Safety and Efficacy of Biphasic Insulin Aspart 50 in Subjects With Type 2 Diabetes
NCT ID: NCT01650129
Last Updated: 2017-02-24
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
83 participants
INTERVENTIONAL
2000-12-13
2001-10-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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BIAsp
biphasic insulin aspart 50
Administered subcutaneously (s.c., under the skin) twice daily for 24 weeks. Injected immediately before breakfast and dinner
BHI
biphasic human insulin 50
Administered subcutaneously (s.c., under the skin) twice daily for 24 weeks. Injected 30 minutes before breakfast and dinner
Interventions
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biphasic insulin aspart 50
Administered subcutaneously (s.c., under the skin) twice daily for 24 weeks. Injected immediately before breakfast and dinner
biphasic human insulin 50
Administered subcutaneously (s.c., under the skin) twice daily for 24 weeks. Injected 30 minutes before breakfast and dinner
Eligibility Criteria
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Inclusion Criteria
* Subjects with insulin treated for at least 24 weeks
* HbA1c maximum 11.0%
* Body mass index (BMI) below 30.0 kg/m\^2
* Patients who have the skill of self-injection of insulin, and are able and willing to perform self-monitoring blood glucose (SMBG) and are able to take measures against hypoglycaemic episodes
Exclusion Criteria
* Subjects with proliferative retinopathy or preproliferative retinopathy diagnosed within the last 12 weeks, or receiving photocoagulation therapy within the last one year
* Impaired hepatic function
* Impaired renal function
* Cardiac diseases
* Uncontrolled hypertension
* Subjects with history of severe allergic or severe hypersensitive reactions
* Total daily insulin dose at least 100 IU
* Treatment with oral hypoglycaemic agentsvwithin the last 4 weeks
20 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
Tokyo, , Japan
Countries
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Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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BIASP-1352
Identifier Type: -
Identifier Source: org_study_id
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