Anti-inflammatory Status in DM2 Treated Patients

NCT ID: NCT04392557

Last Updated: 2020-09-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-01
• Study Completion Date: 2021-06-20

Brief Summary

Diabetes mellitus Type 2 (DMT2) - a progressive insulin secretory defect on the background of insulin resistance - is one of the major risk factors for atherosclerosis, an inflammatory disease of the arterial wall, in which leukocytes and oxidized lipoproteins accumulate leading to formation of fatty streaks and atherosclerotic plaques. Atherosclerosis accounts for more than 600,000 deaths annually in the U.S. mainly due to acute myocardial infarction and stroke. Pharmacological therapy of DMT2 includes several drugs used as monotherapy, although combination therapy between metfomin plus thiazolidinediones (TZD) and/or dipeptidyl-peptidase 4 inhibitors (DPP4I) plus TDZ, may delay atherosclerosis progression even if the molecular mechanisms are not clear. Even if normoglycemia is achieved, DMT2 patients still displayed a higher risk for developing atherosclerosis suggesting that other mechanisms of the inflammatory status are involved

Detailed Description

Diabetes mellitus Type 2 (DMT2) - a progressive insulin secretory defect on the background of insulin resistance - is one of the major risk factors for atherosclerosis, an inflammatory disease of the arterial wall, in which leukocytes and oxidized lipoproteins accumulate leading to formation of fatty streaks and atherosclerotic plaques. Atherosclerosis accounts for more than 600,000 deaths annually in the U.S. mainly due to acute myocardial infarction and stroke. Pharmacological therapy of DMT2 includes several drugs used as monotherapy, although combination therapy between metfomin plus thiazolidinediones (TZD) and/or dipeptidyl-peptidase 4 inhibitors (DPP4I) plus TDZ, may delay atherosclerosis progression even if the molecular mechanisms are not clear . Even if normoglycemia is achieved, DMT2 patients still displayed a higher risk for developing atherosclerosis suggesting that other mechanisms of the inflammatory status are involved

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

metformin/alogliptin

metformin/alogliptin (850 mg/12.5 mg or 1000 mg/12.5 mg every 12 hours) for 12 months

Group Type: ACTIVE_COMPARATOR

Metformin / alogliptin Oral Product

Intervention Type: DRUG

850 or 1000 mg/ 12.5 mg every 12 hours for 12 months

metformin/pioglitazone

metformin/pioglitazone (850 mg/15 mg every 12 hours) for 12 months

Group Type: ACTIVE_COMPARATOR

Metformin / Pioglitazone Pill

Intervention Type: DRUG

(850 mg/15 mg every 12 hours) for 12 months

triple therapy

metformin/pioglitazone (850 mg/15 mg every 12 hours)+alogliptin (12.5 mg every 12 hours) for 12 months

Group Type: ACTIVE_COMPARATOR

Metformin / alogliptin Oral Product

Intervention Type: DRUG

850 or 1000 mg/ 12.5 mg every 12 hours for 12 months

Metformin / Pioglitazone Pill

Intervention Type: DRUG

(850 mg/15 mg every 12 hours) for 12 months

triple therapy

Intervention Type: DRUG

Metformin / Alogliptin/ Pioglitazone

Interventions

Metformin / alogliptin Oral Product

850 or 1000 mg/ 12.5 mg every 12 hours for 12 months

Intervention Type: DRUG

Metformin / Pioglitazone Pill

(850 mg/15 mg every 12 hours) for 12 months

Intervention Type: DRUG

triple therapy

Metformin / Alogliptin/ Pioglitazone

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• DMT2 patients were enrolled in presence of

1. Age >35 and <75 years old

2. Uncontrolled diabetes during treatment (glycosylated hemoglobin (HbA1c) > 75 mmol/mol )

3. Combined therapy at least by 6 months.

Exclusion Criteria

1. HbA1c < 75 mmol/mol (9%);

2. History of drug abuse or alcohol abuse, averaging more than 30 gm/day (3 drinks per day) in the previous 10 years, or history of alcohol intake averaging greater than 10 gm/day (1 drink per day: 7 drinks per week) in the previous one year;

3. Estimated glomerular filtration rate (GFR) <30 ml/min (according to MDRD formula)

4. .Liver Failure

5. Recent history of Heart stroke, systemic infections, dehydration, lactic acidosis

6. Heart failure (NYHA I - IV)

7. Active bladder cancer or history of bladder cancer

8. macroscopic haematuria of unidentified nature

9. hypersensitivity to drug used (metformin, alogliptin, pioglitazone)

10. breastfeeding

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Catanzaro

OTHER

Sponsor Role: lead

Responsible Party

Luca Gallelli

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

ASP Catanzaro

Catanzaro, , Italy

Site Status: RECRUITING

Countries

Italy

Facility Contacts

Antonio Guerra, MD

Role: primary

guerra.antonio@simg.it

3398199190

Other Identifiers

Inflammation-DM2

Identifier Type: -

Identifier Source: org_study_id