Managing DIabetes Remission After Combined Therapy in EarLy Stage of DiabetEs

• Status: Recruiting
• Trial end date: 2023-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Epidemiologic, social and economic burdens of type 2 diabetes mellitus (T2DM) keep rising worldwide. Implementation of T2DM preventive trategies is lagging behind. Metabolic surgery, very low calorie diet can induce T2DM remission, but so far for few patients. The investigators will assess the efficacy to cause T2DM remission (primary end point) and direct costs to the National Health System of a 4-month polychemotherapy (metformin+pioglitazone+sitagliptin+empagliflozin) regimen vs standard care in patients with newly diagnosed T2DM by an open label, pragmatic RCT. Mechanisms of action will be investigated in a sub-cohort by a prolonged OGTT plus dual tracer technique and modeling of beta cell function.

If proved efficacious in this proof-of-concept study and inducer of durable remission in the future, T2DM polychemotherapy will turn out to be a convenient, relatively unexpensive strategy to restrain prevalence of T2DM and its complications and to alleviate its personal, social and economic burden.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Azienda Ospedaliero-Universitaria di Parma
• Treatments: Metformin; Pioglitazone; Sitagliptin Phosphate

Criteria

Inclusion criteria:

• Age 35-75 years;

• HbA1c <= 10.0% (86 mmol/mol);

• T2DM diagnosis (< 6 months)

• BMI>=23 and <=40 kg/m2

• Fasting C-peptide > 0.3 nmol/l;

• GAD-antibody negative.

Exclusion criteria:

• Diagnosis of type 1 diabetes;

• History of cancer in the previous 5 years;

• Multiple daily insulin treatment;

• Acute cardiovascular event within the previous 6 months;

• Chronic heart failure;

• eGFR < 45 ml.min-1.1.73 m2 according to the MDRD formula;

• Women of child bearing potential with no use of acceptable contraception;

• Presence of diabetic retinopathy;

• Contraindications to the use of any drug of POLYCHEM.