Type 2 DiabetesADD2DIANCT06708091
Real-world Clinical Effectiveness and Patient Insight Associated With Adding Sodium Glucose Co-transporter 2 Inhibitor to Gliclazide Modified Release
An observational study of Type 2 Diabetes, run by Servier Affaires Médicales at 1 site in France.
Trial summary
The study objectives are to assess over the gliclazide MR-SGLT2i combined treatment course in patients with T2DM adding SGLT2i to gliclazide MR-based therapy. The primary objective is to determine the effectiveness of adding SGLT2i to gliclazide MR-based therapy in patients with T2DM, as measured by HbA1c changes. 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
- 537 participants
- Where
- 1 siteFrance
- Study dates
- 15 Feb 2022to 31 May 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 are treated by Gliclazide MR 60 at index date and who started with SGLT2i added to gliclazide MR with a minimum of 60 days of these combined treatments during the eligibility period
Who may be able to join
- Patient diagnosed with T2DM for at least two years prior to index date
- Patient aged ≥18 years at the index date
- Patient naïve to SGLT2i prior to index date
- Patient treated with gliclazide MR at a minimum daily dose of 60 mg at the index date
- Starting treatment with SGLT2i added to gliclazide MR based therapy, during the eligibility period, with a minimum of 60 days of combined gliclazide MR-SGLT2i treatment
- Presence of at least two assessments of HbA1c laboratory test results from the medical records
Who cannot join
- Diagnosis of diabetes other than T2DM (e.g., type 1, gestational) at index date
- Use of antidiabetic drugs other than those permitted by the inclusion criteria, at index date
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Retrospective Chart Review Combined With a Prospective Cross-sectional Survey and Interviews on Patients With Type 2 Diabetes Mellitus to Assess Effectiveness of Adding SodiumGlucose Co-transporter 2 Inhibitor to Gliclazide Modified Release
The study objectives are to assess over the gliclazide MR-SGLT2i combined treatment course in patients with T2DM adding SGLT2i to gliclazide MR-based therapy.
The primary objective is to determine the effectiveness of adding SGLT2i to gliclazide MR-based therapy in patients with T2DM, as measured by HbA1c changes.
- Conditions
- Type 2 Diabetes
- Keywords
- observational, HbA1c, type 2 diabetes, gliclazide MR, SGLT2i, gliclazide MR combined to SGLT2i, retrospective, chart review
- 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 |
|---|---|---|
| population description | adult patients with T2DM who initiated add-on SGLT2i treatment to gliclazide MR 60 mg, in routine practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
effectiveness of adding SGLT2i to gliclazide MR
To determine the effectiveness of adding SGLT2i to gliclazide MR-based therapy in patients with T2DM, as measured by HbA1c changes (in %)
Measured: from index date (date of SGLT2i adding to gliclazide MR) to discontinuation of the combination (at least 2 months) or date of data collection initiation during the eligibility period, loss to follow-up, or death, whichever occurs first (approx 2 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2024
- Study start15 Feb 2022
- Primary completion31 May 2024
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 537 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
- NCT06708091
- Sponsor's protocol ID
- DIM-05762-005
- Acronym
- ADD2DIA
- Status last verified
- Nov 2024
- First submitted
- 22 Nov 2024
- Last updated
- 27 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Moreira RO, Nicodemus NA Jr, Comlekci A, Yu M, Almalki MH. ADD2Dia: Real-World Clinical Effectiveness of Adding a Sodium-Glucose Cotransporter 2 Inhibitor to Gliclazide-Based Therapy in Type 2 Diabetes. Adv Ther. 2025 Dec;42(12):6295-6309. doi: 10.1007/s12325-025-03394-2. Epub 2025 Nov 1.
PubMed 41175321
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Chart Review Combined With a Prospective Cross-sectional Survey and Interviews on Patients With Type 2 Diabetes Mellitus to Assess Effectiveness of Adding SodiumGlucose Co-transporter 2 Inhibitor to Gliclazide Modified Release
- ClinicalTrials.gov ID
- NCT06708091
- Acronym / sponsor ID
- ADD2DIA / DIM-05762-005
- Conditions
- Type 2 Diabetes
- Keywords
- observational, HbA1c, type 2 diabetes, gliclazide MR, SGLT2i, gliclazide MR combined to SGLT2i, retrospective, chart review
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 537 participants (actual)
- Lead sponsor
- Servier Affaires MédicalesIndustry (pharma, biotech, devices)
- Study start
- 15 Feb 2022 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 27 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 study objectives are to assess over the gliclazide MR-SGLT2i combined treatment course in patients with T2DM adding SGLT2i to gliclazide MR-based therapy.
The primary objective is to determine the effectiveness of adding SGLT2i to gliclazide MR-based therapy in patients with T2DM, as measured by HbA1c changes.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| population description | – | –adult patients with T2DM who initiated add-on SGLT2i treatment to gliclazide MR 60 mg, in routine practice |
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 are treated by Gliclazide MR 60 at index date and who started with SGLT2i added to gliclazide MR with a minimum of 60 days of these combined treatments during the eligibility period
Key inclusion criteria (6 listed)
- Patient diagnosed with T2DM for at least two years prior to index date
- Patient aged ≥18 years at the index date
- Patient naïve to SGLT2i prior to index date
- Patient treated with gliclazide MR at a minimum daily dose of 60 mg at the index date
- Starting treatment with SGLT2i added to gliclazide MR based therapy, during the eligibility period, with a minimum of 60 days of combined gliclazide MR-SGLT2i treatment
Key exclusion criteria (2 listed)
- Diagnosis of diabetes other than T2DM (e.g., type 1, gestational) at index date
- Use of antidiabetic drugs other than those permitted by the inclusion criteria, at index date
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
effectiveness of adding SGLT2i to gliclazide MR
Time frame: from index date (date of SGLT2i adding to gliclazide MR) to discontinuation of the combination (at least 2 months) or date of data collection initiation during the eligibility period, loss to follow-up, or death, whichever occurs first (approx 2 months)
To determine the effectiveness of adding SGLT2i to gliclazide MR-based therapy in patients with T2DM, as measured by HbA1c changes (in %)
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 27 Nov 2024.
- Derived from this study: PubMed 41175321Moreira RO, Nicodemus NA Jr, Comlekci A, Yu M, Almalki MH. ADD2Dia: Real-World Clinical Effectiveness of Adding a Sodium-Glucose Cotransporter 2 Inhibitor to Gliclazide-Based Therapy in Type 2 Diabetes. Adv Ther. 2025 Dec;42(12):6295-6309. doi: 10.1007/s12325-025-03394-2. Epub 2025 Nov 1.
- 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 6 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 27 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?
effectiveness of adding SGLT2i to gliclazide MR (time frame: from index date (date of SGLT2i adding to gliclazide MR) to discontinuation of the combination (at least 2 months) or date of data collection initiation during the eligibility period, loss to follow-up, or death, whichever occurs first (approx 2 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06708091, which also lists 1 linked publication.
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 27 Nov 2024.