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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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13 November 2023 |
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Main ID: |
NCT00712478 |
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Date of registration:
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30/06/2008 |
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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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Observational Study Describing Conditions for Intensification of Insulin Therapy in Type 2 Diabetes
INTENSE3MIX |
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Scientific title:
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Observational Study on Efficacy of Intensification of Insulin Therapy to at Least 3 Daily Injections in Type 2 Diabetes |
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Date of first enrolment:
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September 2007 |
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Target sample size:
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114 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT00712478 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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France
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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 patients
- Treatment with two insulin daily injections and needing insulin intensification
regimen to at least three daily injections
- HbA1c greater than or equal to 8.0%
Exclusion Criteria:
- Patients not performing glycaemia self-measurements
- Secondary diabetes
- Requirement of or use of an insulin pump
- Treatment with corticoids
Age minimum:
40 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: insulin
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Primary Outcome(s)
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Evaluate improvement of diabetes control with fasting glycemia and after diner glycemia measurements
[Time Frame: After 3 months]
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Secondary Outcome(s)
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Evaluate improvement of diabetes control with fasting glycemia and after diner glycemia measurements
[Time Frame: After first 2 months]
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Secondary ID(s)
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BIASP-1866
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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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