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SGLT2 inhibitor or metformin as standard treatment in early type 2 diabetes (SMARTEST)
EU CTIS ID: 2024-516228-33-00
What this study is testing
To determine whether SGLT2-inhibitor treatment, as compared to metformin, is beneficial in patients with early T2D in promoting progression-free survival
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Diagnosis of T2D (according to WHO criteria) with less than 4 years duration.
- Men and women, age > 18 years
- BMI 18.5 - 45 kg/m2
- Medication for type 2 diabetes: a) drug naïve, or newly started or short temporary medication (Stratum A: no GLD treatment, except for any ongoing or previous treatment for maximally 4 weeks in total) b) ongoing or previous monotherapy with oral GLD medication for more than 4 weeks in total (Stratum B).
- Participation in the Swedish National Diabetes Register (NDR) and accepting individual data collection from this register and those of SoS/SCB.
- Signed informed consent
You likely can't join if
- Known or suspected other form of diabetes than type 2
- 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
- Ongoing or >4 weeks in total of any previous treatment for type 2 diabetes with: insulin, GLP-1 receptor agonists, SGLT2 inhibitors or combination of any diabetes medications
- Medical need for any specific GLD treatment, eg. insulin due to marked hyperglycemia
See the full eligibility criteria
- Diagnosis of T2D (according to WHO criteria) with less than 4 years duration.
- Men and women, age > 18 years
- BMI 18.5 - 45 kg/m2
- Medication for type 2 diabetes: a) drug naïve, or newly started or short temporary medication (Stratum A: no GLD treatment, except for any ongoing or previous treatment for maximally 4 weeks in total) b) ongoing or previous monotherapy with oral GLD medication for more than 4 weeks in total (Stratum B).
- Participation in the Swedish National Diabetes Register (NDR) and accepting individual data collection from this register and those of SoS/SCB.
- Signed informed consent
- Known or suspected other form of diabetes than type 2
- 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
- Ongoing or >4 weeks in total of any previous treatment for type 2 diabetes with: insulin, GLP-1 receptor agonists, SGLT2 inhibitors or combination of any diabetes medications
- Medical need for any specific GLD treatment, eg. insulin due to marked hyperglycemia
- HbA1c >70 mmol/mol for patients on monotherapy. >80 in drug naïve, but a higher HbA1c can be accepted if the current glucose levels imply a rapid trajectory towards acceptable glucose control
- Contraindication to either metformin or dapagliflozin, or any unacceptable risk with either treatment as assessed by the investigator
- History of established cardiovascular disease: diagnosis of myocardial infarction, angina pectoris, stroke, lower extremity arterial disease, heart failure or ongoing diabetic foot ulcers.
- 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. For example, serious psychiatric or alcohol or substance abuse disorders.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.