Efficacy of Metformin versus sitagliptin on benign thyroid nodules in type 2 diabetes

Phase 1

• Conditions: newly diagnosed subjects with uncomplicated T2DM and begnin TN of at least 2 cm of size, after pregnancy exclusion if women; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2019-000676-42-FR
• Lead Sponsor: niversity Center Hospital of Guadeloupe

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-01-14
• Last Update Posted: 30 January 2023

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 90

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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 90
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Subjects without adequate or impaired decisional abilities for consent to research and placed under guardianship, curatorship 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
- Urinary iodures <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 etc. ...
- Acute conditions that may impair renal function such as: dehydration, severe infection…

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified