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

June 1, 2012 updated by: AstraZeneca

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

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

1849

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • 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
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Clinical practice

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To assess levels of compensation of T2D by HbA1c levels in patients on OAD monotherapy
Time Frame: 1 visit within 4 month
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
1 visit within 4 month

Secondary Outcome Measures

Outcome Measure
Time Frame
To assess fasting glycemia in patients with T2D on OAD monotherapy
Time Frame: 1 visit within 4 month
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
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
1 visit within 4 month
To compare the results of OAD monotherapy in different groups of patients
Time Frame: 1 visit within 4 month
1 visit within 4 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Collaborators

Bristol-Myers Squibb

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2010

Primary Completion (ACTUAL)

March 1, 2011

Study Completion (ACTUAL)

March 1, 2011

Study Registration Dates

First Submitted

January 11, 2011

First Submitted That Met QC Criteria

January 11, 2011

First Posted (ESTIMATE)

January 12, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

June 4, 2012

Last Update Submitted That Met QC Criteria

June 1, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIS-CRU-ONG-2010/1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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