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

Type 2 Diabetes Clinical Trial

Official title:

Screening Epidemiological Program on Compensation Evaluation of DM Type 2 Patients on OAD Monotherapy and Physicians Satisfaction of Their Usage

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01275794
• Other study ID #: NIS-CRU-ONG-2010/1
• Status: Completed
• Phase: N/A
• First received: January 11, 2011
• Last updated: June 1, 2012
• Start date: December 2010
• Est. completion date: March 2011

Study information

• Verified date: June 2012
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Ethics Committee
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1849
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Locations

Country	Name	City	State
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

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	Bristol-Myers Squibb

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess levels of compensation of T2D by HbA1c levels in patients on OAD monotherapy		1 visit within 4 month	No
Primary	To assess frequency of target levels of HbA1c = 7% in patients with T2D during OAD monotherapy		1 visit within 4 month	No
Secondary	To assess fasting glycemia in patients with T2D on OAD monotherapy		1 visit within 4 month	No
Secondary	To assess postprandial levels of glycemia in patients with T2D during OAD monotherapy		1 visit within 4 month	No
Secondary	To evaluate the physicians' satisfaction with the results of OAD monotherapy in patients with Typ 2 Diabetes (T2D)		1 visit within 4 month	No
Secondary	To compare the results of OAD monotherapy in different groups of patients		1 visit within 4 month	No