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Diabetes Mellitus, Type 2Phase 4INF-DM2-TherNCT04392557

Anti-inflammatory Status in DM2 Treated Patients

A Phase 4 study testing Metformin / alogliptin Oral Product, Metformin / Pioglitazone Pill and triple therapy in people with Diabetes Mellitus, Type 2, run by University of Catanzaro at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 35 to 75 years
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
Metformin / alogliptin Oral Product, Metformin / Pioglitazone Pill and triple therapy
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteItaly
Study dates
1 Jul 2020to 20 Jun 2021
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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)
Show all 10Show fewer
  • Active bladder cancer or history of bladder cancer
  • macroscopic haematuria of unidentified nature
  • hypersensitivity to drug used (metformin, alogliptin, pioglitazone)
  • breastfeeding

Trial locations and contacts

1 site in 1 country.

Italy1 site, 1 recruiting

  • ASP Catanzaro

    Catanzaro, 88100

    Antonio Guerra, MD, 3398199190, guerra.antonio@simg.it

    Antonio Scuteri, MD

    Recruiting

Other trials in Italy

About this study

Official title: Comparison of Anti-inflammatory Status Linked to Atherosclerosis Formation/Progression Among Diabetes Mellitus Type 2 Patients Under Combined Pharmacological Therapy

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

Read the 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

Being tested
Metformin / alogliptin Oral Product, Metformin / Pioglitazone Pill, triple therapy
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Metformin / alogliptin Oral ProductDrug

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

  • Metformin / Pioglitazone PillDrug

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

  • triple therapyDrug

    Metformin / Alogliptin/ Pioglitazone

Study groups in NCT04392557
Study groupRoleWhat they receive
metformin/alogliptinActive comparatormetformin/alogliptin (850 mg/12.5 mg or 1000 mg/12.5 mg every 12 hours) for 12 months
Receives: Drug: Metformin / alogliptin Oral Product
metformin/pioglitazoneActive comparatormetformin/pioglitazone (850 mg/15 mg every 12 hours) for 12 months
Receives: Drug: Metformin / Pioglitazone Pill
triple therapyActive comparatormetformin/pioglitazone (850 mg/15 mg every 12 hours)+alogliptin (12.5 mg every 12 hours) for 12 months
Receives: Drug: Metformin / alogliptin Oral Product; Drug: Metformin / Pioglitazone Pill; Drug: triple therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. inflammatory miRNA

    Change from Baseline at 12 months

    Measured: 12 months

  2. 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

    Measured: 12 months

Secondary outcomes (8)

  1. body weight

    effects of each treatment on body mass index (kg/m^2) (as indirect indexes of systemic inflammation and visceral adiposity).

    Measured: 12 months

  2. Waist values

    effects of each treatment on waist values (cm) (as indirect indexes of systemic inflammation and visceral adiposity).

    Measured: 12 months

  3. drug interaction

    statistically significant difference (P<0.05) in the development of drug-drug interactions, recorded using the DIPS scale

    Measured: 12 months

  4. Fasting blood glucose

    effects of each treatment on fasting blood glucose (mg/dL) (as indexes of glucose metabolism);

    Measured: 12 months

  5. HbA1c levels

    effects of each treatment on HbA1c levels (percent) (as indexes of glucose metabolism);

    Measured: 12 months

  6. liver function

    alanine aminotransferase, aspartate aminotransferase, gamma glutamyl-transpeptidase levels, and total bilirubin levels (expressed as mg/dL) (as indexes of liver function).

    Measured: 12 months

  7. cell count

    effects of each treatment on white blood cell count expressed as cell/mm3 (as direct index of systemic inflammation)

    Measured: 12 months

  8. lipid metabolism/atheroscelorisis

    total cholesterol, HDL cholesterol, LDL cholesterol and triglycerides levels (expressed as mg/dL) (as direct indexes of lipid metabolism and atheroscelorisis).

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 May 2020
  2. Study start1 Jul 2020
  3. Primary completion1 Sep 2020
  4. Study completion20 Jun 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
single center single blind study
Masking
Single blind
Who is masked
Investigator
Enrolment
36 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04392557
Sponsor's protocol ID
Inflammation-DM2
Acronym
INF-DM2-Ther
Status last verified
Sep 2020
First submitted
4 May 2020
Last updated
16 Sep 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Metformin / alogliptin Oral Product, Metformin / Pioglitazone Pill and triple therapy in people with Diabetes Mellitus, Type 2, run by University of Catanzaro at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 16 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

inflammatory miRNA (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04392557.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2020.

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