Use of Incretins in Diabetic Patients

May 21, 2022 updated by: Giuseppe Derosa, University of Pavia

Observational Study on the Use of Incretins in Diabetic Patients: Evaluation of Metabolic Effects and Cardiovascular Events

Observational, retrospective study, conducted in diabetic patients aimed to evaluate the effects on the glyco-metabolic control and on cardiovascular events of different DPP-4 inhibitors. Patients will be stratified in patients taking different DPP-4 in addition to sulfonylureas, biguanides, thiazolidinediones, insulin, compared to those in therapy with other hypoglycemic classes, such as sulphonylureas, biguanides, thiazolidinediones, insulin, alone or in combination, in primary and secondary prevention.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

2234

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Lombardy
      • Pavia, Lombardy, Italy, 27100
        • irccs policlinico san matteo foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients in therapy with DPP-4 inhibitors in addition to sulfonylureas and/or biguanides and/or thiazolidinediones and/or insulin

Description

Inclusion Criteria:

  • Type 2 diabetic patients
  • On oral hypoglycemic agents ± basal insulin
  • In primary and secondary prevention

Exclusion Criteria:

- Patients with a follow-up of less than 8 years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
DPP-4 plus other therapies
Patients in therapy with DPP-4 inhibitors in addition to sulfonylureas and/or biguanides and/or thiazolidinediones and/or insulin
Drug: DPP-4 inhibitors
Patients will be retrospectively evaluated after the addition of a DPP-4 inhibitor to previously taken anti-diabetic therapy
Other therapies
Patients in therapy with other hypoglycemic classes, such as sulphonylureas and/or biguanides and/or thiazolidinediones and/or insulin.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glycated hemoglobin
Time Frame: 8 years
Percentage
8 years
Fasting plasma glucose
Time Frame: 8 years
mg/dl
8 years
Post-prandial plasma glucose
Time Frame: 8 years
mg/dl
8 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Angina pectoris
Time Frame: 8 years
Percentage
8 years
Extrasystoles
Time Frame: 8 years
Percentage
8 years
Atrial fibrillation
Time Frame: 8 years
Percentage
8 years
Fatal myocardial infarction
Time Frame: 8 years
Percentage
8 years
Non-fatal myocardial infarction
Time Frame: 8 years
Percentage
8 years
Heart failure
Time Frame: 8 years
Percentage
8 years
Cardiovascular death
Time Frame: 8 years
Percentage
8 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pavia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 27, 2018

Primary Completion (Actual)

December 31, 2020

Study Completion (Actual)

May 30, 2021

Study Registration Dates

First Submitted

March 27, 2018

First Submitted That Met QC Criteria

March 27, 2018

First Posted (Actual)

April 3, 2018

Study Record Updates

Last Update Posted (Actual)

May 24, 2022

Last Update Submitted That Met QC Criteria

May 21, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P-20180016468

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetes Mellitus, Type 2

Clinical Trials on DPP-4 inhibitors

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Tanzania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe