Effect of Biphasic Insulin Aspart 50 on Blood Glucose Control in Subjects With Type 2 Diabetes
NCT ID: NCT00627445
Last Updated: 2014-10-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
441 participants
INTERVENTIONAL
2008-02-29
2009-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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BIAsp 50-50-30
Biphasic insulin aspart 50 administered before breakfast and lunch + biphasic insulin aspart 30 at dinner combined with metformin
biphasic insulin aspart 30
Treat-to-target dose titration scheme (dose adjusted individually), s.c. (under the skin) injection before dinner
metformin
Tablets, 500 - 2000 mg, once, twice or three times daily
biphasic insulin aspart 50
Treat-to-target dose titration scheme (dose adjusted individually), s.c. (under the skin) injection before breakfast and lunch
BIAsp 30-30
Biphasic insulin aspart 30 administered before breakfast and dinner combined with metformin
biphasic insulin aspart 30
Treat-to-target dose titration scheme (dose adjusted individually), s.c. (under the skin) injection before dinner
metformin
Tablets, 500 - 2000 mg, once, twice or three times daily
Interventions
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biphasic insulin aspart 30
Treat-to-target dose titration scheme (dose adjusted individually), s.c. (under the skin) injection before dinner
metformin
Tablets, 500 - 2000 mg, once, twice or three times daily
biphasic insulin aspart 50
Treat-to-target dose titration scheme (dose adjusted individually), s.c. (under the skin) injection before breakfast and lunch
Eligibility Criteria
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Inclusion Criteria
* Currently treated with premix human insulin twice daily with or without oral antidiabetic drugs for at least 3 months
* HbA1c (Glycosylated Haemoglobin A1c) between 7.5% - 12.0% (both inclusive)
* FPG (Fasting Plasma Glucose) higher than 7.0 mmol/L
* BMI (Body Mass Index) 23-40 kg/sq.m (both inclusive)
Exclusion Criteria
* Systemic use of TZDs (thiazolidinediones) for more than 1 month within 6 months prior to this trial
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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Beijing, Beijing Municipality, China
Countries
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Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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BIASP-1858
Identifier Type: -
Identifier Source: org_study_id
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