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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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01275794
First Posted: January 12, 2011
Last Update Posted: June 4, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
AstraZeneca
  Purpose
The purpose of the study is assessment of glycemic control and physicians satisfaction with results of DM2 OAD monotherapy

Condition
Type 2 Diabetes

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Screening Epidemiological Program on Compensation Evaluation of DM Type 2 Patients on OAD Monotherapy and Physicians Satisfaction of Their Usage

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • To assess levels of compensation of T2D by HbA1c levels in patients on OAD monotherapy [ Time Frame: 1 visit within 4 month ]
  • To assess frequency of target levels of HbA1c ≤ 7% in patients with T2D during OAD monotherapy [ Time Frame: 1 visit within 4 month ]

Secondary Outcome Measures:
  • 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 evaluate the physicians' satisfaction with the results of OAD monotherapy in patients with Typ 2 Diabetes (T2D) [ 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 ]

Enrollment: 1849
Study Start Date: December 2010
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   35 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Clinical practice
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01275794


Locations
Russian Federation
Research Site
Arkhangelsk, Russian Federation
Research Site
Astrakhan, Russian Federation
Research Site
Barnaul, Russian Federation
Research Site
Chelyabinsk, Russian Federation
Research Site
Izhevsk, Russian Federation
Research Site
Joshkar-Ola, Russian Federation
Research Site
Kazan, Russian Federation
Research Site
Khemerovo, Russian Federation
Research Site
Kirov, Russian Federation
Research Site
Kurgan, Russian Federation
Research Site
Moscow, Russian Federation
Research Site
Nizhni Novgorod, Russian Federation
Research Site
Perm, Russian Federation
Research Site
Petrozavodsk, Russian Federation
Research Site
Rostov-on-Don, Russian Federation
Research Site
Samara, Russian Federation
Research Site
Seversk, Russian Federation
Research Site
Smolensk, Russian Federation
Research Site
St-Peterburg, Russian Federation
Research Site
Tomsk, Russian Federation
Research Site
Tyumen, Russian Federation
Research Site
Ufa, Russian Federation
Research Site
Yaroslavl, Russian Federation
Sponsors and Collaborators
AstraZeneca
Bristol-Myers Squibb
Investigators
Study Director: Alexey Stepanov AstraZeneca
  More Information

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01275794     History of Changes
Other Study ID Numbers: NIS-CRU-ONG-2010/1
First Submitted: January 11, 2011
First Posted: January 12, 2011
Last Update Posted: June 4, 2012
Last Verified: June 2012

Keywords provided by AstraZeneca:
Type 2 Diabetes

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases