Type 2 DiabetesNCT01275794
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
An observational study of Type 2 Diabetes, run by AstraZeneca at 23 sites in Russia.
Trial summary
The purpose of the study is assessment of glycemic control and physicians satisfaction with results of DM2 OAD monotherapy Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Type 2 Diabetes
- How many people
- 1,849 participants
- Where
- 23 sitesRussia
- Study dates
- Dec 2010to Mar 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Clinical practice
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
Russia23 sites
Research Site
Arkhangelsk
Research Site
Astrakhan
Research Site
Barnaul
Research Site
Chelyabinsk
Research Site
Izhevsk
Research Site
Kazan'
Research Site
Khemerovo
Research Site
Kirov
Research Site
Kurgan
Research Site
Moscow
Research Site
Nizhny Novgorod
Research Site
Perm
Research Site
Petrozavodsk
Research Site
Rostov-on-Don
Research Site
Samara
Research Site
Seversk
Research Site
Smolensk
Research Site
St-Peterburg
Research Site
Tomsk
Research Site
Tyumen
Research Site
Ufa
Research Site
Yaroslavl
Research Site
Yoshkar-Ola
About this study
Official title: 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
- Conditions
- Type 2 Diabetes
- Keywords
- Type 2 Diabetes
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
To assess levels of compensation of T2D by HbA1c levels in patients on OAD monotherapy
Measured: 1 visit within 4 month
To assess frequency of target levels of HbA1c ≤ 7% in patients with T2D during OAD monotherapy
Measured: 1 visit within 4 month
Secondary outcomes (4)
To assess fasting glycemia in patients with T2D on OAD monotherapy
Measured: 1 visit within 4 month
To assess postprandial levels of glycemia in patients with T2D during OAD monotherapy
Measured: 1 visit within 4 month
To evaluate the physicians' satisfaction with the results of OAD monotherapy in patients with Typ 2 Diabetes (T2D)
Measured: 1 visit within 4 month
To compare the results of OAD monotherapy in different groups of patients
Measured: 1 visit within 4 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2011 (estimated)
- Study startDec 2010
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 1,849 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Sponsor
- Investigators
- Alexey Stepanov, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01275794
- Sponsor's protocol ID
- NIS-CRU-ONG-2010/1
- Status last verified
- Jun 2012
- First submitted
- 11 Jan 2011
- Last updated
- 4 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening Epidemiological Program on Compensation Evaluation of DM Type 2 Patients on OAD Monotherapy and Physicians Satisfaction of Their Usage
- ClinicalTrials.gov ID
- NCT01275794
- Acronym / sponsor ID
- NIS-CRU-ONG-2010/1
- Conditions
- Type 2 Diabetes
- Keywords
- Type 2 Diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,849 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Bristol-Myers Squibb
- Study start
- Dec 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 12 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is assessment of glycemic control and physicians satisfaction with results of DM2 OAD monotherapy
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Clinical practice
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To assess levels of compensation of T2D by HbA1c levels in patients on OAD monotherapy
Time frame: 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
4 secondary outcomes
To assess fasting glycemia in patients with T2D on OAD monotherapy
Time frame: 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
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
To compare the results of OAD monotherapy in different groups of patients
Time frame: 1 visit within 4 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexey Stepanov study director
AstraZeneca
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes, run by AstraZeneca at 23 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess levels of compensation of T2D by HbA1c levels in patients on OAD monotherapy (time frame: 1 visit within 4 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2012.