Diabetes Mellitus, Type 2NCT03486964
Use of Incretins in Diabetic Patients
An observational study of Diabetes Mellitus, Type 2, run by University of Pavia at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- DPP-4 inhibitors
- How many people
- 2,234 participants
- Where
- 1 siteItaly
- Study dates
- 27 Mar 2018to 30 May 2021
- Phase
- Observational
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients in therapy with DPP-4 inhibitors in addition to sulfonylureas and/or biguanides and/or thiazolidinediones and/or insulin
Who may be able to join
- Type 2 diabetic patients
- On oral hypoglycemic agents ± basal insulin
- In primary and secondary prevention
Who cannot join
- Patients with a follow-up of less than 8 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- DPP-4 inhibitors
- 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.
DPP-4 inhibitorsDrug
Patients will be retrospectively evaluated after the addition of a DPP-4 inhibitor to previously taken anti-diabetic therapy
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycated hemoglobin
Percentage
Measured: 8 years
Fasting plasma glucose
mg/dl
Measured: 8 years
Post-prandial plasma glucose
mg/dl
Measured: 8 years
Secondary outcomes (7)
Angina pectoris
Percentage
Measured: 8 years
Extrasystoles
Percentage
Measured: 8 years
Atrial fibrillation
Percentage
Measured: 8 years
Fatal myocardial infarction
Percentage
Measured: 8 years
Non-fatal myocardial infarction
Percentage
Measured: 8 years
Heart failure
Percentage
Measured: 8 years
Cardiovascular death
Percentage
Measured: 8 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2018
- Study start27 Mar 2018
- Primary completion31 Dec 2020
- Study completion30 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,234 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giuseppe Derosa, University of Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03486964
- Sponsor's protocol ID
- P-20180016468
- Status last verified
- May 2022
- First submitted
- 27 Mar 2018
- Last updated
- 24 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study on the Use of Incretins in Diabetic Patients: Evaluation of Metabolic Effects and Cardiovascular Events
- ClinicalTrials.gov ID
- NCT03486964
- Acronym / sponsor ID
- P-20180016468
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,234 participants (actual)
- Lead sponsor
- University of PaviaUniversity, hospital or other
- Study start
- 27 Mar 2018 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 30 May 2021 (actual)
- First posted
- 3 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DPP-4 plus other therapies | – | Drug: DPP-4 inhibitorsPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients in therapy with DPP-4 inhibitors in addition to sulfonylureas and/or biguanides and/or thiazolidinediones and/or insulin
Key inclusion criteria (3 listed)
- Type 2 diabetic patients
- On oral hypoglycemic agents ± basal insulin
- In primary and secondary prevention
Key exclusion criteria (1 listed)
- Patients with a follow-up of less than 8 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DPP-4 inhibitorsPatients will be retrospectively evaluated after the addition of a DPP-4 inhibitor to previously taken anti-diabetic therapy | Drug | DPP-4 plus other therapies |
Primary outcome
Glycated hemoglobin
Time frame: 8 years
Percentage
Fasting plasma glucose
Time frame: 8 years
mg/dl
Post-prandial plasma glucose
Time frame: 8 years
mg/dl
7 secondary outcomes
Angina pectoris
Time frame: 8 years
Extrasystoles
Time frame: 8 years
Atrial fibrillation
Time frame: 8 years
Fatal myocardial infarction
Time frame: 8 years
Non-fatal myocardial infarction
Time frame: 8 years
Heart failure
Time frame: 8 years
Cardiovascular death
Time frame: 8 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 2, run by University of Pavia 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 3 inclusion and 1 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: finished, as of the sponsor's last update on 24 May 2022. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycated hemoglobin (time frame: 8 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 May 2022.