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

September 26, 2022 updated by: Ana Palanca

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

26944

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Valencia, Spain, 46010
        • INCLIVA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 125 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
GLP-1RA
All GLP-1RA users: all T2D adults treated with GLP-1RA or initiating a GLP-1RA during the study period
Drug: GLP-1RA
All T2D adults treated with Glucagon-like peptide-1 receptor agonists (GLP-1RA) or initiating a GLP-1RA during the study period
SGLT2i
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
Drug: SGLT2i
SGLT2 inhibitors users with no GLP-1RA prescription: all T2D adults treated with Sodium/glucose cotransporter-2 inhibitors (SGLT2i) or initiating treatment with SGLT2i during the study period and who were not treated with a GLP-1RA
Insulin
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
Drug: Insulin
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
Miscellany
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.
Drug: Miscellany
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 and who were treated with other glucose-lowering agents during the study period

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major acute cardiovascular events
Time Frame: 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.
In this work, this composite includes patients suffering from non-fatal acute myocardial infarction (AMI) and non-fatal stroke, transient ischemic attack (TIA), all-cause death, and, heart failure events occurring during the study period (from inclusion in the study until the event or the end of the study period, whichever came first).
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major acute cardiovascular events without heart failure
Time Frame: 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.
In this work, this composite includes patients suffering from non-fatal acute myocardial infarction (AMI) and non-fatal stroke, transient ischemic attack (TIA) and all-cause death occurring during the study period (from inclusion in the study until the event or the end of the study period, whichever came first).
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.
AMI
Time Frame: 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.
Acute myocardial infarction events occurring during the study follow-up (from inclusion in the study until the event or the end of the study period, whichever came first.
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.
Stroke
Time Frame: 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.
Stroke events occurring during the study follow-up (from inclusion in the study until the event or the end of the study period, whichever came first.
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.
Heart Failure
Time Frame: Through study completion (from inclusion in the study until the event or the end of the study period, whichever came first)
Heart failure hospitalization occurring during the study follow-up (from inclusion in the study until the event or the end of the study period, whichever came first.
Through study completion (from inclusion in the study until the event or the end of the study period, whichever came first)
all-cause death
Time Frame: 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.
Death from all causes occurring during the study follow-up (from inclusion in the study until the event or the end of the study period, whichever came first.
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.
Renal progression
Time Frame: 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.
Sustained 40% reduction in eGFR occurring during the study follow-up (from inclusion in the study until the event or the end of the study period, whichever came first.
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.
atrial fibrillation
Time Frame: 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.
Events of atrial fibrillation episodes occurring during the study follow-up (from inclusion in the study until the event or the end of the study period, whichever came first.
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.
Hypoglycemia
Time Frame: 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.
Severe hypoglycemia requiring hospitalization occurring during the study follow-up (from inclusion in the study until the event or the end of the study period, whichever came first.
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.
Persistence
Time Frame: From inclusion in the study, starting from 01/01/2014, until the end of the study, on 31/12/2019.
Persistence on treatment was defined as the percentage of patients continuing treatment from the start of the study period or since the first prescription during the study period until evidence of discontinuation or the end of the study period.
From inclusion in the study, starting from 01/01/2014, until the end of the study, on 31/12/2019.
Adherence
Time Frame: From inclusion in the study, starting from 01/01/2014, until the end of the study, on 31/12/2019.
Treatment adherence was defined as the proportion of days covered (days in which an individual had access to the medication) from the start of the study period or since the first prescription during the study period until treatment discontinuation
From inclusion in the study, starting from 01/01/2014, until the end of the study, on 31/12/2019.
Therapeutic inertia
Time Frame: From inclusion in the study, starting from 01/01/2014, until the end of the study, on 31/12/2019.
Therapeutic inertia was defined as non-intensification of treatment once started despite HbA1c ≥7.5% during follow-up.
From inclusion in the study, starting from 01/01/2014, until the end of the study, on 31/12/2019.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ana Palanca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2014

Primary Completion (Actual)

December 31, 2019

Study Completion (Actual)

September 1, 2022

Study Registration Dates

First Submitted

March 7, 2022

First Submitted That Met QC Criteria

September 6, 2022

First Posted (Actual)

September 10, 2022

Study Record Updates

Last Update Posted (Actual)

September 28, 2022

Last Update Submitted That Met QC Criteria

September 26, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GLP-1RA in T2D

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Obesity

Clinical Trials on GLP-1RA

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in El Salvador

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe