Clinical trial · Interventional
Efficacy of Metformin Versus Sitagliptin on Benign Thyroid Nodules in Type 2 Diabetes
Efficacy of Metformin Versus Sitagliptin on Benign Thyroid Nodules Size in Type 2 Diabetes: a 2-years Prospective Multicentric Study
NCT04298684CI-TRIAL-00047113METNODTHYRunknownPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Diabetes Mellitus, Type 2 | — | UNRESOLVED | — |
| Thyroid Nodule (Benign) | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| METFORMIN | Drug | Metformin | ALIAS |
| Sitagliptin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Metformin
- description
- In arm 1, the subjects will receive metformin at the initial dose of 500mg x 2 / day, which will be increased weekly to 500mgx3 / day and then 1gx2 / day in order to obtain the minimum effective dose on glycemic control.
- interventionNames
- Drug: METFORMIN
- type
- PLACEBO_COMPARATOR
- label
- Sitagliptin
- description
- In arm 2, sitagliptin will be prescribed at 100mg / day. A classic follow-up will be done every 3 months.
- interventionNames
- Drug: Sitagliptin
Primary outcomes (1)
- measure
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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 * Levothyroxine treatment * History of cervical radiotherapy or thyroid surgery * Type 1 diabetes * Insulin deficiency * History of hypersensitivity to one of the active substances * History of pancreatitis * Obesity linked to endocrine disease * Presence of severe complications of T2DM (ischemic heart disease, heart failure with reduced left ventricular ejection fraction, severe lower extremity arteritis, gangrene, retinopathy, end-stage renal failure, cerebrovascular accident) * HbA1c levels \> 8% after the run-in period * Liver diseases (liver failure, cirrhosis, viral hepatitis B or C) * Acute alcoholic intoxication, chronic alcoholism * Psychiatric diseases (depression, schizophrenia) * Neurological diseases (epilepsy, demyelinating diseases, etc.) * Treatment influencing the morphology or thyroid function: corticosteroids, lithium, iodized products etc. ... * Acute conditions that may impair renal function such as: dehydration, severe infection, shock * Respiratory failure * Metabolic acidosis
References
Publications (24)
- BACKGROUNDAnil C, Akkurt A, Ayturk S, Kut A, Gursoy A. Impaired glucose metabolism is a risk factor for increased thyroid volume and nodule prevalence in a mild-to-moderate iodine deficient area. Metabolism. 2013 Jul;62(7):970-5. doi: 10.1016/j.metabol.2013.01.009. Epub 2013 Feb 5. PMID 23395200
- BACKGROUNDAyturk S, Gursoy A, Kut A, Anil C, Nar A, Tutuncu NB. Metabolic syndrome and its components are associated with increased thyroid volume and nodule prevalence in a mild-to-moderate iodine-deficient area. Eur J Endocrinol. 2009 Oct;161(4):599-605. doi: 10.1530/EJE-09-0410. Epub 2009 Jul 24. PMID 19633072
- BACKGROUNDBarbesino G. Drugs affecting thyroid function. Thyroid. 2010 Jul;20(7):763-70. doi: 10.1089/thy.2010.1635. PMID 20578900
- BACKGROUNDBonnet F, Scheen A. Understanding and overcoming metformin gastrointestinal intolerance. Diabetes Obes Metab. 2017 Apr;19(4):473-481. doi: 10.1111/dom.12854. Epub 2017 Feb 22. PMID 27987248
- BACKGROUNDChen G, Xu S, Renko K, Derwahl M. Metformin inhibits growth of thyroid carcinoma cells, suppresses self-renewal of derived cancer stem cells, and potentiates the effect of chemotherapeutic agents. J Clin Endocrinol Metab. 2012 Apr;97(4):E510-20. doi: 10.1210/jc.2011-1754. Epub 2012 Jan 25. PMID 22278418
- BACKGROUNDClemmons DR. Structural and functional analysis of insulin-like growth factors. Br Med Bull. 1989 Apr;45(2):465-80. doi: 10.1093/oxfordjournals.bmb.a072335. PMID 2480830
- BACKGROUNDAmerican Thyroid Association (ATA) Guidelines Taskforce on Thyroid Nodules and Differentiated Thyroid Cancer; Cooper DS, Doherty GM, Haugen BR, Kloos RT, Lee SL, Mandel SJ, Mazzaferri EL, McIver B, Pacini F, Schlumberger M, Sherman SI, Steward DL, Tuttle RM. Revised American Thyroid Association management guidelines for patients with thyroid nodules and differentiated thyroid cancer. Thyroid. 2009 Nov;19(11):1167-214. doi: 10.1089/thy.2009.0110.