Efficacy of Metformin Versus Sitagliptin on Benign Thyroid Nodules in Type 2 Diabetes (NCT04298684) | Clinical Trial Compass
UnknownPhase 4
Efficacy of Metformin Versus Sitagliptin on Benign Thyroid Nodules in Type 2 Diabetes
France, Guadeloupe, Reunion90 participantsStarted 2021-01-01
Plain-language summary
A 2-years prospective, randomized and multicentric study will be performed to assess the efficacy of metformin compared to sitagliptin on benign thyroid nodules size ≥ 2 cm, in newly diagnosed patients with type 2 diabetes.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients with T2DM aged 18 to 65 years;
* Uncomplicated T2DM, evolving for less than 3 years;
* Patients with HbA1c levels between 7 and 8% (after the run-in period)
* Patients with at least one TN ≥ 2 cm non-cystic, whose benignity will be confirmed by a fine-needle aspiration cytology performed twice regardless of ultrasound TIRADS score;
* Naive subjects of any treatment: never received an anti-diabetic treatment OR received an anti-diabetic treatment of less than 30 days since diagnosis OR did not receive an anti-diabetic treatment during the 30 days before screening;
* Patients with a creatinine clearance \> 60 ml/min;
* Informed and written consent signed by the patient and the investigator;
* Affiliation to the national social health system or equivalent.
Exclusion Criteria:
* Subjects without adequate or impaired decisional abilities for consent to research and placed under guardianship, trusteeship or safeguard of justice
* Pregnant or breastfeeding woman
* Woman of childbearing potential without effective contraception (estroprogestative, presentative, intrauterine device)
* Suspect thyroid nodules in ultrasound (TIRADS 4 to 5) with confirmation after a fine-needle aspiration cytology;
* Thyroid function abnormalities or a history of thyroid disease;
* Thyroid nodules whose size or symptoms (compressive signs) require surgery
* Ioduria \<100ug /L
* Thyroid autoimmunity: positive anti-peroxidase, thyroglobulin or anti-TSH receptors antibodies…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of patients in each group who had at least a 20% decrease in one or more nodules of more than 2 cm at 2 years.
Timeframe: 24 months
Trial details
NCT IDNCT04298684
SponsorCentre Hospitalier Universitaire de la Guadeloupe