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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT00184574 |
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Date of registration:
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12/09/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Comparison of Biphasic Insulin Aspart 70/30, 50/50, and 30/70 in Subjects With Type 2 Diabetes
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Scientific title:
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Comparison of the Effect on Glycemic Control of Biphasic Insulin Aspart 70/30, Biphasic Insulin Aspart 50/50, and Biphasic Insulin Aspart 30/70 All in Combination With Metformin in Subjects With Type 2 Diabetes (the INTENSIMIX Trial). |
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Date of first enrolment:
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April 2005 |
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Target sample size:
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603 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00184574 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 3
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Countries of recruitment
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Austria
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Belgium
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Bulgaria
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Czech Republic
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Denmark
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France
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Germany
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Hungary
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Italy
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Netherlands
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Poland
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Romania
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Russian Federation
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Slovenia
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Spain
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Switzerland
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Turkey
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United Kingdom
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Contacts
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Name:
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Global Clinical Registry (GCR, 1452) |
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Address:
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Telephone:
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Email:
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Affiliation:
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Novo Nordisk A/S |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Type 2 diabetes
- Currently treated with insulin
- Currently treated with Metformin
- HbA1c: 7.5-12.0%
Exclusion Criteria:
- Body Mass Index (BMI) < 25.0 or > 40.0 kg/m2
- Metformin contraindications according to local practice
- TZDs within 6 months prior to randomisation
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Diabetes Mellitus, Type 2
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Diabetes
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Intervention(s)
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Drug: metformin
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Drug: biphasic insulin aspart
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Primary Outcome(s)
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HbA1c
[Time Frame: after 36 weeks]
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Secondary Outcome(s)
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Safety variables
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8-point plasma glucose profiles
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Other glycemic variables
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Secondary ID(s)
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BIASP-1440
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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