Anti-inflammatory Status in DM2 Treated Patients

NCT04392557 | Unknown Phase 4

• 1 other identifier: Inflammation-DM2
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (2)

• inflammatory miRNA

  Change from Baseline at 12 months

  12 months

• side effects

  statistically significant difference (P\<0.05) in the development of side effects between the groups, recorded using the Naranjo adverse drug reactions scale

  12 months

Secondary Outcomes (8)

• body weight

  12 months

• Waist values

  12 months

• drug interaction

  12 months

• Fasting blood glucose

  12 months

• HbA1c levels

  12 months

Study Arms (3)

metformin/alogliptin

ACTIVE COMPARATOR

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

Drug: Metformin / alogliptin Oral Product

metformin/pioglitazone

ACTIVE COMPARATOR

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

Drug: Metformin / Pioglitazone Pill

triple therapy

ACTIVE COMPARATOR

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

Drug: Metformin / alogliptin Oral Product; Drug: Metformin / Pioglitazone Pill; Drug: triple therapy

Interventions

Metformin / alogliptin Oral Product DRUG

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

metformin/alogliptin; triple therapy

Metformin / Pioglitazone Pill DRUG

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

metformin/pioglitazone; triple therapy

triple therapy DRUG

Metformin / Alogliptin/ Pioglitazone

triple therapy

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• DMT2 patients were enrolled in presence of
• Age \>35 and \<75 years old
• Uncontrolled diabetes during treatment (glycosylated hemoglobin (HbA1c) \> 75 mmol/mol )
• Combined therapy at least by 6 months.

You may not qualify if:

• HbA1c \< 75 mmol/mol (9%);
• 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;
• Estimated glomerular filtration rate (GFR) \<30 ml/min (according to MDRD formula)
• Liver Failure
• Recent history of Heart stroke, systemic infections, dehydration, lactic acidosis
• Heart failure (NYHA I - IV)
• Active bladder cancer or history of bladder cancer
• macroscopic haematuria of unidentified nature
• hypersensitivity to drug used (metformin, alogliptin, pioglitazone)
• breastfeeding

Sponsors & Collaborators

• University of Catanzaro: lead

Study Sites (1)

ASP Catanzaro

Catanzaro, 88100, Italy

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Metformin; Pioglitazone

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Thiazolidinediones; Thiazoles; Sulfur Compounds; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: single center single blind study

Study Record Dates

• First Submitted: May 4, 2020
• First Posted: May 19, 2020
• Study Start: July 1, 2020
• Primary Completion: September 1, 2020
• Study Completion: June 20, 2021
• Last Updated: September 16, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)