| Outcome Measures: |
Primary: Comparison of HbA1c ≤7% goal at Week 24 between Pharmacogenetic-Guided and Standard Treatment in Type 2 Diabetes, The primary objective is to compare the proportion of patients achieving HbA1c ≤7% at Week 24 between pharmacogenetic-guided treatment arm and standard treatment arm in subjects with insufficiently controlled type 2 diabetes. The null hypothesis is that the proportion of patients achieving this goal is equal in both the pharmacogenetic-guided and standard treatment groups., From baseline to the end of treatment at 24 weeks | Secondary: Comparison of Pharmacogenetic Markers and Treatment Response Pre-Randomization, Comparison of pharmacogenetic markers with the effect of pre-randomization treatment. This will be measured by analyzing the pharmacogenetic markers before randomization and their relationship to the treatment response. The endpoint will be the comparison between the proportion of patients who achieved HbA1c ≤7% at baseline (excluded from randomization) and those who did not (included for randomization)., Before randomization to the end of treatment at 24 weeks | Other: Exploratory Objective (1): percentage of patients achieving the dyslipidemia goal (LDL colesterol/LDL-C <70 mg/dL or <55 mg/Dl) in patients with or without cardiovascular disease (CVD), Percentage of patients achieving the dyslipidemia goal at Week 24, defined as: * LDL-C \<70 mg/dL in patients without documented CVD at baseline. * LDL-C \<55 mg/dL in patients with documented CVD at baseline. Additionally, the relationship between these outcomes and genetic variations in the subjects will be measured., From baseline to the end of treatment at 24 weeks|Exploratory Objective (3): percentage of patients achieving the goal of <140/90 mmHg systolic and diastolic pressure, To evaluate the percentage of patients achieving the goal of blood pressure as defined in the study (\<140/90 mmHg at Week 24) and its relationship with genetic variations present in those subjects., From baseline to the end of treatment at 24 weeks|Exploratory Objective (4): glucose-lowering drugs' adverse events, To evaluate incidence and relatedness of glucose-lowering drugs' adverse events with genetic variations., From baseline to the end of treatment at 24 weeks|Safety Objective (1): Incidence of Treatment-Emergent Adverse Events (AEs), To evaluate the percentage of patients who experienced treatment-emergent adverse events (AEs) from baseline to Week 24 in each treatment group. This will be measured by comparing the proportion of patients who present AEs related to glucose-lowering drugs between baseline and Week 24., From baseline to the end of treatment at 24 weeks|Safety Objective (2): Incidence of Serious Adverse Events (SAEs), To evaluate the percentage of patients who experienced serious adverse events (SAEs) from baseline to Week 24 in each treatment group. This will be measured by comparing the proportion of patients who present SAEs related to glucose-lowering drugs between baseline and Week 24., From baseline to the end of treatment at 24 weeks|Safety Objective (1): Changes in hepatic function, Hepatic function will be assessed by measuring liver enzymes such as GOT, GPT, GGT in U/L., From baseline to the end of treatment at 24 weeks|Safety Objective (2): Changes in renal function (eGFR), Renal function will be assessed by measuring the glomerular filtration rate (eGFR) in mL/min/m²., From baseline to the end of treatment at 24 weeks|Safety Objective (3): Changes in renal function (creatinine), Renal function will be assessed by measuring the levels of creatinine (mg/dl)., From baseline to the end of treatment at 24 weeks|Safety Objective (4): Changes in biochemistry parameters (glucose), This will be assessed by measuring several biochemistry parameters such as glucose (mg/dl)., From baseline to the end of treatment at 24 weeks|Safety Objective (5): Changes in biochemistry parameters (insulin), This will be assessed by measuring several biochemistry parameters such as insulin (mU/L)., From baseline to the end of treatment at 24 weeks|Safety Objective (6): Changes in biochemistry parameters (lipid panel), This will be assessed by measuring several biochemistry parameters such as HDL, LDL and total colesterol in mg/l., From baseline to the end of treatment at 24 weeks|Safety Objective (7): Changes in heart rate, This will be measured by comparing the heart rate (bpm) from baseline to Week 24 for each treatment group., From baseline to the end of treatment at 24 weeks|Safety Objective (8): Changes in blood pressure, This will be measured by comparing the blood pressure (mmHg) from baseline to Week 24 for each treatment group., From baseline to the end of treatment at 24 weeks
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| Locations: |
Hospital Universitario Regional de Málaga, Málaga, 29010, Spain|Hospital Clínico Universitario de Valencia, Valencia, 46010, Spain|Hospital General Universitario de Valencia (HGUV), Valencia, 46014, Spain|Hospital Universitario Rio Hortega de Valladolid (HURH), Valladolid, 47012, Spain
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