Ended Therapeutic use (Phase IV) Type 2 Diabetes Mellitus

Clinical trial to evaluate whether personalized treatment based on genetics improves type 2 diabetes control

EU CTIS ID: 2025-520686-46-00

What this study is testing

To evaluate the efficacy of pharmacogenetic-guided treatment, compared with optimized standard treatment, in subjects with insufficiently controlled type 2 diabetes.

  • Therapeutic use (Phase IV)

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

  • Age 40-70 years old, included.
  • Body Mass Index (BMI) 25-40 kg/m².
  • Diagnosis of T2D according to the American Diabetes Association (ADA) criteria.
  • 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.
  • Subject has provided written informed consent prior to any study specific procedure.
  • Able and willing to comply with requested study visits and procedures.

You likely can't join if

  • Treatment with insulin at the time of screening.
  • 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.
  • Subject is staff personal directly involved with the study or is a family member of the investigational study staff.
  • Life expectancy predicted to be <2 years.
  • HbA1c >9.5% at screening.
  • Treatment with more than 3 glucose lowering drugs at the time of screening.
See the full eligibility criteria
Who can join
  • Age 40-70 years old, included.
  • Body Mass Index (BMI) 25-40 kg/m².
  • Diagnosis of T2D according to the American Diabetes Association (ADA) criteria.
  • 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.
  • Subject has provided written informed consent prior to any study specific procedure.
  • Able and willing to comply with requested study visits and procedures.
  • Contraceptive measures, only for female participants: • A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies: - Is a woman of nonchildbearing potential (WONCBP) OR - Is 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.
What rules you out
  • Treatment with insulin at the time of screening.
  • 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.
  • Subject is staff personal directly involved with the study or is a family member of the investigational study staff.
  • Life expectancy predicted to be <2 years.
  • HbA1c >9.5% at screening.
  • Treatment with more than 3 glucose lowering drugs at the time of screening.
  • 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.
  • Hepatic insufficiency which contraindicates the use of glucose-lowering drugs.
  • Currently receiving treatment in another investigational drug study, or less than 30 days since ending treatment on another investigational drug study.
  • Pregnancy or lactation.
  • Women of child bearing potential with no effective contraceptive methods.
  • New York Heart Association (NYHA) Class III or IV congestive heart failure.

The study team makes the final eligibility decision.

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.

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.