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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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12 December 2020 |
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Main ID: |
NCT01696266 |
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Date of registration:
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26/09/2012 |
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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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An International Survey on Hypoglycaemia Among Insulin-treated Patients With Diabetes
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Scientific title:
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An International Survey on Hypoglycaemia Among Insulin-treated Patients With Diabetes |
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Date of first enrolment:
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September 5, 2012 |
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Target sample size:
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29304 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01696266 |
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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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Argentina
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Austria
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Bulgaria
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Canada
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Croatia
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Czech Republic
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Czechia
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Denmark
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Finland
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Germany
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Hungary
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India
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Israel
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Lebanon
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Malaysia
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Mexico
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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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Saudi Arabia
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Serbia
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Slovakia
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Slovenia
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Sweden
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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:
- Patients with Type 1 or Type 2 diabetes mellitus treated with insulin for more than 12
months
- Patients giving informed consent to participate in the survey
Exclusion Criteria:
- Non-ambulatory patients
- Illiterate patients and patients otherwise unable to complete a written survey
Age minimum:
N/A
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Diabetes
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Diabetes Mellitus, Type 2
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Diabetes Mellitus, Type 1
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Intervention(s)
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Other: No treatment given
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Primary Outcome(s)
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Incidence of any hypoglycaemic event
[Time Frame: In the 4 weeks prior to and following the baseline visit (Week 0)]
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Secondary Outcome(s)
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Incidence of probable symptomatic hypoglycaemic events
[Time Frame: In the 4 weeks prior to and following the baseline visit]
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Incidence of all severe hypoglycaemic events
[Time Frame: In the 6 months prior to and 4 weeks following the baseline visit]
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Incidence of hypoglycaemic events requiring hospital admission
[Time Frame: In the 6 months prior to and 4 weeks following the baseline visit]
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Difference in the reported incidence rates of any hypoglycaemia
[Time Frame: In the 4 weeks prior to (Part 1) versus following (Part 2) the baseline visit]
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Secondary ID(s)
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INS-4019
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U1111-1132-1910
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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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