Efficacy of Metformin Versus Sitagliptin on Benign Thyroid Nodules in Type 2 Diabetes

• Status: Not yet recruiting
• Trial end date: 2024-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Hospitalier Universitaire de Pointe-a-Pitre
• Treatments: Metformin; Sitagliptin Phosphate

Criteria

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