Impact of Pharmacogenetic-Guided Treatment on Type 2 Diabetes.

Sponsor
Fundación para la Investigación del Hospital Clínico de Valencia
Study ID
NCT06851962
Phase
PHASE4
Status
Active Not Recruiting

Conditions

  • Diabetes Mellitus Type 2

Eligibility Criteria

Sex
ALL
Age
40 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

The goal of this clinical trial is to assess the efficacy of a pharmacogenetics-guided treatment, compared to standard optimized treatment, in patients with inadequately controlled type 2 diabetes. The main questions it aims to answer are: * Is the disease better controlled when the treatment prescribed is based on the participant's pharmacogenetic profile? * What medical problems do participants experience while taking the treatment? Participants will: * Take the treatment described according to the Summary of Product Characteristics (SmPC). * Visit the clinic once every 12 weeks for checkups and tests. * Keep a diary of their symptoms to inform the Investigator.

Key Dates

Start date
May 26, 2025
Status verified
Feb 2026
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
504 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Pharmacogenetic-guided treatment
    Patient treatment will be selected according to previously identified genetic variations. Study treatments and posology from enrollment to the end of treatment at Week 24 can be: 1. Metformin (daily dose 2000 mg). 2. GLP1 receptor analogs: dulaglutide and semaglutide. 3. SGLT2 inhibitors: empagliflozin, canagliflozin and dapagliflozin. 4. Pioglitazone. 5. DPP4 inhibitors: sitagliptin, vildagliptin and linagliptin. Or a combination of these drugs. Except of metformin, which 2000 mg is the daily dose stablished in this study, for the rest of treatment options, SmPCs guidelines of each treatment will be followed to stablished the daily dose.
  • Active Comparator: Standard treatment
    Patient treatment will be selected according to clinical guidelines. Study treatments and posology from enrollment to the end of treatment at Week 24 can be: 1. Metformin (daily dose 2000 mg). 2. GLP1 receptor analogs: dulaglutide and semaglutide. 3. SGLT2 inhibitors: empagliflozin, canagliflozin and dapagliflozin. 4. Pioglitazone. 5. DPP4 inhibitors: sitagliptin, vildagliptin and linagliptin. Or a combination of these drugs. Except of metformin, which 2000 mg is the daily dose stablished in this study, for the rest of treatment options, SmPCs guidelines of each treatment will be followed to stablished the daily dose.

Primary Outcome Measure

Comparison of HbA1c ≤7% goal at Week 24 between Pharmacogenetic-Guided and Standard Treatment in Type 2 Diabetes [ Time Frame: From baseline to the end of treatment at 24 weeks ]

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