Clinical trial
A Prospective, Randomized, Parallel-group, Adaptive Design Phase IIb/III, Multicenter Study, to Assess the Efficacy of Polychemotherapy for Inducing Remission of Newly Diagnosed Type 2 Diabetes.
Name
2018-833-12
Description
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.
Trial arms
Trial start
2020-09-01
Estimated PCD
2024-03-02
Trial end
2024-05-31
Status
Active (not recruiting)
Phase
Early phase I
Treatment
Metformin-Sitagliptin-Empaglifozin-Pioglitazone
1000 mg metformin (extended release) b.i.d., pioglitazone 15 mg b.i.d., sitagliptin 100 mg q.d., empaglifozin 10 mg q.d..
Arms:
POLYCHEM
Other names:
POLYCHEM
Standard of care
Usual medical care to treat diabetes.
Arms:
STANDARD CARE
Other names:
SDC
Size
180
Primary endpoint
Assess the T2DM remission rate in patients with newly diagnosed T2DM treated with either POLYCHEM or with SDC for 16 weeks.
12 weeks after the end of treatment
Eligibility 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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Multicenter, open label pragmatic phase IIb/III RCT with a duration of 3 years', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 180, 'type': 'ESTIMATED'}}
Updated at
2023-07-20
1 organization
2 products
1 indication
Organization
Azienda Ospedaliero-Universitaria di ParmaIndication
Type 2 DiabetesProduct
Standard of Care