Improved glycemic and weight control with Dulaglutide addition in SGLT2 inhibitor treated obese type 2 diabetic patients at high cardiovascular risk in a real-world setting. The AWARE−2 study

We evaluated the effects on glycemic control and body weight of a GLP1-RA in obese type 2 diabetic patients treated with SGLT2-inhibitors and other hypoglycemic agents and/or insulin, in a real-world setting. A cohort of 583 type 2 diabetic outpatients treated with a SGLT2 inhibitor and/or other ant...

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Main Authors: Cesare Berra, Roberto Manfrini, Francesco Bifari, Elisa Cipponeri, Renata Ghelardi, Lucia Centofanti, Umberto Mortola, Elena Lunati, Loredana Bucciarelli, Vincenzo Cimino, Franco Folli
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Language:English
Published: Elsevier 2024-12-01
Series:Pharmacological Research
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Online Access:http://www.sciencedirect.com/science/article/pii/S1043661824004626
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author Cesare Berra
Roberto Manfrini
Francesco Bifari
Elisa Cipponeri
Renata Ghelardi
Lucia Centofanti
Umberto Mortola
Elena Lunati
Loredana Bucciarelli
Vincenzo Cimino
Franco Folli
author_facet Cesare Berra
Roberto Manfrini
Francesco Bifari
Elisa Cipponeri
Renata Ghelardi
Lucia Centofanti
Umberto Mortola
Elena Lunati
Loredana Bucciarelli
Vincenzo Cimino
Franco Folli
author_sort Cesare Berra
collection DOAJ
description We evaluated the effects on glycemic control and body weight of a GLP1-RA in obese type 2 diabetic patients treated with SGLT2-inhibitors and other hypoglycemic agents and/or insulin, in a real-world setting. A cohort of 583 type 2 diabetic outpatients treated with a SGLT2 inhibitor and/or other anti-diabetic medications were examined. Because patients had suboptimal glycemic control, the GLP1-RA Dulaglutide was added to ongoing medications. At 6 months, 334 patients had a follow-up visit. Patients were classified in terms of cardiovascular risk (CVR) employing the ESC-EASD 2019 criteria, with the AWARE app. The study’s primary endpoints were changes in: 1) HbA1c level, 2) BMI, and 3) body weight after six months of treatment. Secondary endpoints were evaluation of Dulaglutide addition in type 2 diabetic patients: 1) with more or less than ten years of T2DM; 2) more or less than 75 years of age and in different subgroups of CVR. In the 334 patients which had a 6 months follow-up visit, age was 65,9+9,8; 33.5 % (112) were females and 66.5 % (222) were males. After six months of Dulaglutide treatment, we found a significant reduction in HbA1c levels (8.0+10.5 mmol/mol; p<0.0001) and in body mass index (1.1+1.1 kg/m2; p<0.0001). Efficacy of Dulaglutide was not affected by different CVD risk categories, age and T2DM duration. This real world study provides evidence for significant reductions in HbA1c level, body mass index and body weight in obese type 2 diabetic patients who received add-on treatment with the weekly GLP-1RA, Dulaglutide.
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spelling doaj-art-809d86e79ffb45e6b4dd60d82ba3bd1d2024-12-18T08:47:22ZengElsevierPharmacological Research1096-11862024-12-01210107517Improved glycemic and weight control with Dulaglutide addition in SGLT2 inhibitor treated obese type 2 diabetic patients at high cardiovascular risk in a real-world setting. The AWARE−2 studyCesare Berra0Roberto Manfrini1Francesco Bifari2Elisa Cipponeri3Renata Ghelardi4Lucia Centofanti5Umberto Mortola6Elena Lunati7Loredana Bucciarelli8Vincenzo Cimino9Franco Folli10Department of Endocrinology and Metabolic Diseases, IRCCS Multimedica, Milan, Italy; Corresponding author.Department of Endocrinology and Metabolic Diseases, IRCCS Multimedica, Milan, Italy; Departmental Unit of Diabetes and Metabolism, San Paolo Hospital, ASST Santi Paolo e Carlo, Milan, Italy; Endocrinology and Metabolism, Department of Health Science, Università degli Studi di Milano, Milan, ItalyLaboratory of Cell Metabolism and Regenerative Medicine, Department of Medical Biotechnology and Translational Medicine, University of Milan, LITA, Segrate, ItalyDepartment of Endocrinology and Metabolic Diseases, IRCCS Multimedica, Milan, Italy; Department of Biomedical Sciences for Health, University of Milan, Milan, ItalyUOC Coordinamento e Integrazione Rete ASST Melegnano e della MartesanaEndocrinology and Metabolism, Department of Health Science, Università degli Studi di Milano, Milan, ItalyEndocrinology and Metabolism, Department of Health Science, Università degli Studi di Milano, Milan, ItalyDivision of Endocrinology, ASST Fatebenefratelli-Sacco, Milan, ItalyInternational Center for T1D, Pediatric Clinical Research Center Romeo ed Enrica Invernizzi, DIBIC, Università di Milano, Milan, ItalyDepartment of Biomedical and Clinical Sciences L. Sacco Endocrinology and Diabetology, Milan, ItalyDepartmental Unit of Diabetes and Metabolism, San Paolo Hospital, ASST Santi Paolo e Carlo, Milan, Italy; Endocrinology and Metabolism, Department of Health Science, Università degli Studi di Milano, Milan, Italy; Corresponding author at: Departmental Unit of Diabetes and Metabolism, San Paolo Hospital, ASST Santi Paolo e Carlo, Milan, Italy.We evaluated the effects on glycemic control and body weight of a GLP1-RA in obese type 2 diabetic patients treated with SGLT2-inhibitors and other hypoglycemic agents and/or insulin, in a real-world setting. A cohort of 583 type 2 diabetic outpatients treated with a SGLT2 inhibitor and/or other anti-diabetic medications were examined. Because patients had suboptimal glycemic control, the GLP1-RA Dulaglutide was added to ongoing medications. At 6 months, 334 patients had a follow-up visit. Patients were classified in terms of cardiovascular risk (CVR) employing the ESC-EASD 2019 criteria, with the AWARE app. The study’s primary endpoints were changes in: 1) HbA1c level, 2) BMI, and 3) body weight after six months of treatment. Secondary endpoints were evaluation of Dulaglutide addition in type 2 diabetic patients: 1) with more or less than ten years of T2DM; 2) more or less than 75 years of age and in different subgroups of CVR. In the 334 patients which had a 6 months follow-up visit, age was 65,9+9,8; 33.5 % (112) were females and 66.5 % (222) were males. After six months of Dulaglutide treatment, we found a significant reduction in HbA1c levels (8.0+10.5 mmol/mol; p<0.0001) and in body mass index (1.1+1.1 kg/m2; p<0.0001). Efficacy of Dulaglutide was not affected by different CVD risk categories, age and T2DM duration. This real world study provides evidence for significant reductions in HbA1c level, body mass index and body weight in obese type 2 diabetic patients who received add-on treatment with the weekly GLP-1RA, Dulaglutide.http://www.sciencedirect.com/science/article/pii/S1043661824004626Type 2 Diabetes MellitusCardiovascular riskAWARE appGlucagon Like Peptide 1 Receptor AgonistsSodium-Glucose Co-Transporter-2 inhibitors
spellingShingle Cesare Berra
Roberto Manfrini
Francesco Bifari
Elisa Cipponeri
Renata Ghelardi
Lucia Centofanti
Umberto Mortola
Elena Lunati
Loredana Bucciarelli
Vincenzo Cimino
Franco Folli
Improved glycemic and weight control with Dulaglutide addition in SGLT2 inhibitor treated obese type 2 diabetic patients at high cardiovascular risk in a real-world setting. The AWARE−2 study
Pharmacological Research
Type 2 Diabetes Mellitus
Cardiovascular risk
AWARE app
Glucagon Like Peptide 1 Receptor Agonists
Sodium-Glucose Co-Transporter-2 inhibitors
title Improved glycemic and weight control with Dulaglutide addition in SGLT2 inhibitor treated obese type 2 diabetic patients at high cardiovascular risk in a real-world setting. The AWARE−2 study
title_full Improved glycemic and weight control with Dulaglutide addition in SGLT2 inhibitor treated obese type 2 diabetic patients at high cardiovascular risk in a real-world setting. The AWARE−2 study
title_fullStr Improved glycemic and weight control with Dulaglutide addition in SGLT2 inhibitor treated obese type 2 diabetic patients at high cardiovascular risk in a real-world setting. The AWARE−2 study
title_full_unstemmed Improved glycemic and weight control with Dulaglutide addition in SGLT2 inhibitor treated obese type 2 diabetic patients at high cardiovascular risk in a real-world setting. The AWARE−2 study
title_short Improved glycemic and weight control with Dulaglutide addition in SGLT2 inhibitor treated obese type 2 diabetic patients at high cardiovascular risk in a real-world setting. The AWARE−2 study
title_sort improved glycemic and weight control with dulaglutide addition in sglt2 inhibitor treated obese type 2 diabetic patients at high cardiovascular risk in a real world setting the aware 2 study
topic Type 2 Diabetes Mellitus
Cardiovascular risk
AWARE app
Glucagon Like Peptide 1 Receptor Agonists
Sodium-Glucose Co-Transporter-2 inhibitors
url http://www.sciencedirect.com/science/article/pii/S1043661824004626
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