NCT03486964

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,234

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 27, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

March 27, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 3, 2018

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2021

Completed
Last Updated

May 24, 2022

Status Verified

May 1, 2022

Enrollment Period

2.8 years

First QC Date

March 27, 2018

Last Update Submit

May 21, 2022

Conditions

Outcome Measures

Primary Outcomes (3)

  • Glycated hemoglobin

    Percentage

    8 years

  • Fasting plasma glucose

    mg/dl

    8 years

  • Post-prandial plasma glucose

    mg/dl

    8 years

Secondary Outcomes (7)

  • Angina pectoris

    8 years

  • Extrasystoles

    8 years

  • Atrial fibrillation

    8 years

  • Fatal myocardial infarction

    8 years

  • Non-fatal myocardial infarction

    8 years

  • +2 more secondary outcomes

Study Arms (2)

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

Other therapies

Patients in therapy with other hypoglycemic classes, such as sulphonylureas and/or biguanides and/or thiazolidinediones and/or insulin.

Interventions

Patients will be retrospectively evaluated after the addition of a DPP-4 inhibitor to previously taken anti-diabetic therapy

DPP-4 plus other therapies

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Policlinico San Matteo Foundation

Pavia, Lombardy, 27100, Italy

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Dipeptidyl-Peptidase IV Inhibitors

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Protease InhibitorsEnzyme InhibitorsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesHypoglycemic AgentsPhysiological Effects of Drugs

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 27, 2018

First Posted

April 3, 2018

Study Start

March 27, 2018

Primary Completion

December 31, 2020

Study Completion

May 30, 2021

Last Updated

May 24, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations