Type 2 DiabetesEDUDIANCT06704802
Observational Cohort Study Evaluating the Effectiveness of an Education Program (NGAYDAUTIEN) in Combination With Gliclazide MR in the Management of Uncontrolled Type 2 Diabetic Patients.
An observational study of Type 2 Diabetes, run by Servier Affaires Médicales at 1 site in France.
Trial summary
The primary objective is to assess the change of HbA1c level from baseline after a 6-month follow up among uncontrolled patients with T2D who will be initiated to Diamicron® MR 60 (originator product) plus an educational program (NGAYDAUTIEN) as monotherapy or in add on to metformin in comparison to an initiation of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes
- How many people
- 678 participants
- Where
- 1 siteFrance
- Study dates
- 4 Nov 2022to 28 Jun 2024
- 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: Male and female who have a diagnosis of uncontrolled T2D and who initiate a new OAD monotherapy or on top of metformin
Who may be able to join
- Aged at least 18 years (without upper limit of age)
- HbA1c value is required at the baseline visit
- Patients with diagnosis of uncontrolled T2D
- Initiation of a new OAD as monotherapy or on top of metformin
- Patient follow-up within the scope of the current medical practice and in the same health center during the 6-month period.
Who cannot join
- Diagnosis of diabetes other than T2D
- HbA1c value not available at baseline
- Patients who previously attended to the NDT educational program for T2D management
- Required at baseline an insulin therapy according to national guideline
- Used any other OAD (except metformin)
- Used a single pill combination in addition to the medicine of interest
- Have a severe disease (i.e. cirrhosis, end stage renal disease…)
- Are unlikely to cooperate in the study or to follow the educational program
Trial locations and contacts
1 site in 1 country.
About this study
The primary objective is to assess the change of HbA1c level from baseline after a 6-month follow up among uncontrolled patients with T2D who will be initiated to Diamicron® MR 60 (originator product) plus an educational program (NGAYDAUTIEN) as monotherapy or in add on to metformin in comparison to an initiation of an Oral Antidiabetic Drug (OAD) (except Diamicron®) as monotherapy or in add on to metformin.
- Conditions
- Type 2 Diabetes
- Keywords
- observational, HbA1c, type 2 diabetes, Diamicron® MR 60, T2D, patient educational program
- 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 |
|---|---|---|
| Diamicron® MR 60 (originator product) plus educational program | uncontrolled patients with T2D who will be initiated to Diamicron® MR 60 (originator product) plus an educational program | |
| other OAD except Diamicron® | uncontrolled patients with T2D who will be initiated other OAD except Diamicron® |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of HbA1c level (measured in %) from baseline after a 6-month follow-up among the 2 arms
Measured: from baseline to 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2024
- Study start4 Nov 2022
- Primary completion28 Jun 2024
- Study completion28 Jun 2024
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.
- 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
- 678 participants (actual)
Sponsor and investigators
- Lead sponsor
- Servier Affaires Médicales
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06704802
- Sponsor's protocol ID
- DIM-05762-006
- Acronym
- EDUDIA
- Status last verified
- Nov 2024
- First submitted
- 22 Nov 2024
- Last updated
- 26 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Cohort Study Evaluating the Effectiveness of an Education Program (NGAYDAUTIEN) in Combination With Gliclazide MR in the Management of Uncontrolled Type 2 Diabetic Patients.
- ClinicalTrials.gov ID
- NCT06704802
- Acronym / sponsor ID
- EDUDIA / DIM-05762-006
- Conditions
- Type 2 Diabetes
- Keywords
- observational, HbA1c, type 2 diabetes, Diamicron® MR 60, T2D, patient educational program
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 678 participants (actual)
- Lead sponsor
- Servier Affaires MédicalesIndustry (pharma, biotech, devices)
- Study start
- 4 Nov 2022 (actual)
- Primary completion
- 28 Jun 2024 (actual)
- Study completion
- 28 Jun 2024 (actual)
- First posted
- 26 Nov 2024 (actual)
- 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 primary objective is to assess the change of HbA1c level from baseline after a 6-month follow up among uncontrolled patients with T2D who will be initiated to Diamicron® MR 60 (originator product) plus an educational program (NGAYDAUTIEN) as monotherapy or in add on to metformin in comparison to an initiation of an Oral Antidiabetic Drug (OAD) (except Diamicron®) as monotherapy or in add on to metformin.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diamicron® MR 60 (originator product) plus educational program | – | –uncontrolled patients with T2D who will be initiated to Diamicron® MR 60 (originator product) plus an educational program |
| other OAD except Diamicron® | – | –uncontrolled patients with T2D who will be initiated other OAD except Diamicron® |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male and female who have a diagnosis of uncontrolled T2D and who initiate a new OAD monotherapy or on top of metformin
Key inclusion criteria (5 listed)
- Aged at least 18 years (without upper limit of age)
- HbA1c value is required at the baseline visit
- Patients with diagnosis of uncontrolled T2D
- Initiation of a new OAD as monotherapy or on top of metformin
- Patient follow-up within the scope of the current medical practice and in the same health center during the 6-month period.
Key exclusion criteria (8 listed)
- Diagnosis of diabetes other than T2D
- HbA1c value not available at baseline
- Patients who previously attended to the NDT educational program for T2D management
- Required at baseline an insulin therapy according to national guideline
- Used any other OAD (except metformin)
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
change of HbA1c level (measured in %) from baseline after a 6-month follow-up among the 2 arms
Time frame: from baseline to 6-month follow-up
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 26 Nov 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site 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 Servier Affaires Médicales at 1 site in France.
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 5 inclusion and 8 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 26 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
change of HbA1c level (measured in %) from baseline after a 6-month follow-up among the 2 arms (time frame: from baseline to 6-month 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 26 Nov 2024.