
Interventions
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biphasic insulin aspart 70
A single dose administrated subcutaneously (s.c., under the skin) on four separate dosing visits in random order with a washout of 1-2 weeks in-between
insulin aspart
A single dose administrated subcutaneously (s.c., under the skin) on four separate dosing visits in random order with a washout of 1-2 weeks in-between
biphasic insulin aspart 30
A single dose administrated subcutaneously (s.c., under the skin) on four separate dosing visits in random order with a washout of 1-2 weeks in-between
biphasic insulin aspart 50
A single dose administrated subcutaneously (s.c., under the skin) on four separate dosing visits in random order with a washout of 1-2 weeks in-between
Eligibility Criteria
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Inclusion Criteria
* Serum C-peptide maximum 0.4 ng/mL
* Current basal bolus treatment with soluble human insulin, insulin lispro, insulin glulisine, NPH insulin, insulin detemir or insulin glargine
* BMI (Body Mass Index) maximum 32 kg/m\^2
* HbA1c (glycosylated haemoglobin) maximum 9% based on analysis from central laboratory
* Non-smoker
Exclusion Criteria
* Total daily insulin dose at least 1.8 U/kg/day
* Current treatment with IAsp (insulin aspart) products
* A history of drug or alcohol abuse within the last 5 years
* Impaired hepatic function
* Impaired renal function
* Cardiac problems
* Severe, uncontrolled hypertension
18 Years
55 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
Neuss, , Germany
Countries
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References
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Heise T, Eckers U, Kanc K, Nielsen JN, Nosek L. The pharmacokinetic and pharmacodynamic properties of different formulations of biphasic insulin aspart: a randomized, glucose clamp, crossover study. Diabetes Technol Ther. 2008 Dec;10(6):479-85. doi: 10.1089/dia.2008.0019.
Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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2005-004965-40
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
BIASP-1746
Identifier Type: -
Identifier Source: org_study_id
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