Clinical trial NCT01275794: 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
Official title: Screening Epidemiological Program on Compensation Evaluation of DM Type 2 Patients on OAD Monotherapy and Physicians Satisfaction of Their Usage
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes
Keywords: Type 2 Diabetes
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Bristol-Myers Squibb
First posted: 2011-01-12
Enrollment: 1849
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Clinical practice

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


Eligibility 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

Primary outcomes:
measure: To assess levels of compensation of T2D by HbA1c levels in patients on OAD monotherapy
timeFrame: 1 visit within 4 month
measure: To assess frequency of target levels of HbA1c ≤ 7% in patients with T2D during OAD monotherapy
timeFrame: 1 visit within 4 month
Secondary outcomes:
measure: To assess fasting glycemia in patients with T2D on OAD monotherapy
timeFrame: 1 visit within 4 month
measure: To assess postprandial levels of glycemia in patients with T2D during OAD monotherapy
timeFrame: 1 visit within 4 month
measure: To evaluate the physicians' satisfaction with the results of OAD monotherapy in patients with Typ 2 Diabetes (T2D)
timeFrame: 1 visit within 4 month
measure: To compare the results of OAD monotherapy in different groups of patients
timeFrame: 1 visit within 4 month
Other outcomes:
Locations:
city: Arkhangelsk
country: Russian Federation
facility: Research Site
city: Astrakhan
country: Russian Federation
facility: Research Site
city: Barnaul
country: Russian Federation
facility: Research Site
city: Chelyabinsk
country: Russian Federation
facility: Research Site
city: Izhevsk
country: Russian Federation
facility: Research Site
city: Joshkar-Ola
country: Russian Federation
facility: Research Site
city: Kazan
country: Russian Federation
facility: Research Site
city: Khemerovo
country: Russian Federation
facility: Research Site
city: Kirov
country: Russian Federation
facility: Research Site
city: Kurgan
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Nizhni Novgorod
country: Russian Federation
facility: Research Site
city: Perm
country: Russian Federation
facility: Research Site
city: Petrozavodsk
country: Russian Federation
facility: Research Site
city: Rostov-on-Don
country: Russian Federation
facility: Research Site
city: Samara
country: Russian Federation
facility: Research Site
city: Seversk
country: Russian Federation
facility: Research Site
city: Smolensk
country: Russian Federation
facility: Research Site
city: St-Peterburg
country: Russian Federation
facility: Research Site
city: Tomsk
country: Russian Federation
facility: Research Site
city: Tyumen
country: Russian Federation
facility: Research Site
city: Ufa
country: Russian Federation
facility: Research Site
city: Yaroslavl
country: Russian Federation
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Alexey Stepanov
role: STUDY_DIRECTOR
References: