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Completed

NCT Number: NCT03486964

Use of Incretins in Diabetic Patients

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS Policlinico San Matteo Foundation

Pavia, Lombardy, 27100, Italy

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DPP-4 inhibitors

Drug

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

Primary outcomes

  1. Glycated hemoglobin

    Time frame: 8 years

    Percentage

  2. Fasting plasma glucose

    Time frame: 8 years

    mg/dl

  3. Post-prandial plasma glucose

    Time frame: 8 years

    mg/dl

Secondary outcomes

  1. Angina pectoris

    Time frame: 8 years

    Percentage

  2. Extrasystoles

    Time frame: 8 years

    Percentage

  3. Atrial fibrillation

    Time frame: 8 years

    Percentage

  4. Fatal myocardial infarction

    Time frame: 8 years

    Percentage

  5. Non-fatal myocardial infarction

    Time frame: 8 years

    Percentage

  6. Heart failure

    Time frame: 8 years

    Percentage

  7. Cardiovascular death

    Time frame: 8 years

    Percentage

Sponsors and collaborators

Lead sponsor

University of Pavia

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Apr 3, 2018
Registry last updated
May 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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