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
  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

Resource links provided by NLM:


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 ] [ 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 ]

Secondary Outcome Measures:
  • 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 ]

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

Ages Eligible for Study:   35 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01275794     History of Changes
Other Study ID Numbers: NIS-CRU-ONG-2010/1
Study First Received: January 11, 2011
Last Updated: June 1, 2012
Health Authority: Russia: Ethics Committee

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

ClinicalTrials.gov processed this record on October 19, 2014