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Anti-inflammatory Status in DM2 Treated Patients (INF-DM2-Ther)

Primary Purpose

Diabetes Mellitus, Type 2

Status
Unknown status
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Metformin / alogliptin Oral Product
Metformin / Pioglitazone Pill
triple therapy
Sponsored by
University of Catanzaro
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2

Eligibility Criteria

35 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • ASP CatanzaroRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

metformin/alogliptin

metformin/pioglitazone

triple therapy

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

inflammatory miRNA
Change from Baseline at 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

Secondary Outcome Measures

body weight
effects of each treatment on body mass index (kg/m^2) (as indirect indexes of systemic inflammation and visceral adiposity).
Waist values
effects of each treatment on waist values (cm) (as indirect indexes of systemic inflammation and visceral adiposity).
drug interaction
statistically significant difference (P<0.05) in the development of drug-drug interactions, recorded using the DIPS scale
Fasting blood glucose
effects of each treatment on fasting blood glucose (mg/dL) (as indexes of glucose metabolism);
HbA1c levels
effects of each treatment on HbA1c levels (percent) (as indexes of glucose metabolism);
liver function
alanine aminotransferase, aspartate aminotransferase, gamma glutamyl-transpeptidase levels, and total bilirubin levels (expressed as mg/dL) (as indexes of liver function).
cell count
effects of each treatment on white blood cell count expressed as cell/mm3 (as direct index of systemic inflammation)
lipid metabolism/atheroscelorisis
total cholesterol, HDL cholesterol, LDL cholesterol and triglycerides levels (expressed as mg/dL) (as direct indexes of lipid metabolism and atheroscelorisis).

Full Information

First Posted
May 4, 2020
Last Updated
September 11, 2020
Sponsor
University of Catanzaro
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1. Study Identification

Unique Protocol Identification Number
NCT04392557
Brief Title
Anti-inflammatory Status in DM2 Treated Patients
Acronym
INF-DM2-Ther
Official Title
Comparison of Anti-inflammatory Status Linked to Atherosclerosis Formation/Progression Among Diabetes Mellitus Type 2 Patients Under Combined Pharmacological Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2020 (Actual)
Primary Completion Date
September 1, 2020 (Actual)
Study Completion Date
June 20, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Catanzaro

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
single center single blind study
Masking
Investigator
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
metformin/alogliptin
Arm Type
Active Comparator
Arm Description
metformin/alogliptin (850 mg/12.5 mg or 1000 mg/12.5 mg every 12 hours) for 12 months
Arm Title
metformin/pioglitazone
Arm Type
Active Comparator
Arm Description
metformin/pioglitazone (850 mg/15 mg every 12 hours) for 12 months
Arm Title
triple therapy
Arm Type
Active Comparator
Arm Description
metformin/pioglitazone (850 mg/15 mg every 12 hours)+alogliptin (12.5 mg every 12 hours) for 12 months
Intervention Type
Drug
Intervention Name(s)
Metformin / alogliptin Oral Product
Intervention Description
850 or 1000 mg/ 12.5 mg every 12 hours for 12 months
Intervention Type
Drug
Intervention Name(s)
Metformin / Pioglitazone Pill
Intervention Description
(850 mg/15 mg every 12 hours) for 12 months
Intervention Type
Drug
Intervention Name(s)
triple therapy
Intervention Description
Metformin / Alogliptin/ Pioglitazone
Primary Outcome Measure Information:
Title
inflammatory miRNA
Description
Change from Baseline at 12 months
Time Frame
12 months
Title
side effects
Description
statistically significant difference (P<0.05) in the development of side effects between the groups, recorded using the Naranjo adverse drug reactions scale
Time Frame
12 months
Secondary Outcome Measure Information:
Title
body weight
Description
effects of each treatment on body mass index (kg/m^2) (as indirect indexes of systemic inflammation and visceral adiposity).
Time Frame
12 months
Title
Waist values
Description
effects of each treatment on waist values (cm) (as indirect indexes of systemic inflammation and visceral adiposity).
Time Frame
12 months
Title
drug interaction
Description
statistically significant difference (P<0.05) in the development of drug-drug interactions, recorded using the DIPS scale
Time Frame
12 months
Title
Fasting blood glucose
Description
effects of each treatment on fasting blood glucose (mg/dL) (as indexes of glucose metabolism);
Time Frame
12 months
Title
HbA1c levels
Description
effects of each treatment on HbA1c levels (percent) (as indexes of glucose metabolism);
Time Frame
12 months
Title
liver function
Description
alanine aminotransferase, aspartate aminotransferase, gamma glutamyl-transpeptidase levels, and total bilirubin levels (expressed as mg/dL) (as indexes of liver function).
Time Frame
12 months
Title
cell count
Description
effects of each treatment on white blood cell count expressed as cell/mm3 (as direct index of systemic inflammation)
Time Frame
12 months
Title
lipid metabolism/atheroscelorisis
Description
total cholesterol, HDL cholesterol, LDL cholesterol and triglycerides levels (expressed as mg/dL) (as direct indexes of lipid metabolism and atheroscelorisis).
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Facility Information:
Facility Name
ASP Catanzaro
City
Catanzaro
ZIP/Postal Code
88100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antonio Guerra, MD
Phone
3398199190
Email
guerra.antonio@simg.it
First Name & Middle Initial & Last Name & Degree
Antonio Scuteri, MD
First Name & Middle Initial & Last Name & Degree
Giacomo Leuzzi, MD
First Name & Middle Initial & Last Name & Degree
Giuseppe Giuliano, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Anti-inflammatory Status in DM2 Treated Patients

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