Type 2 DiabetesPhase 4SMARTESTNCT03982381
SGLT2 Inhibitor or Metformin as Standard Treatment of Early Stage Type 2 Diabetes
A Phase 4 study testing Metformin and Dapagliflozin 10 MG in people with Type 2 Diabetes, run by Uppsala University at 1 site in Sweden.
Trial summary
A real-world, nationwide, register-based, randomised trial (RRCT) comparing SGLT2 inhibitors with metformin as standard treatment in early typ 2 diabetes. An open-label trial addressing efficacy with respect to clinically important macro- and microvascular events. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Metformin and Dapagliflozin 10 MG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,067 participants
- Where
- 1 siteSweden
- Study dates
- 5 Sep 2019to 31 Jan 2026
- Phase
- Phase 4
- 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
Who may be able to join
- Men and women ≥18 years old
- T2D (according to World Health Organization (WHO) criteria) of less than 4 years duration
- BMI 18.5-45 kg/m2
- Drug naïve or oral monotherapy with glucose-lowering drug.
- Accepting NDR participation and other register data collection.
Who cannot join
- Known or suspected other form of diabetes than type 2
- Ongoing or more than >4 weeks in total of any previous treatment with: insulin, GLP-1 receptor agonists, SGLT2 inhibitors or combination of any diabetes medications
- Medical need to start or intensify any specific GLD treatment, e.g. insulin due to marked hyperglycemia
- HbA1c >70 mmol/mol for patients on monotherapy, >80 in drug naïve
- Contraindication to either metformin or dapagliflozin, or any unacceptable risk with either treatment as assessed by the investigator
- History or signs of established cardiovascular disease: diagnosis of myocardial infarction, angina pectoris, heart failure, stroke, lower extremity arterial disease, any limb amputation (except due to trauma or malignancy)
Show all 12Show fewer
- Any serious illness or other condition with short life expectancy (<4 yr)
- Renal impairment (eGFR <60 ml/min/1,73m2)
- Any condition, as judged by the investigator, that suggests that the patient will be non-compliant or otherwise unsuitable to study medication or study participation
- Pregnancy or breastfeeding, women of childbearing potential (WOCBP; including perimenopausal women who have had a menstrual period within 1 year) without adequate anticonception during any part of the study period
- Involvement in the planning and/or conduct of the study
- Ongoing participation in another clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Register-based, Randomized, Controlled Trial Comparing Dapagliflozin With Metformin Treatment in Early Stage Type 2 Diabetes Patients by Assessing Mortality and Macro- and Microvascular Complications
A real-world, nationwide, register-based, randomised trial (RRCT) comparing SGLT2 inhibitors with metformin as standard treatment in early typ 2 diabetes. An open-label trial addressing efficacy with respect to clinically important macro- and microvascular events.
Read the detailed description
2067 type 2 diabetes (T2D) patients on monotherapy or drug naive. Randomization 1:1, metformin, dosing according to treatment guidelines or SGLT2 inhibitor, dapagliflozin 10 mg od.
844 events estimated for study completion (90% power to detect hazard ratio (HR) <0.8 for dapagliflozin vs metformin ) Endpoint collection during study duration (about 4 years) from national health care registers: Patient, Prescribed drugs, Cause of death and Population registers; National diabetes register (NDR) Primary analysis according to insulin tolerance test (ITT)
- Conditions
- Type 2 Diabetes
- Being tested
- Metformin, Dapagliflozin 10 MG
- 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.
MetforminDrug
Active comparator
Dapagliflozin 10 MGDrug
Experimental treatment
| Study group | Role | What they receive |
|---|---|---|
| Metformin | Active comparator | Metformin 1000-3000 mg per day according to clinical guidelines. Split into 2-3 doses per day. Receives: Drug: Metformin |
| Dapagliflozin | Experimental | Dapagliflozin 10 mg once daily Receives: Drug: Dapagliflozin 10 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first occurence of a confirmed composite endpoint of death, myocardial infarction, stroke, heart failure, diabetic nephropathy, retinopathy or foot ulcer.
A confirmed composite endpoint includes death, myocardial infarction, stroke, heart failure, diabetic nephropathy, retinopathy or foot ulcer (ICD10 diagnosis codes)
Measured: Time to first event during study period (for each patient 24-48 months, mean 36 months )
Secondary outcomes (20)
Ordinal analysis of components of primary endpoint (see above)
Death, major adverse cardiovascular event or microvascular event at 2 years follow-up (ICD10 diagnosis codes), scored according to severity as specified in statistical analysis plan.
Measured: Events of any of above having occurred during 48 months following randomization.
Time to first occurence of a confirmed composite endpoint of death, myocardial infarction, stroke, heart failure, diabetic nephropathy, retinopathy or foot ulcer (ICD10 diagnosis codes) or initiation of insulin treatment.
A confirmed composite endpoint includes death, myocardial infarction, stroke, heart failure, diabetic nephropathy, retinopathy or foot ulcer (ICD10 diagnosis codes) or initiation of insulin treatment (filled prescription according to Swedish Prescribed Drug Register)
Measured: Time to first event during study period (for each patient 24-48 months, mean 36 months )
Time to first occurence of a confirmed composite endpoint of non-fatal myocardial infarction, stroke, heart failure, unstable angina or cardiovascular death.
A confirmed composite endpoint includes non-fatal myocardial infarction, stroke, heart failure, unstable angina or cardiovascular death (ICD10 diagnosis codes).
Measured: Time to first event during study period (for each patient 24-48 months, mean 36 months )
Time to first occurence of a confirmed composite endpoint of heart failure or cardiovascular death.
A confirmed composite endpoint includes heart failure or cardiovascular death (ICD10 diagnosis codes)
Measured: Time to first event during study period (for each patient 24-48 months, mean 36 months )
Death
Time to death (Population Register data)
Measured: Time to event during study period (for each patient 24-48 months, mean 36 months)
Microvascular events, first of; occurrence or progression of retinopathy, nephropathy, diabetic foot lesions
Time to first event of: occurrence or progression of retinopathy, nephropathy, diabetic foot ulcers (ICD10 diagnosis codes)
Measured: Time to first event during study period (for each patient 24-48 months, mean 36 months )
Need for insulin treatment
Time to initiation of insulin treatment (filled prescription according to Swedish Prescribed Drug Register)
Measured: Time to first event during study period (for each patient 24-48 months, mean 36 months )
Treatment failure, defined as add-on or switch to another glucose-lowering drug
Time to event of: add-on or switch to another glucose-lowering drug (filled prescription according to Swedish Prescribed Drug Register)
Measured: Time to first event during study period (for each patient 24-48 months, mean 36 months )
Change in glycemic control
HbA1c level (mmol/mol)
Measured: Change during study period, at 12, 24, 36 and 48 months
Change in LDL-cholesterol
Change in LDL cholesterol from baseline (mmol/L)
Measured: Change during study period; assessment at baseline, 12, 24, 36 and 48 months
Change in HDL-cholesterol
Change in HDL cholesterol from baseline (mmol/L)
Measured: Change during study period; assessment at baseline, 12, 24, 36 and 48 months
Change in total cholesterol
Change in total cholesterol from baseline (mmol/L)
Measured: Change during study period; assessment at baseline, 12, 24, 36 and 48 months
Change in triglycerides
Change in triglycerides from baseline (mmol/L)
Measured: Change during study period; assessment at baseline, 12, 24, 36 and 48 months
Change in albuminuria
Change in urinary albumin/creatinine ratio (mg/mol)
Measured: Change during study period; assessment at baseline, 12, 24, 36 and 48 months
Change in blood pressure
Change in systolic and diastolic blood pressure (mm Hg)
Measured: Change during study period; assessment at baseline, 12, 24, 36 and 48 months
Change in body weight
Change in body weight (kg)
Measured: Change during study period; assessment at baseline, 12, 24, 36 and 48 months
Change in BMI
Change in BMI (kg/m2)
Measured: Change during study period; assessment at baseline, 12, 24, 36 and 48 months
Health care costs
Diagnosis-based (IDG) costs for all health care during study period plus medication cost
Measured: Accumulated health care costs during study period (for each patient 24-48 months, mean 36 months )
Health-related quality of life
The Short Form 36-Item Survey version 1.0 (SF-36) is used for patient-reported health and consists of 36 questions. The weighted sums of scores in each of eight defined domains (relating to experience of different aspects of general health, symptoms and functions) are compiled into different scales according to a standardized algorithm. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability, i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. We use the public domain version, called the the RAND-36 Item Health Survey.
Measured: Assessment at baseline, 12, 24 months
Health-related quality of life with respect to diabetes treatment satisfaction.
The Diabetes Treatment Satisfaction Questionnaire (DTSQ) is used. It has been developed to assess patient satisfaction with diabetes treatment. The questionnaire is composed of two different factors. The first factor assesses treatment satisfaction and consists of six questions and the second factor consists of two questions, which assess the burden from hyper- and hypoglycemia. Treatment satisfaction is assessed as the sum of the scores of the six questions on the first factor (total score 36), with a higher score indicating higher treatment satisfaction.
Measured: Assessment at baseline, 12, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2019
- Study start5 Sep 2019
- Primary completion31 Jan 2026
- Study completion31 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective randomized, open label, blinded endpoint design (PROBE). Multicenter study.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 2,067 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Collaborators
- Uppsala University Hospital, Swedish Healthcare Regions, National Board of Health and Welfare, Sweden, The Swedish National Diabetes Register
- Responsible party
- Sponsor
- Investigators
- Jan Eriksson, MD, Principal investigator, Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03982381
- Sponsor's protocol ID
- SMART-2019
- Other IDs
- 2019-001046-17, 2019
- Acronym
- SMARTEST
- Status last verified
- Mar 2026
- First submitted
- 27 May 2019
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will be available to all scientific collaborators
Publications
Eriksson JW, Fanni G, Lundqvist MH, Jansson S, Radholm K, Sofizadeh S, Patsoukaki V, Nilsson A, Lindholm D, Rolandsson O, Norhammar A, Granstam E, Eliasson B, Bennet L, Sundstrom J. SGLT2 inhibitor or metformin as standard treatment in early-stage type 2 diabetes? Baseline data in SMARTEST, a novel, decentralised, register-based randomised trial on prevention of diabetic complications. Diabetes Obes Metab. 2026 Feb;28(2):1327-1338. doi: 10.1111/dom.70320. Epub 2025 Nov 28.
PubMed 41311237El-Damanawi R, Stanley IK, Staatz C, Pascoe EM, Craig JC, Johnson DW, Mallett AJ, Hawley CM, Milanzi E, Hiemstra TF, Viecelli AK. Metformin for preventing the progression of chronic kidney disease. Cochrane Database Syst Rev. 2024 Jun 4;6(6):CD013414. doi: 10.1002/14651858.CD013414.pub2.
PubMed 38837240Sundstrom J, Kristofi R, Ostlund O, Bennet L, Eliasson B, Jansson S, Leksell J, Almby K, Lundqvist M, Eriksson JW; SMARTEST study group (see list in Appendix). A registry-based randomised trial comparing an SGLT2 inhibitor and metformin as standard treatment of early stage type 2 diabetes (SMARTEST): Rationale, design and protocol. J Diabetes Complications. 2021 Oct;35(10):107996. doi: 10.1016/j.jdiacomp.2021.107996. Epub 2021 Jul 21.
PubMed 34389234Gnesin F, Thuesen ACB, Kahler LKA, Madsbad S, Hemmingsen B. Metformin monotherapy for adults with type 2 diabetes mellitus. Cochrane Database Syst Rev. 2020 Jun 5;6(6):CD012906. doi: 10.1002/14651858.CD012906.pub2.
PubMed 32501595
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Register-based, Randomized, Controlled Trial Comparing Dapagliflozin With Metformin Treatment in Early Stage Type 2 Diabetes Patients by Assessing Mortality and Macro- and Microvascular Complications
- ClinicalTrials.gov ID
- NCT03982381
- Acronym / sponsor ID
- SMARTEST / SMART-2019
- Conditions
- Type 2 Diabetes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,067 participants (actual)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Collaborators
- Uppsala University Hospital, Swedish Healthcare Regions, National Board of Health and Welfare, Sweden, The Swedish National Diabetes Register
- Study start
- 5 Sep 2019 (actual)
- Primary completion
- 31 Jan 2026 (actual)
- Study completion
- 31 Jan 2026 (actual)
- First posted
- 11 Jun 2019 (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.
A real-world, nationwide, register-based, randomised trial (RRCT) comparing SGLT2 inhibitors with metformin as standard treatment in early typ 2 diabetes. An open-label trial addressing efficacy with respect to clinically important macro- and microvascular events.
Detailed description
2067 type 2 diabetes (T2D) patients on monotherapy or drug naive. Randomization 1:1, metformin, dosing according to treatment guidelines or SGLT2 inhibitor, dapagliflozin 10 mg od.
844 events estimated for study completion (90% power to detect hazard ratio (HR) <0.8 for dapagliflozin vs metformin ) Endpoint collection during study duration (about 4 years) from national health care registers: Patient, Prescribed drugs, Cause of death and Population registers; National diabetes register (NDR) Primary analysis according to insulin tolerance test (ITT)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective randomized, open label, blinded endpoint design (PROBE). Multicenter study.
| Arm | Type | Receives |
|---|---|---|
| Metformin | Active comparator | Drug: MetforminMetformin 1000-3000 mg per day according to clinical guidelines. Split into 2-3 doses per day. |
| Dapagliflozin | Experimental | Drug: Dapagliflozin 10 MGDapagliflozin 10 mg once daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men and women ≥18 years old
- T2D (according to World Health Organization (WHO) criteria) of less than 4 years duration
- BMI 18.5-45 kg/m2
- Drug naïve or oral monotherapy with glucose-lowering drug.
- Accepting NDR participation and other register data collection.
Key exclusion criteria (12 listed)
- Known or suspected other form of diabetes than type 2
- Ongoing or more than >4 weeks in total of any previous treatment with: insulin, GLP-1 receptor agonists, SGLT2 inhibitors or combination of any diabetes medications
- Medical need to start or intensify any specific GLD treatment, e.g. insulin due to marked hyperglycemia
- HbA1c >70 mmol/mol for patients on monotherapy, >80 in drug naïve
- Contraindication to either metformin or dapagliflozin, or any unacceptable risk with either treatment as assessed by the investigator
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MetforminActive comparator | Drug | Metformin |
| Dapagliflozin 10 MGExperimental treatment | Drug | Dapagliflozin |
Primary outcome
Time to first occurence of a confirmed composite endpoint of death, myocardial infarction, stroke, heart failure, diabetic nephropathy, retinopathy or foot ulcer.
Time frame: Time to first event during study period (for each patient 24-48 months, mean 36 months )
A confirmed composite endpoint includes death, myocardial infarction, stroke, heart failure, diabetic nephropathy, retinopathy or foot ulcer (ICD10 diagnosis codes)
20 secondary outcomes
Ordinal analysis of components of primary endpoint (see above)
Time frame: Events of any of above having occurred during 48 months following randomization.
Time to first occurence of a confirmed composite endpoint of death, myocardial infarction, stroke, heart failure, diabetic nephropathy, retinopathy or foot ulcer (ICD10 diagnosis codes) or initiation of insulin treatment.
Time frame: Time to first event during study period (for each patient 24-48 months, mean 36 months )
Time to first occurence of a confirmed composite endpoint of non-fatal myocardial infarction, stroke, heart failure, unstable angina or cardiovascular death.
Time frame: Time to first event during study period (for each patient 24-48 months, mean 36 months )
Time to first occurence of a confirmed composite endpoint of heart failure or cardiovascular death.
Time frame: Time to first event during study period (for each patient 24-48 months, mean 36 months )
Death
Time frame: Time to event during study period (for each patient 24-48 months, mean 36 months)
Microvascular events, first of; occurrence or progression of retinopathy, nephropathy, diabetic foot lesions
Time frame: Time to first event during study period (for each patient 24-48 months, mean 36 months )
Need for insulin treatment
Time frame: Time to first event during study period (for each patient 24-48 months, mean 36 months )
Treatment failure, defined as add-on or switch to another glucose-lowering drug
Time frame: Time to first event during study period (for each patient 24-48 months, mean 36 months )
Change in glycemic control
Time frame: Change during study period, at 12, 24, 36 and 48 months
Change in LDL-cholesterol
Time frame: Change during study period; assessment at baseline, 12, 24, 36 and 48 months
Change in HDL-cholesterol
Time frame: Change during study period; assessment at baseline, 12, 24, 36 and 48 months
Change in total cholesterol
Time frame: Change during study period; assessment at baseline, 12, 24, 36 and 48 months
Change in triglycerides
Time frame: Change during study period; assessment at baseline, 12, 24, 36 and 48 months
Change in albuminuria
Time frame: Change during study period; assessment at baseline, 12, 24, 36 and 48 months
Change in blood pressure
Time frame: Change during study period; assessment at baseline, 12, 24, 36 and 48 months
Change in body weight
Time frame: Change during study period; assessment at baseline, 12, 24, 36 and 48 months
Change in BMI
Time frame: Change during study period; assessment at baseline, 12, 24, 36 and 48 months
Health care costs
Time frame: Accumulated health care costs during study period (for each patient 24-48 months, mean 36 months )
Health-related quality of life
Time frame: Assessment at baseline, 12, 24 months
Health-related quality of life with respect to diabetes treatment satisfaction.
Time frame: Assessment at baseline, 12, 24 months
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 Mar 2026.
- Derived from this study: PubMed 41311237Eriksson JW, Fanni G, Lundqvist MH, Jansson S, Radholm K, Sofizadeh S, Patsoukaki V, Nilsson A, Lindholm D, Rolandsson O, Norhammar A, Granstam E, Eliasson B, Bennet L, Sundstrom J. SGLT2 inhibitor or metformin as standard treatment in early-stage type 2 diabetes? Baseline data in SMARTEST, a novel, decentralised, register-based randomised trial on prevention of diabetic complications. Diabetes Obes Metab. 2026 Feb;28(2):1327-1338. doi: 10.1111/dom.70320. Epub 2025 Nov 28.
- Derived from this study: PubMed 38837240El-Damanawi R, Stanley IK, Staatz C, Pascoe EM, Craig JC, Johnson DW, Mallett AJ, Hawley CM, Milanzi E, Hiemstra TF, Viecelli AK. Metformin for preventing the progression of chronic kidney disease. Cochrane Database Syst Rev. 2024 Jun 4;6(6):CD013414. doi: 10.1002/14651858.CD013414.pub2.
- Derived from this study: PubMed 34389234Sundstrom J, Kristofi R, Ostlund O, Bennet L, Eliasson B, Jansson S, Leksell J, Almby K, Lundqvist M, Eriksson JW; SMARTEST study group (see list in Appendix). A registry-based randomised trial comparing an SGLT2 inhibitor and metformin as standard treatment of early stage type 2 diabetes (SMARTEST): Rationale, design and protocol. J Diabetes Complications. 2021 Oct;35(10):107996. doi: 10.1016/j.jdiacomp.2021.107996. Epub 2021 Jul 21.
- Derived from this study: PubMed 32501595Gnesin F, Thuesen ACB, Kahler LKA, Madsbad S, Hemmingsen B. Metformin monotherapy for adults with type 2 diabetes mellitus. Cochrane Database Syst Rev. 2020 Jun 5;6(6):CD012906. doi: 10.1002/14651858.CD012906.pub2.
- Individual participant dataSharing planned: No. IPD will be available to all scientific collaborators
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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.
Jan Eriksson, MD principal investigator
Uppsala University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Metformin and Dapagliflozin 10 MG in people with Type 2 Diabetes, run by Uppsala University at 1 site in Sweden.
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 12 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 Mar 2026. 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 Sweden. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Time to first occurence of a confirmed composite endpoint of death, myocardial infarction, stroke, heart failure, diabetic nephropathy, retinopathy or foot ulcer. (time frame: Time to first event during study period (for each patient 24-48 months, mean 36 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 NCT03982381, which also lists 4 linked publications.
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 Mar 2026.