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:
AstraZeneca
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
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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
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 Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on May 21, 2013