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A study to evaluate the efficacy and safety of gliclazide MR in patients with type 2 diabetes inadequately controlled with dapagliflozin with or without metformin
EU CTIS ID: 2024-511408-18-00
What this study is testing
To demonstrate the superiority of the free combination of gliclazide MR and dapagliflozin (with or without metformin), in reducing HbA1c after 24 weeks of treatment, compared to placebo and dapagliflozin (with or without metformin) in participants with T2D not optimally controlled with dapagliflozin (with or without metformin).
- Therapeutic confirmatory (Phase III)
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
- Screening period: Participants with T2D diagnosed > 6 months, aged ≥ 18 years, body mass index (BMI) [25 – 40] kg/m2
- Screening period: On stable regimen of diet and exercise and currently treated with: - Either metformin monotherapy at stable daily dose ≥ 1500 mg for at least 12 weeks prior to SCR1 visit and inadequately controlled with HbA1c [8.0%–11.5%] [64-102 mmol/mol] - Or dapagliflozin 10 mg or empagliflozin 10 or 25 mg, in monotherapy or in combination with metformin at daily dose ≥ 1500 mg, daily dose of both treatments must be stable for at least 12 weeks prior to SCR1 visit and inadequately controlled with HbA1c [7.5%-10.5%] [58- 91 mmol/mol]d
- For enrolment in the randomised treatment period: HbA1c [7.0% – 10.5%], (53–91 mmol/mol; centralised value collected within the week prior to W000 visit)
- For enrolment in the randomised treatment period: FPG ≤15 mmol/L (≤ 270 mg/dL), (centralised value collected within the week prior to W000 visit)
- For enrolment in the randomised treatment period: For participant previously treated with metformin monotherapy: participant will be withdrawn if the fasting capillary BG > 15 mmol/L (270 mg/dL; average of 3 fasting SMBG) within the week before SCR3.
You likely can't join if
- With aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3 times the upper limit of normal (ULN), bilirubin > 2 times the ULN, estimated glomerular filtration rate (eGFR) < 45 mL/min/1.73 m2, haemoglobin < 12 g/dL (males) or < 11g/dL (females).
- With contraindication, known or suspected intolerance to gliclazide or dapagliflozin.
- With uncontrolled hypertension (systolic blood pressure [SBP] > 180 mmHg and diastolic [DBP] > 100 mmHg).
- With recent (in the previous 6 months) major cardiovascular events (myocardial infarction, cardiac surgery/ revascularisation, unstable angina, cerebrovascular accident including transient ischaemic attack (TIA), or stroke).
- Treated within 8 weeks prior to the SCR1 visit with sulphonylureas, DPP-4 inhibitors, SGLT2i except dapagliflozin or empagliflozin, GLP-1 receptor agonists, α-glucosidase inhibitors, thiazolidinediones, meglitinides or insulin.
- Treated within 8 weeks prior to the SCR1 visit with bile acid sequestrants (e.g. colesevelam), dopamine receptor agonists (e.g. bromocriptine), and amylin analogues (e.g. pramlintide).
See the full eligibility criteria
- Screening period: Participants with T2D diagnosed > 6 months, aged ≥ 18 years, body mass index (BMI) [25 – 40] kg/m2
- Screening period: On stable regimen of diet and exercise and currently treated with: - Either metformin monotherapy at stable daily dose ≥ 1500 mg for at least 12 weeks prior to SCR1 visit and inadequately controlled with HbA1c [8.0%–11.5%] [64-102 mmol/mol] - Or dapagliflozin 10 mg or empagliflozin 10 or 25 mg, in monotherapy or in combination with metformin at daily dose ≥ 1500 mg, daily dose of both treatments must be stable for at least 12 weeks prior to SCR1 visit and inadequately controlled with HbA1c [7.5%-10.5%] [58- 91 mmol/mol]d
- For enrolment in the randomised treatment period: HbA1c [7.0% – 10.5%], (53–91 mmol/mol; centralised value collected within the week prior to W000 visit)
- For enrolment in the randomised treatment period: FPG ≤15 mmol/L (≤ 270 mg/dL), (centralised value collected within the week prior to W000 visit)
- For enrolment in the randomised treatment period: For participant previously treated with metformin monotherapy: participant will be withdrawn if the fasting capillary BG > 15 mmol/L (270 mg/dL; average of 3 fasting SMBG) within the week before SCR3.
- With aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3 times the upper limit of normal (ULN), bilirubin > 2 times the ULN, estimated glomerular filtration rate (eGFR) < 45 mL/min/1.73 m2, haemoglobin < 12 g/dL (males) or < 11g/dL (females).
- With contraindication, known or suspected intolerance to gliclazide or dapagliflozin.
- With uncontrolled hypertension (systolic blood pressure [SBP] > 180 mmHg and diastolic [DBP] > 100 mmHg).
- With recent (in the previous 6 months) major cardiovascular events (myocardial infarction, cardiac surgery/ revascularisation, unstable angina, cerebrovascular accident including transient ischaemic attack (TIA), or stroke).
- Treated within 8 weeks prior to the SCR1 visit with sulphonylureas, DPP-4 inhibitors, SGLT2i except dapagliflozin or empagliflozin, GLP-1 receptor agonists, α-glucosidase inhibitors, thiazolidinediones, meglitinides or insulin.
- Treated within 8 weeks prior to the SCR1 visit with bile acid sequestrants (e.g. colesevelam), dopamine receptor agonists (e.g. bromocriptine), and amylin analogues (e.g. pramlintide).
- Chronic (> 10 consecutive days) treatment with systemic corticosteroids within 8 weeks prior to the SCR1 visit (intra-basal, intra-articular, intra-ocular, inhaled or topical steroids are permitted).
The study team makes the final eligibility decision.
Where it's taking place
- Georgia
- Armenia
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.
Where is this trial taking place?
Study sites include Georgia; Armenia. Enter your location above to see the nearest site and check your eligibility.
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.