Diabetes Mellitus, Non-Insulin-DependentOPTIMISENCT01694758
OPtimal Type 2 dIabetes Management Including Benchmarking and Standard Treatment in CEEMEA
An observational study of Diabetes Mellitus, Non-Insulin-Dependent, run by AstraZeneca at 20 sites in 2 countries.
Trial summary
OPTIMISE-CEEMEA is a multinational, multi-centre, observational, prospective study which will include patients suffering from diabetes type 2, treated or untreated, insulin dependent or not insulin dependent. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Non-Insulin-Dependent
- How many people
- 733 participants
- Where
- 20 sitesin 2 countries
- Study dates
- Nov 2012to Mar 2014
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with diabetes type 2
Who may be able to join
- Subjects suffering from diabetes type 2,
- treated or untreated,
- insulin dependent or not insulin dependent Able to read and send SMS (if SMS applicable)
Who cannot join
- Type 1 diabetes Pregnancy diabetes
- Hospitalization at the moment of enrollment in the study
Trial locations and contacts
20 sites in 2 countries.
20 sites in 2 countries
Romania16 sites
Research Site
Alexandria
Research Site
Brasov
Research Site
Bucharest
Research Site
Cluj-Napoca
Research Site
Constanța
Research Site
Craiova
Research Site
Galati
Research Site
Giurgiu
Research Site
Iași
Research Site
Oradea
Research Site
Piteşti
Research Site
Ploieşti
Research Site
Satu Mare
Research Site
Tg Jiu
Research Site
Tg Mures
Research Site
Timișoara
Bulgaria4 sites
Research Site
Blagoevgrad
Research Site
Pleven
Research Site
Plovdiv
Research Site
Sofia
About this study
Official title: OPtimal Type 2 dIabetes Management Including Benchmarking and Standard Treatment in CEEMEA (OPTIMISE)
OPTIMISE-CEEMEA is a multinational, multi-centre, observational, prospective study which will include patients suffering from diabetes type 2, treated or untreated, insulin dependent or not insulin dependent.
In this study we aim to explore at a primary care level whether the use of benchmarking against a set of guideline-based reference values on a patient basis, may improve quality of patient care, in particular control of diabetes, lipids and blood pressure.
- Conditions
- Diabetes Mellitus, Non-Insulin-Dependent
- Keywords
- Benchmarking could improve quality of patient care, ESC and ATP III Guidelines
- 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 |
|---|---|---|
| Patients with diabetes type 2 | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients in the benchmarking group achieving pre-set targets for HbA1c1
To investigate whether the use of benchmarking could improve quality of patient care, in particular the control of diabetes, lipids and blood pressure, expressed as the percentage of patients in the benchmarking group achieving pre-set targets for HbA1c1
Measured: after 12 months of follow-up
Secondary outcomes (3)
Quality of patient care improvement, in particular the control of diabetes, lipids and blood pressure
To investigate whether the use of benchmarking could improve quality of patient care, in particular the control of diabetes, lipids and blood pressure
Measured: after 12 months of follow-up versus baseline
Markers of preventive screening
To follow up evolution markers of preventive screening; retinopathy, neuropathy, dietary counseling, smoking habits, BMI, waist circumference, physical activity
Measured: after 12 months of follow-up versus baseline
The LDL cholesterol parameter of the primary and secondary objectives according to ATP III guidelines
To investigate the LDL cholesterol parameter of the primary and secondary objectives according to ATP III guidelines
Measured: after 12 months of follow-up versus baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2012 (estimated)
- Study startNov 2012
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Non-Insulin-DependentStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 733 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dan Isacoff, ASSOC. PROF., Principal investigator, University of Medicine and Pharmacy Carol Davila, Bucharest, Romania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01694758
- Sponsor's protocol ID
- NIS-CME-XXX-2012/1
- Acronym
- OPTIMISE
- Status last verified
- Aug 2014
- First submitted
- 25 Sep 2012
- Last updated
- 15 Aug 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OPtimal Type 2 dIabetes Management Including Benchmarking and Standard Treatment in CEEMEA (OPTIMISE)
- ClinicalTrials.gov ID
- NCT01694758
- Acronym / sponsor ID
- OPTIMISE / NIS-CME-XXX-2012/1
- Conditions
- Diabetes Mellitus, Non-Insulin-Dependent
- Keywords
- Benchmarking could improve quality of patient care, ESC and ATP III Guidelines
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 733 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 27 Sep 2012 (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.
OPTIMISE-CEEMEA is a multinational, multi-centre, observational, prospective study which will include patients suffering from diabetes type 2, treated or untreated, insulin dependent or not insulin dependent.
In this study we aim to explore at a primary care level whether the use of benchmarking against a set of guideline-based reference values on a patient basis, may improve quality of patient care, in particular control of diabetes, lipids and blood pressure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with diabetes type 2 | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with diabetes type 2
Key inclusion criteria (3 listed)
- Subjects suffering from diabetes type 2,
- treated or untreated,
- insulin dependent or not insulin dependent Able to read and send SMS (if SMS applicable)
Key exclusion criteria (2 listed)
- Type 1 diabetes Pregnancy diabetes
- Hospitalization at the moment of enrollment in the study
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
Percentage of patients in the benchmarking group achieving pre-set targets for HbA1c1
Time frame: after 12 months of follow-up
To investigate whether the use of benchmarking could improve quality of patient care, in particular the control of diabetes, lipids and blood pressure, expressed as the percentage of patients in the benchmarking group achieving pre-set targets for HbA1c1
3 secondary outcomes
Quality of patient care improvement, in particular the control of diabetes, lipids and blood pressure
Time frame: after 12 months of follow-up versus baseline
Markers of preventive screening
Time frame: after 12 months of follow-up versus baseline
The LDL cholesterol parameter of the primary and secondary objectives according to ATP III guidelines
Time frame: after 12 months of follow-up versus baseline
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 15 Aug 2014.
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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.
Dan Isacoff, ASSOC. PROF. principal investigator
University of Medicine and Pharmacy Carol Davila, Bucharest, Romania
20 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Non-Insulin-Dependent, run by AstraZeneca at 20 sites in 2 countries.
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 3 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 15 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Romania, Bulgaria. 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?
Percentage of patients in the benchmarking group achieving pre-set targets for HbA1c1 (time frame: after 12 months of follow-up). 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 15 Aug 2014.