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Note: This record shows only the 20 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.
Register: ClinicalTrials.gov
Last refreshed on: 17 October 2012
Main ID:  NCT01275794
Date of registration: 11/01/2011
Primary sponsor: AstraZeneca
Public title: 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
Scientific title: Screening Epidemiological Program on Compensation Evaluation of DM Type 2 Patients on OAD Monotherapy and Physicians Satisfaction of Their Usage
Date of first enrolment: December 2010
Target sample size: 1849
Recruitment status: Completed
URL:  http://clinicaltrials.gov/show/NCT01275794
Study type:  Observational
Study design:  Observational Model: Case-Only, Time Perspective: Retrospective  
Countries of recruitment
Contacts
Key inclusion & exclusion criteria

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
Health Condition(s) or Problem(s) studied
Type 2 Diabetes
Intervention(s)
Primary Outcome(s)
To assess frequency of target levels of HbA1c = 7% in patients with T2D during OAD monotherapy [Time Frame: 1 visit within 4 month]
To assess levels of compensation of T2D by HbA1c levels in patients on OAD monotherapy [Time Frame: 1 visit within 4 month]
Secondary Outcome(s)
To assess fasting glycemia in patients with T2D on OAD monotherapy [Time Frame: 1 visit within 4 month]
To assess postprandial levels of glycemia in patients with T2D during OAD monotherapy [Time Frame: 1 visit within 4 month]
To compare the results of OAD monotherapy in different groups of patients [Time Frame: 1 visit within 4 month]
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]
Secondary ID(s)
NIS-CRU-ONG-2010/1
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Bristol-Myers Squibb
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