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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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19 February 2015 |
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Main ID: |
NCT01275794 |
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Date of registration:
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11/01/2011 |
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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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Screening Epidemiological Program on Compensation Evaluation of Diabetes Mellitus Type 2 (DMT2) Patients on Oral Anti-diabetic (OAD) Monotherapy and Physicians Satisfaction of Their Usage
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Scientific title:
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Screening Epidemiological Program on Compensation Evaluation of DM Type 2 Patients on OAD Monotherapy and Physicians Satisfaction of Their Usage |
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Date of first enrolment:
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December 2010 |
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Target sample size:
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1849 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01275794 |
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Study type:
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Observational |
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Study design:
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Observational Model: Case-Only, Time Perspective: Retrospective
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Phase:
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N/A
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Countries of recruitment
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Russian Federation
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Contacts
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Name:
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Alexey Stepanov |
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Address:
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Telephone:
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Email:
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Affiliation:
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AstraZeneca |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients have an established diagnosis of T2D
- Experience of therapy with one OAD during the from 6 months to 5 years before the
registration in the Program
Exclusion Criteria:
- Experience of therapy with two or more OADs and/or insulin therapy and/or incretin
mimetics (exenatide) at any time before registration in the Program
- Absence of changes in HbAc1 level during the last year before registration in the
Program
Age minimum:
35 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Type 2 Diabetes
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Primary Outcome(s)
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To assess frequency of target levels of HbA1c = 7% in patients with T2D during OAD monotherapy
[Time Frame: 1 visit within 4 month]
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To assess levels of compensation of T2D by HbA1c levels in patients on OAD monotherapy
[Time Frame: 1 visit within 4 month]
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Secondary Outcome(s)
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To assess postprandial levels of glycemia in patients with T2D during OAD monotherapy
[Time Frame: 1 visit within 4 month]
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To evaluate the physicians' satisfaction with the results of OAD monotherapy in patients with Typ 2 Diabetes (T2D)
[Time Frame: 1 visit within 4 month]
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To assess fasting glycemia in patients with T2D on OAD monotherapy
[Time Frame: 1 visit within 4 month]
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To compare the results of OAD monotherapy in different groups of patients
[Time Frame: 1 visit within 4 month]
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Secondary ID(s)
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NIS-CRU-ONG-2010/1
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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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