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NCT Number: NCT06120556

Efficacy of Glucagon-like Peptide-1 Receptor Agonists According to Type 2 Diabetes Subtypes

The goal of this observational retrospective study is to understand whether glucagon-like peptide-1 receptor agonists (GLP-1RA), which are a group of antidiabetes drugs, may act differently in different subtypes of patients with type 2 diabetes.

The main questions it aims to answer are:

* people with type 2 diabetes belonging to specific subtypes respond better (or worse) to GLP-1RA? * the beneficial effect of GLP-1RA may last longer in people with type 2 diabetes belonging to specific subtypes? * what are the clinical characteristics that better explain the efficacy and durability of GLP-1 receptor agonists in type 2 diabetes management?

Clinical data from records of patients attending the diabetes outpatient clinic of our facility will be retrieved to compare the outcomes of GLP-1 receptor agonists in patients belonging to four subtypes of type 2 diabetes.

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Azienda Ospedaliero-Universitaria Policlinico Bari

Bari, 70124, Italy

About this study

Patients with type 2 diabetes are all characterized by hyperglycemia, however their probability to develop micro- and micro-vascular complications. A classification of adult-onset diabetes in 5 subtypes was recently proposed: severe autoimmune diabetes (SAID - including type 1 diabetes and latent autoimmune diabetes in adults LADA), severe insulin resistant diabetes (SIRD), severe insulin deficient diabetes (SIDD), mild age related diabetes (MARD), mild obesity-related diabetes (MOD). This classification has been validated in a multiple populations of patients with recent onset diabetes (within 5 years).

However, this classification requires the measurement of c-peptide/insulinemia or anti- glutamic acid decarboxylase (GAD) antibodies, limiting its applicability in everyday clinical practice. An alternative algorithm requiring easily available clinical characteristics, such as BMI, height, waist circumference, HbA1c, fasting blood glucose, lipid profile, age and age at diagnosis was recently introduced and validated.

In this retrospective observational study, the calculated sample size was of 128 patients, in 4 groups, with alpha 0.05, 1-beta 0.80, effect size 0.3.

The following data will be retrieved for eligible patients: age, sex, diabetes duration, age at diagnosis, antidiabetes therapy, body weight, height, waist circumference, fasting blood glucose, HbA1c, total and HDL and LDL cholesterol, triglycerides, creatinine, microalbuminuria. The algorithm available online (https://uiem.shinyapps.io/diabetes_clusters_app/), will be used to assign enrolled patients to the 4 subtypes of type 2 diabetes (SIDD, SIRD, MARD, MOD).

If available, information regarding micro- and macro-vascular complications of diabetes will be retrieved.

All data will be collected at baseline visit and every follow-up visit (the first follow-up visit should 6-12 months following prescription of a GLP-1 receptor agonist).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Italian patients with type 2 diabetes
  • Onset of diabetes at ≥ 50 years
  • Diagnosis of type 2 diabetes ≤ 5 years from enrollment
  • BMI ≥ 25 kg/m2
  • Patients receiving a GLP-1RA prescription for the first time with at least one follow-up visit at 6-12 months from first prescription

Exclusion criteria

  • Autoimmune diabetes, monogenic diabetes, secondary diabetes
  • History of diabetic ketoacidosis

Treatment and study plan

GLP-1 receptor agonist

Drug

Patients initiating a GLP-1 receptor agonist (i.e. liraglutide, dulaglutide, semaglutide) will be included in the study.

Primary outcomes

  1. Difference in HbA1c change from baseline (%) among SIDD, SIRD, MARD, MOD subtypes

    Time frame: Difference in HbA1c change from baseline will be evaluated at first follow-up visit (occurring 6-12 months from GLP-1RA initiation)

Secondary outcomes

  1. Difference in time to failure among SIDD, SIRD, MARD, MOD subtypes

    Time frame: Difference in time to failure will be assessed up to the last available visit (up to 36 months)

    In patients reaching HbA1c <7% at first follow-up visit, the difference in time to failure (defined as HbA1c equal or above 7%)

  2. Difference in fasting blood glucose change from baseline (mg/dl) among SIDD, SIRD, MARD, MOD subtypes

    Time frame: Difference in fasting blood glucose change from baseline (mg/dl) will be evaluated at first follow-up visit (occurring 6-12 months from GLP-1RA initiation)

    mg/dl

  3. Difference in body weight change from baseline (kg) among SIDD, SIRD, MARD, MOD subtypes

    Time frame: Difference in body weight change from baseline (kg) will be evaluated at first follow-up visit (occurring 6-12 months from GLP-1RA initiation)

    kg

  4. Difference in percentage of patients reaching HbA1c below 7% among SIDD, SIRD, MARD, MOD subtypes

    Time frame: Difference in percentage of patients reaching HbA1c below 7% will be evaluated at first follow-up visit (occurring 6-12 months from GLP-1RA initiation)

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

Other

Registry information

Official study title

Efficacy of Glucagon-like Peptide-1 Receptor Agonists According to Type 2 Diabetes Subtypes: an Italian Monocentric Retrospective Study

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Nov 7, 2023
Registry last updated
Jan 30, 2024

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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