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

This study has been completed.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01275794
First received: January 11, 2011
Last updated: June 1, 2012
Last verified: June 2012

January 11, 2011
June 1, 2012
December 2010
March 2011   (final data collection date for primary outcome measure)
  • To assess levels of compensation of T2D by HbA1c levels in patients on OAD monotherapy [ Time Frame: 1 visit within 4 month ] [ Designated as safety issue: No ]
  • To assess frequency of target levels of HbA1c ≤ 7% in patients with T2D during OAD monotherapy [ Time Frame: 1 visit within 4 month ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01275794 on ClinicalTrials.gov Archive Site
  • To assess fasting glycemia in patients with T2D on OAD monotherapy [ Time Frame: 1 visit within 4 month ] [ Designated as safety issue: No ]
  • To assess postprandial levels of glycemia in patients with T2D during OAD monotherapy [ Time Frame: 1 visit within 4 month ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • To compare the results of OAD monotherapy in different groups of patients [ Time Frame: 1 visit within 4 month ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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
Screening Epidemiological Program on Compensation Evaluation of DM Type 2 Patients on OAD Monotherapy and Physicians Satisfaction of Their Usage

The purpose of the study is assessment of glycemic control and physicians satisfaction with results of DM2 OAD monotherapy

Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Retrospective
Not Provided
Not Provided
Non-Probability Sample

Clinical practice

Type 2 Diabetes
Not Provided
1
Patients have an established diagnosis of T2D, Age 35 years and more, Experience of therapy with one OAD during the from 6 months to 5 years before the registration in the Program
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1849
March 2011
March 2011   (final data collection date for primary outcome measure)

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
Both
35 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Russian Federation
 
NCT01275794
NIS-CRU-ONG-2010/1
No
AstraZeneca
AstraZeneca
Bristol-Myers Squibb
Study Director: Alexey Stepanov AstraZeneca
AstraZeneca
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP