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

Ana Palanca

Status: Completed

Conditions: Obesity; Type 2 Diabetes

Treatments: Drug: SGLT2i; Drug: Insulin; Drug: Miscellany; Drug: GLP-1RA

Study type: Observational

Funder types: Other

Identifiers

NCT05535322

GLP-1RA in T2D

Details and patient eligibility

About

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.

Enrollment: 26,944 patients

Sex: All

Ages: 18 to 125 years old

Volunteers: No Healthy Volunteers

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

Trial design

26,944 participants in 4 patient groups

GLP-1RA

Description:

All GLP-1RA users: all T2D adults treated with GLP-1RA or initiating a GLP-1RA during the study period

Treatment:

Drug: GLP-1RA

SGLT2i

Description:

SGLT2 inhibitors users with no GLP-1RA prescription: all T2D adults treated with SGLT2i or initiating treatment with SGLT2i during the study period and who were not treated with a GLP-1RA

Treatment:

Drug: SGLT2i

Insulin

Description:

Insulin users with no GLP-1RA and/or SGLT2i prescriptions: all T2D adults treated with insulin or initiating insulin treatment during the study period and who were not treated with GLP-1RA/SGLT2i

Treatment:

Drug: Insulin

Miscellany

Description:

Other glucose-lowering agents users: all T2D adults who were not treated with GLP-1RA and/or SGLT2i and/or insulin during the study period.

Treatment:

Drug: Miscellany