NCT04271189CompletedPhase 3
Managing DIabetes Remission After Combined Therapy in EarLy Stage of DiabetEs
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.
Source: ClinicalTrials.gov · Last updated 18 Mar 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 108 (actual)
- First submitted
- 15 Oct 2019
- Start date
- 1 Sept 2020
- Primary completion date
- 31 Aug 2024
- Lead sponsor
- Azienda Ospedaliero-Universitaria di Parma
- Diseases
- Type 2 diabetes
- NCT number
- NCT04271189
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 108
- From 1 Sept 2020 to the primary completion date, 31 Aug 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Acute cardiovascular event within the previous 6 months;
- Contraindications to the use of any drug of POLYCHEM.
Other illness
- Diagnosis of type 1 diabetes;
- History of cancer in the previous 5 years;
- Chronic heart failure;
Lab values
- eGFR \< 45 ml.min-1.1.73 m2 according to the MDRD formula;
Other
- Multiple daily insulin treatment;
- Women of child bearing potential with no use of acceptable contraception;
- Presence of diabetic retinopathy;
Who the study is looking for
- 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.
Age in the registry: 35 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Azienda Ospedaliero Universitaria di Parma Coordinator of this site? Confirm its status | Parma | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.