Comparison of Two Biphasic Insulin Aspart Treatments in Subjects With Type 2 Diabetes
NCT ID: NCT01520753
Last Updated: 2017-01-04
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
16 participants
INTERVENTIONAL
1999-03-31
1999-06-30
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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BIAsp 70
biphasic insulin aspart 70
Administered subcutaneously (s.c., under the skin) at breakfast, lunch and dinner
BIAsp 70 + BIAsp 50
biphasic insulin aspart 70
Administered subcutaneously (s.c., under the skin) at breakfast and lunch
biphasic insulin aspart 50
Administered subcutaneously (s.c., under the skin) at dinner
Interventions
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biphasic insulin aspart 70
Administered subcutaneously (s.c., under the skin) at breakfast, lunch and dinner
biphasic insulin aspart 70
Administered subcutaneously (s.c., under the skin) at breakfast and lunch
biphasic insulin aspart 50
Administered subcutaneously (s.c., under the skin) at dinner
Eligibility Criteria
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Inclusion Criteria
* Duration of diabetes for longer than 12 months
* Body mass index (BMI) below 35.0 kg/m\^2
* HbA1c below 11.0 %
* Treatment with BHI (biphasic human insulin) 20 or 30 twice daily for at least three months and in the last month as sole anti-diabetic treatment (i.e., no additional oral hypoglycaemic medication or daily use of short-acting insulin supplement)
Exclusion Criteria
* History of drug or alcohol dependence
* Impaired hepatic function
* Impaired renal function
* Cardiac disease
* Proliferative retinopathy
* Recurrent severe hypoglycaemia or advanced neuropathy
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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Ejskjaer N, Rasmussen M, Kamp N, Lindholm A, Christiansen JS. Comparison of thrice daily 'high' vs. 'medium' premixed insulin aspart with respect to evening and overnight glycaemic control in patients with type 2 diabetes. Diabetes Obes Metab. 2003 Nov;5(6):438-45. doi: 10.1046/j.1463-1326.2003.00299.x.
Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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BIASP-1074
Identifier Type: -
Identifier Source: org_study_id
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