Status:
COMPLETED
Managing DIabetes Remission After Combined Therapy in EarLy Stage of DiabetEs
Lead Sponsor:
Azienda Ospedaliero-Universitaria di Parma
Conditions:
Newly Diagnosed Type 2 Diabetes
Eligibility:
All Genders
35-75 years
Phase:
PHASE3
Brief 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 ...
Detailed Description
Hypothesis: at diagnosis of T2DM, a 4 month course of oral polychemotherapy (POLYCHEM), by engaging multiple glucose lowering mechanisms, results into euglycemia and, after suspension, in T2DM remissi...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
September 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2024
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT04271189
Start Date
September 1 2020
End Date
December 31 2024
Last Update
March 18 2025
Active Locations (1)
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1
Azienda Ospedaliero Universitaria di Parma
Parma, Parma, Italy, 43126