Diabetes Type 2MINERVANCT01728714
Better Diabetes Control, Quality - Educate to Achieve Compliance.
An observational study of Diabetes Type 2, run by AstraZeneca at 5 sites in Portugal.
Trial summary
Prospective study to evaluate the impact of an educational programme about diabetes, comparing to normal clinical practice, on treatment compliance and disease control of people with type 2 diabetes followed in the primary care units in Portugal Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Type 2
- Type of treatment
- Pill or oral medicine
- How many people
- 227 participants
- Where
- 5 sitesPortugal
- Study dates
- 19 May 2014to 5 Dec 2018
- 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: primary care setting patients
Who may be able to join
- Individuals with type 2 diabetes
- HbA1c <= 8,5%
- Treated with oral antidiabetics for at least 6 months
Who cannot join
- Treatment with insulin
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Portugal5 sites
Research Site
Almada
Research Site
Espinho
Research Site
Loures
Research Site
Oeiras
Research Site
Santo Antonio Dos Cavaleiros
About this study
Official title: Prospective Study to Evaluate Impact of an Educational Programme About Diabetes, Comparing to Normal Clinical Practice, on Treatment Compliance and Disease Control of People With Type 2 Diabetes Followed in Primary Care Units in Portugal
Prospective study to evaluate the impact of an educational programme about diabetes, comparing to normal clinical practice, on treatment compliance and disease control of people with type 2 diabetes followed in the primary care units in Portugal
Read the detailed description
Prospective study to evaluate the impact of an educational programme about diabetes focusing on treatment compliance, exercise and nutrition, comparing to normal clinical practice, on treatment compliance and disease control of people with type 2 diabetes followed in the primary care units in Portugal.
- Conditions
- Diabetes Type 2
- Keywords
- Diabetes; compliance
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Patient Compliance
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 |
|---|---|---|
| Adults over 18 years old | Adults over 18 years old, with type 2 diabetes, HbA1c <= 8,5%, treated with oral antidiabetics at least for 6 months submitted to an educational programme during 1 year | |
| Adults with HbA1c <= 8,5% | Adults over 18 years old, with type 2 diabetes, HbA1c <= 8,5%, treated with oral antidiabetics at least for 6 months followed according to normal clinical practice during 1 year |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of people with type 2 diabetes treated with oral antidiabetics assessed as compliant with treatment after 1 year educational programme on diabetes, compared with normal clinical practice.
Measured: 1 year
Secondary outcomes (5)
Number of people with type 2 diabetes treated with oral antidiabetics assessed as compliant with diet and physical exercise after 1 year educational programme on diabetes, compared with normal clinical practice.
Measured: 1 year
Number of people with type 2 diabetes treated with oral antidiabetics assessed as compliant with treatment with oral antidiabetics;after 1 year educational programme on diabetes, compared with normal clinical practice.
Measured: 1 year
Measure impact on quality of life, perceived by the patient, following 1 year educational programme on diabetes, compared with normal clinical practice.
Measured: 1 year
Measure the impact of compliance with treatment on glucose control following 1 year educational programme on diabetes, compared with normal clinical practice.
Measured: 1 year
Measure level of satisfaction of the patient with treatment and medical care following 1 year educational programme on diabetes, compared with normal clinical practice.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2012 (estimated)
- Study start19 May 2014
- Primary completion5 Dec 2018
- Study completion5 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Type 2Studies 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-control
- Time perspective
- Prospective
- Enrolment
- 227 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Cláudia Antão, Principal investigator, Research Site 01Pedro Carriço, Principal investigator, Research site 02Carla Gouveia, Principal investigator, Research site 03Jorge Vinagre, Principal investigator, Research site 04
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01728714
- Sponsor's protocol ID
- NIS-CPO-XXX-2012/1
- Other IDs
- CV/No drug/NIS-CPO-XXX-2012/1
- Acronym
- MINERVA
- Status last verified
- Oct 2023
- First submitted
- 14 Nov 2012
- Last updated
- 12 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study to Evaluate Impact of an Educational Programme About Diabetes, Comparing to Normal Clinical Practice, on Treatment Compliance and Disease Control of People With Type 2 Diabetes Followed in Primary Care Units in Portugal
- ClinicalTrials.gov ID
- NCT01728714
- Acronym / sponsor ID
- MINERVA / NIS-CPO-XXX-2012/1
- Conditions
- Diabetes Type 2
- Keywords
- Diabetes; compliance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 227 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 19 May 2014 (actual)
- Primary completion
- 5 Dec 2018 (actual)
- Study completion
- 5 Dec 2018 (actual)
- First posted
- 20 Nov 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.
Prospective study to evaluate the impact of an educational programme about diabetes, comparing to normal clinical practice, on treatment compliance and disease control of people with type 2 diabetes followed in the primary care units in Portugal
Detailed description
Prospective study to evaluate the impact of an educational programme about diabetes focusing on treatment compliance, exercise and nutrition, comparing to normal clinical practice, on treatment compliance and disease control of people with type 2 diabetes followed in the primary care units in Portugal.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adults over 18 years old | – | –Adults over 18 years old, with type 2 diabetes, HbA1c <= 8,5%, treated with oral antidiabetics at least for 6 months submitted to an educational programme during 1 year |
| Adults with HbA1c <= 8,5% | – | –Adults over 18 years old, with type 2 diabetes, HbA1c <= 8,5%, treated with oral antidiabetics at least for 6 months followed according to normal clinical practice during 1 year |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- primary care setting patients
Key inclusion criteria (3 listed)
- Individuals with type 2 diabetes
- HbA1c <= 8,5%
- Treated with oral antidiabetics for at least 6 months
Key exclusion criteria (1 listed)
- Treatment with insulin
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
Number of people with type 2 diabetes treated with oral antidiabetics assessed as compliant with treatment after 1 year educational programme on diabetes, compared with normal clinical practice.
Time frame: 1 year
5 secondary outcomes
Number of people with type 2 diabetes treated with oral antidiabetics assessed as compliant with diet and physical exercise after 1 year educational programme on diabetes, compared with normal clinical practice.
Time frame: 1 year
Number of people with type 2 diabetes treated with oral antidiabetics assessed as compliant with treatment with oral antidiabetics;after 1 year educational programme on diabetes, compared with normal clinical practice.
Time frame: 1 year
Measure impact on quality of life, perceived by the patient, following 1 year educational programme on diabetes, compared with normal clinical practice.
Time frame: 1 year
Measure the impact of compliance with treatment on glucose control following 1 year educational programme on diabetes, compared with normal clinical practice.
Time frame: 1 year
Measure level of satisfaction of the patient with treatment and medical care following 1 year educational programme on diabetes, compared with normal clinical practice.
Time frame: 1 year
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 12 Oct 2023.
- AbstractLink provided by the sponsor.
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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.
Cláudia Antão principal investigator
Research Site 01
Pedro Carriço principal investigator
Research site 02
Carla Gouveia principal investigator
Research site 03
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Type 2, run by AstraZeneca at 5 sites in Portugal.
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 1 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 12 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Portugal. 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?
Number of people with type 2 diabetes treated with oral antidiabetics assessed as compliant with treatment after 1 year educational programme on diabetes, compared with normal clinical practice. (time frame: 1 year). 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 12 Oct 2023.