Investigating Efficacy and Safety of Biphasic Insulin Aspart 50 Twice Daily Versus Biphasic Human Insulin 50 Twice Daily Both in Combination With Metformin in Chinese Subjects With Type 2 Diabetes Mellitus
NCT ID: NCT01892020
Last Updated: 2015-07-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
161 participants
INTERVENTIONAL
2013-06-30
2014-05-31
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
NONE
Study Groups
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Treatment sequence 1 (Group A)
Group A will receive BIAsp 50 BID during the first 4 weeks (treatment period 1) then switch to BHI 50 BID for further 4 weeks (treatment period 2)
biphasic insulin aspart 50
Administered subcutaneously (s.c., under the skin) twice daily (BID). Dose individually adjusted. All subjects will receive metformin in combination with trial insulin.
biphasic human insulin 50
Administered subcutaneously (s.c., under the skin) twice daily (BID). Dose individually adjusted. All subjects will receive metformin in combination with trial insulin.
Treatment sequence 2 (Group B)
Group B will receive BHI 50 BID during the first 4 weeks (treatment period 1), then switch to BIAsp 50 BID for further 4 weeks (treatment period 2)
biphasic insulin aspart 50
Administered subcutaneously (s.c., under the skin) twice daily (BID). Dose individually adjusted. All subjects will receive metformin in combination with trial insulin.
biphasic human insulin 50
Administered subcutaneously (s.c., under the skin) twice daily (BID). Dose individually adjusted. All subjects will receive metformin in combination with trial insulin.
Interventions
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biphasic insulin aspart 50
Administered subcutaneously (s.c., under the skin) twice daily (BID). Dose individually adjusted. All subjects will receive metformin in combination with trial insulin.
biphasic human insulin 50
Administered subcutaneously (s.c., under the skin) twice daily (BID). Dose individually adjusted. All subjects will receive metformin in combination with trial insulin.
Eligibility Criteria
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Inclusion Criteria
* Currently treated with premixed human insulin 50 BID for at least 3 months prior to screening visit (Visit 1)
* Currently treated with unchanged total daily dose of at least 1500 mg metformin or maximum tolerated dose at least 1000 mg/day metformin for at least 2 months prior to screening visit
* Glycosylated haemoglobin (HbA1c) 7.0% and 9.0% (both inclusive) (central laboratory)
Exclusion Criteria
* Previous use of any insulin other than premixed human insulin 50 BID within 3 months prior to Visit 1
* Previous use of insulin intensification treatment (premixed insulin thrice daily, basal bolus regimen, and continuous subcutaneous insulin infusion (CSII)) for more than 14 days
18 Years
80 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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U1111-1137-2342
Identifier Type: OTHER
Identifier Source: secondary_id
BIASP-4058
Identifier Type: -
Identifier Source: org_study_id
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