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

Completed Last updated 28 September 2022

What this trial tests

trial testing GLP-1RA in Type 2 Diabetes in 26,944 participants. Completed in 1 September 2022.

Timeline

1 January 2014

Primary endpoint
31 December 2019

1 September 2022

Quick facts

Lead sponsor	Ana Palanca
Status	Completed
Study type	OBSERVATIONAL
Enrollment	26,944
Start date	1 January 2014
Primary completion	31 December 2019
Estimated completion	1 September 2022
Sites	1 location across Spain

Drugs / interventions tested

• GLP-1RA — full drug profile →
• SGLT2i — full drug profile →
• Insulin (insulin) — full drug profile →
• Miscellany — full drug profile →

Conditions studied

• Type 2 Diabetes — all drugs for Type 2 Diabetes →
• Obesity — all drugs for Obesity →

Sponsor

Ana Palanca — full company profile →

Who can join

Adults 18 to 125, any sex, with Type 2 Diabetes or Obesity. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Real-World Evaluation of GLP-1 Receptor Agonist Therapy Persistence, Adherence and Therapeutic Inertia Among Obese Adults with Type 2 Diabetes.
   Palanca A, Ampudia-Blasco FJ, Calderón JM, Sauri I, et al · · 2023 · cited 30× · PMID 36847952 · DOI 10.1007/s13300-023-01382-9