Clinical trial NCT05535322: Real-world Evaluation of GLP-1 Receptor Agonists (GLP-1RA) on Efficacy and Persistence, Adherence and Therapeutic Inertia Among Type 2 Diabetes Adults With Obesity
Official title: Real-world Evaluation of GLP-1 Receptor Agonists (GLP-1RA) on Efficacy and Persistence, Adherence and Therapeutic Inertia Among Type 2 Diabetes Adults With Obesity in the Department of Health of Valencia Clínico-Malvarrosa
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes
Obesity
Lead sponsor: Fundación para la Investigación del Hospital Clínico de Valencia
Sponsor class: OTHER
First posted: 2022-09-10
Enrollment: 26944
Sex: ALL
Minimum age (years): 18
Maximum age (years): 125
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All identified adults with type 2 diabetes registered in the Population Information System (SIP) of the Valencian Community and corresponding to the Valencia Clínico-La Malvarrosa Health Department who were diagnosed before the end of the study period were included. Type 2 diabetes (T2D) diagnosis was defined according to the International Classification of Diseases, Ninth and Tenth Revisions, Clinical Modification (ICD-9-CM, ICD-10-CM) codes.

To exclude temporary treatment effects due to short-term use of the antidiabetic treatments, only individuals in the study groups with at least a 6-month prescription were included in the analyses.

Brief summary: Type 2 diabetes (T2D) is a progressive chronic condition associated with a high morbi-mortality that has a considerable impact on healthcare resources.

Glucagon-like peptide-1 receptor agonists (GLP-1RA) are incretin mimetics that have been shown to improve glycemic control with a low associated risk of hypoglycemia. Additionally, previous studies have linked the use of GLP-1RA with a reduction in the risk of cardiovascular events and kidney disease progression. Despite these positive results, GLP1-RA´s prescription, following the failure of treatment with metformin monotherapy or dual therapy, remains low in Spain compared to other countries in our milieu. Furthermore, the use of this therapeutic class is not homogeneous across the different autonomous communities in Spain, and, no objective justification for these differences seems to exist. Consequently, there is a need to understand which are the benefits associated with the use of GLP-1RA, versus intensification with other oral agents, in real-life conditions.

In this study, the impact of the use of GLP-1RA on clinical outcomes such as all-cause mortality, cardiovascular and renal outcomes as well as severe hypoglycemia will be evaluated based on the analysis of longitudinal databases that collect the variables of interest generated in a real-life scenario. In addition, both persistence and adherence to treatment in patients treated with GLP-1RA and its impact on the clinical outcomes of interest will be studied. Finally, therapeutic inertia will be analyzed.

All these data will contribute to generating cost-effective strategies aimed at improving health outcomes among T2D patients in our setting, reinforcing persistence and adherence to the prescribed treatment, and reducing therapeutic inertia in this group of patients.

Since the use of GLP-1RA versus intensification with other oral agents has been associated with better glycemic control, and, when compared to intensification with basal insulin, with a lower incidence of severe hypoglycemia, we hypothesized that T2D adults treated with GLP-1RA would present a lower incidence of cardiovascular and renal outcomes and fewer hospitalizations due to severe hypoglycemia events as well as a decreased all-cause mortality. On the other hand, patients on GLP-1RA who would present greater persistence and adherence to treatment should experience fewer cardiovascular and renal outcomes and lower mortality compared to those with less persistence and adherence. Finally, it is possible that the type of GLP-1RA and the mode of administration, weekly versus daily, may influence adherence, persistence and therapeutic inertia in this group of patients.


Eligibility criteria: Inclusion Criteria:

* Adults with type 2 diabetes
* Individuals with at least a 6-month prescription

Exclusion Criteria:

* Individuals below 18
* Individuals with less than a 6-month prescription

Primary outcomes:
measure: Major acute cardiovascular events
timeFrame: From inclusion in the study, starting from 01/01/2014, until the event or the end of the study, on 31/12/2019, whichever came first.
Secondary outcomes:
measure: Major acute cardiovascular events without heart failure
timeFrame: From inclusion in the study, starting from 01/01/2014, until the event or the end of the study, on 31/12/2019, whichever came first.
measure: AMI
timeFrame: From inclusion in the study, starting from 01/01/2014, until the event or the end of the study, on 31/12/2019, whichever came first.
measure: Stroke
timeFrame: From inclusion in the study, starting from 01/01/2014, until the event or the end of the study, on 31/12/2019, whichever came first.
measure: Heart Failure
timeFrame: Through study completion (from inclusion in the study until the event or the end of the study period, whichever came first)
measure: all-cause death
timeFrame: From inclusion in the study, starting from 01/01/2014, until the event or the end of the study, on 31/12/2019, whichever came first.
measure: Renal progression
timeFrame: From inclusion in the study, starting from 01/01/2014, until the event or the end of the study, on 31/12/2019, whichever came first.
measure: atrial fibrillation
timeFrame: From inclusion in the study, starting from 01/01/2014, until the event or the end of the study, on 31/12/2019, whichever came first.
measure: Hypoglycemia
timeFrame: From inclusion in the study, starting from 01/01/2014, until the event or the end of the study, on 31/12/2019, whichever came first.
measure: Persistence
timeFrame: From inclusion in the study, starting from 01/01/2014, until the end of the study, on 31/12/2019.
measure: Adherence
timeFrame: From inclusion in the study, starting from 01/01/2014, until the end of the study, on 31/12/2019.
measure: Therapeutic inertia
timeFrame: From inclusion in the study, starting from 01/01/2014, until the end of the study, on 31/12/2019.
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: INCLIVA
Study officials:
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