Use of Incretins in Diabetic Patients
Observational Study on the Use of Incretins in Diabetic Patients: Evaluation of Metabolic Effects and Cardiovascular Events
1 other identifier
observational
2,234
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2018
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 27, 2018
CompletedStudy Start
First participant enrolled
March 27, 2018
CompletedFirst Posted
Study publicly available on registry
April 3, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
May 30, 2021
CompletedMay 24, 2022
May 1, 2022
2.8 years
March 27, 2018
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
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
Eligibility Criteria
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
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