METFORMIN HYDROCHLORIDE for Type 2 diabetes mellitus

Inclusion criteria

• {"criterion_text":"- Age 40-70 years old, included.\n- Body Mass Index (BMI) 25-40 kg/m².\n- Diagnosis of T2D according to the American Diabetes Association (ADA) criteria.\n- Patients with T2D insufficiently controlled (HbA1c 7-9.5%) with current (≥6 months) “standard of care” treatment without use of insulin. Subject has provided written informed consent prior to any study specific procedure.\n- Subject has provided written informed consent prior to any study specific procedure.\n- Able and willing to comply with requested study visits and procedures.\n- Contraceptive measures, only for female participants: •\tA female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies: -\tIs a woman of nonchildbearing potential (WONCBP) OR -\tIs a WOCBP and agrees to use a contraceptive method that is highly effective, [with a failure rate of 1-5%], during the study intervention period (to be effective before starting the intervention). Acceptable methods are the following: ○ Male (or female) condom ○ Contraceptive implant ○ IUD (intrauterine device) ○ Surgical sterilization (tubal ligation or partner's vasectomy) ○ Birth control pill ○ Contraceptive patch ○ Vaginal ring ○ Contraceptive injections A WOCBP must have a negative urine pregnancy test before the first administration of study intervention."}

Exclusion criteria

• {"criterion_text":"- Treatment with insulin at the time of screening.\n- HbA1c >9.5% at screening.\n- Treatment with more than 3 glucose lowering drugs at the time of screening.\n- Chronic renal disease defined as eGFR <30mL/min/1.73m² (many glucose-lowering drugs are not approved or require dosage adjustments for being used in these patients) at the screening visit.\n- Hepatic insufficiency which contraindicates the use of glucose-lowering drugs.\n- Currently receiving treatment in another investigational drug study, or less than 30 days since ending treatment on another investigational drug study.\n- Pregnancy or lactation.\n- Women of child bearing potential with no effective contraceptive methods.\n- New York Heart Association (NYHA) Class III or IV congestive heart failure.\n- Subject likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures to the best of the subject and investigator's knowledge.\n- Subject is staff personal directly involved with the study or is a family member of the investigational study staff.\n- Life expectancy predicted to be <2 years."}

Primary endpoints

• {"endpoint_text":"- Proportion of patients achieving goal HbA1c ≤7% at Week 24 in experimental arm versus control arm.","definition_or_measurement_approach":"Proportion of patients with measured HbA1c ≤7% at Week 24; comparison between experimental (pharmacogenetic-guided) arm and control (standard) arm."}

Secondary endpoints

• {"endpoint_text":"- Comparison between patients who have achieved the goal of HbA1c ≤7% at baseline (excluded for randomization) with patients who did not (included for the randomization).","definition_or_measurement_approach":"Comparison of patient groups based on baseline HbA1c ≤7% status; those at goal at baseline are excluded from randomization and compared descriptively with randomized subjects."}
• {"endpoint_text":"- Percentage of patients achieving the goal of dyslipidemia at Week 24: -\tLDL-C of <70 mg/dL without documented CVD at baseline. -\tLDL-C of <55 mg/dL with documented CVD at baseline.","definition_or_measurement_approach":"Proportion of patients meeting LDL-C thresholds at Week 24; thresholds differ according to presence/absence of documented cardiovascular disease at baseline."}
• {"endpoint_text":"- Percentage of patients achieving the goal of blood pressure (<140/90 mmHg) at Week 24.","definition_or_measurement_approach":"Proportion of patients with measured blood pressure <140/90 mmHg at Week 24."}
• {"endpoint_text":"- Number of glucose-lowering drugs’ adverse events reported for each genetic variation identified.","definition_or_measurement_approach":"Count of adverse events related to glucose-lowering drugs stratified by identified genetic variants."}
• {"endpoint_text":"- Proportion of patients in each group presenting each clinical outcome over the study period: •\tAdverse events (AEs) related to glucose-lowering drugs • Serious Adverse events (SAEs) • Changes in clinical laboratory parameters, including renal and hepatic function. • Changes in vital signs","definition_or_measurement_approach":"Proportion of patients experiencing listed safety outcomes during the study period, collected via AE/SAE reporting, laboratory tests (renal/hepatic panels) and vital-sign measurements."}

Spain

Earliest CTIS Part Ii Submission Date

14-03-2025

Latest Decision Or Authorization Date

05-09-2025

Processing Time Days

175

Number Of Sites

3

Number Of Participants

504

Primary sponsor

Full Name

Instituto De Investigacion Sanitaria Fundacion Para La Investigacion Del Hospital Clinico De Valencia-INCLIVA

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Spain

Third parties

• {"country":"Spain","full_name":"Ayuda Investigación Clínica Independiente del Instituto Carlos III (Expediente ICI21/00020).","duties_or_roles":"Monetary support / funding","organisation_type":""}