Open-label, double-arm, controlled, randomized, multicentre clinical trial to evaluate the impact of pharmacogenetic-guided treatment in patients with insufficiently controlled type 2 diabetes

Conditions

Type 2 Diabetes Mellitus

Brief summary

Proportion of patients achieving goal HbA1c ≤7% at Week 24 in experimental arm versus control arm.

Detailed description

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)., Percentage of patients achieving the goal of dyslipidemia at Week 24: - LDL-C of <70 mg/dL without documented CVD at baseline. - LDL-C of <55 mg/dL with documented CVD at baseline., Percentage of patients achieving the goal of blood pressure (<140/90 mmHg) at Week 24., Number of glucose-lowering drugs’ adverse events reported for each genetic variation identified., Proportion of patients in each group presenting each clinical outcome over the study period: • Adverse 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

Related papers

No related papers found yet.

Interventions

DRUGSitagliptin 50mg Film-coated Tablets

DRUGTrajenta 5 mg film-coated tablets

DRUGPioglitazone Mylan 15 mg compresse

DRUGOzempic 0.5 mg solution for injection in pre-filled pen

DRUGJardiance 10 mg film-coated tablets

DRUGGLUCOPHAGE 1000 mg potahované tablety

DRUGInvokana 100 mg film-coated tablets

DRUGTrulicity 1.5 mg solution for injection in pre-filled pen

DRUGGalvus 50 mg tablets

DRUGForxiga 10 mg film-coated tablets

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Proportion of patients achieving goal HbA1c ≤7% at Week 24 in experimental arm versus control arm.	—

Secondary

Measure	Time frame
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)., Percentage of patients achieving the goal of dyslipidemia at Week 24: - LDL-C of <70 mg/dL without documented CVD at baseline. - LDL-C of <55 mg/dL with documented CVD at baseline., Percentage of patients achieving the goal of blood pressure (<140/90 mmHg) at Week 24., Number of glucose-lowering drugs’ adverse events reported for each genetic variation identified., Proportion of patients in each group presenting each clinical outcome over the study period: • Adverse 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	—

Measure

Time frame

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)., Percentage of patients achieving the goal of dyslipidemia at Week 24: - LDL-C of <70 mg/dL without documented CVD at baseline. - LDL-C of <55 mg/dL with documented CVD at baseline., Percentage of patients achieving the goal of blood pressure (<140/90 mmHg) at Week 24., Number of glucose-lowering drugs’ adverse events reported for each genetic variation identified., Proportion of patients in each group presenting each clinical outcome over the study period: • Adverse 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

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Countries

Spain

Outcome results

None listed