Trial · Observational
CompletedPhase not statedRegistry dataThis trial does not test a peptide that PepBank tracks.
Spain
1 trial · 1 completed
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
NCT055353221 Jan 2014 to 1 Sept 2022
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Other
GLP-1RA
All GLP-1RA users: all T2D adults treated with GLP-1RA or initiating a GLP-1RA during the study period
Other
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
Other
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
Other
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.
Outcomes the sponsor listed as primary.
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).
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).
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.
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.
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.
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.
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.
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.
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.
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.
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
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.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
No results are posted for this trial.
Completed trials do not always post results.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies that cite this trial.
1 study on this page
Indexing hint: Randomized controlled trial · 2020
Leiter et al. 2020Diabetes, obesity & metabolismcited by 29
PMID 32372454PMC7496251DOI 10.1111/dom.14079PUB-32372454
5 studies on this page
PubMed tag: none · 2020
Pasternak et al. 2020Diabetes carecited by 51
PMID 32295809DOI 10.2337/dc19-2088PUB-32295809
PubMed tag: none · 2019
Divino et al. 2019Diabetes therapy : research, treatment and education of diabetes and related disorderscited by 38
PMID 31028689PMC6531601DOI 10.1007/s13300-019-0615-5PUB-31028689
Indexing hint: Meta-analysis (pooled) · 2019
Kristensen et al. 2019The lancet. Diabetes & endocrinologycited by 1,238
PMID 31422062DOI 10.1016/s2213-8587(19)30249-9PUB-31422062
Indexing hint: Review · 2018
Chatterjee et al. 2018Diabetes, obesity & metabolismcited by 29
PMID 29364585DOI 10.1111/dom.13178PUB-29364585
PubMed tag: none · 2017
Divino et al. 2017Diabetes therapy : research, treatment and education of diabetes and related disorderscited by 32
PMID 28070733PMC5306123DOI 10.1007/s13300-016-0224-5PUB-28070733
References listed at the registry that are not in PepBank. They link to PubMed.
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