Comparison of Single Dose and Steady State Pharmacodynamics of Biphasic Insulin Aspart 30 and 70 in Subjects With Type 1 Diabetes
NCT ID: NCT01526941
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
PHASE1
27 participants
INTERVENTIONAL
2001-05-31
2001-07-31
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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Treatment period 1
biphasic insulin aspart 30
Dose individually adjusted. Administered subcutaneously (s.c., under the skin) three times a day for 1 week in each treatment period. A wash-out period of 2-6 weeks will take place between treatment periods
biphasic insulin aspart 70
Dose individually adjusted. Administered subcutaneously (s.c., under the skin) three times a day for 1 week in each treatment period. A wash-out period of 2-6 weeks will take place between treatment periods
Treatment period 2
biphasic insulin aspart 30
Dose individually adjusted. Administered subcutaneously (s.c., under the skin) three times a day for 1 week in each treatment period. A wash-out period of 2-6 weeks will take place between treatment periods
biphasic insulin aspart 70
Dose individually adjusted. Administered subcutaneously (s.c., under the skin) three times a day for 1 week in each treatment period. A wash-out period of 2-6 weeks will take place between treatment periods
Interventions
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biphasic insulin aspart 30
Dose individually adjusted. Administered subcutaneously (s.c., under the skin) three times a day for 1 week in each treatment period. A wash-out period of 2-6 weeks will take place between treatment periods
biphasic insulin aspart 70
Dose individually adjusted. Administered subcutaneously (s.c., under the skin) three times a day for 1 week in each treatment period. A wash-out period of 2-6 weeks will take place between treatment periods
Eligibility Criteria
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Inclusion Criteria
* Currently on basal bolus treatment with soluble human insulin, Lispro and NPH insulin or Lantus. NPH insulin may be administered once or twice daily
* BMI (Body Mass Index) maximum 35 kg/m\^2
* Able and willing to perform self-blood glucose monitoring
Exclusion Criteria
* Total daily insulin dose at least 1.8 U/kg/day
* Currently being treated with insulin aspart products
* A history of drug abuse or alcohol dependence within the last 5 years
* Impaired hepatic function
* Impaired renal function
* Blood donation (exceeding 500 ml) within the last nine weeks or haemoglobin below the lower reference limit according to the local laboratory
* Cardiac problems
* 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
Neuss, , Germany
Countries
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References
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Bott S, Tusek C, Heinemann L, Friberg HH, Heise T. The pharmacokinetic and pharmacodynamic properties of biphasic insulin Aspart 70 (BIAsp 70) are significantly different from those of biphasic insulin Aspart 30 (BIAsp 30). Exp Clin Endocrinol Diabetes. 2005 Oct;113(9):545-50. doi: 10.1055/s-2005-872852.
Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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BIASP-1318
Identifier Type: -
Identifier Source: org_study_id
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