IDegLira for the Real-World Treatment of Type 2 Diabetes in Italy: Protocol and Interim Results from the REX Observational Study

Gian Paolo Fadini; Raffaella Buzzetti; Maria Rosa Fittipaldi; Ferruccio D’Incau; Andrea Da Porto; Angela Girelli; Lucia Simoni; Giusi Lastoria; Agostino Consoli; Nicolangelo Iazzetta; Giuseppe Di Giovanni; Ornella Carbonara; Concetta Aragiusto; Diego Carleo; Nicoletta Da Rosa; Emilia Martedì; Luigi Landolfi; Marta Marracino; Anna Tortora; Annalisa Tortora; Gianluca De Morelli; Viviana Casarsa; Ernesto Maddaloni; Antonio Siena; Annunziata Siena; Dario Pitocco; Linda Tartaglione; Alessandro Rizzi; Frida Leonetti; Martina Fasolo; Gabriele Morsello; Rocco Bulzomì; Gilda Ruga; Andrea Bianconi; Enrico Torre; Enza Torre; Alberto Rebora; Francesca Cecoli; Eleonora Monti; Silvia Bonfadini; Silvia Dotti; Sara Madaschi; Roberto Trevisan; Mascia Albizzi; Rosalia Bellante; Anna Corsi; Alessandro Corsi; Cristina Scaranna; Pasquale De Cata; Federico Liboà; Stefania Ghilotti; Elena Tortato; Luigi Lanari; Federica Turchi; Enrico Gabellieri; Olga Lamacchia; Cinzia Colucci; Giovanni Mileti; Sara Coluzzi; Simone Coluzzi; Federica Carrieri; Paola Rossetti; Massimiliano Anzaldi; Mauro Anzaldi; Antonino Di Benedetto; Domenica Ruggeri; Alessia Scatena; Anna Ranchelli; Ivana Ragusa; Giovanna Gregori; Isabella Crisci; Mary Mori; Marco Ernesto Mori; Fabio Baccetti; Roberto Anichini; Elisabetta Salutini; Carmela Vinci; Isabella Colletti; Milena Sira Zanon; Anna Altomari; Benedetta Maria Bonora

doi:10.1007/s13300-022-01287-z

IDegLira for the Real-World Treatment of Type 2 Diabetes in Italy: Protocol and Interim Results from the REX Observational Study

Gian Paolo Fadini, Raffaella Buzzetti, Maria Rosa Fittipaldi, Ferruccio D’Incau, Andrea Da Porto, Angela Girelli, Lucia Simoni, Giusi Lastoria, Agostino Consoli, Nicolangelo Iazzetta, Giuseppe Di Giovanni, Ornella Carbonara, Concetta Aragiusto, Diego Carleo, Nicoletta Da Rosa, Emilia Martedì, Luigi Landolfi, Marta Marracino, Anna Tortora, Annalisa TortoraGianluca De Morelli, Viviana Casarsa, Ernesto Maddaloni, Antonio Siena, Annunziata Siena, Dario Pitocco, Linda Tartaglione, Alessandro Rizzi, Frida Leonetti, Martina Fasolo, Gabriele Morsello, Rocco Bulzomì, Gilda Ruga, Andrea Bianconi, Enrico Torre, Enza Torre, Alberto Rebora, Francesca Cecoli, Eleonora Monti, Silvia Bonfadini, Silvia Dotti, Sara Madaschi, Roberto Trevisan, Mascia Albizzi, Rosalia Bellante, Anna Corsi, Alessandro Corsi, Cristina Scaranna, Pasquale De Cata, Federico Liboà, Stefania Ghilotti, Elena Tortato, Luigi Lanari, Federica Turchi, Enrico Gabellieri, Olga Lamacchia, Cinzia Colucci, Giovanni Mileti, Sara Coluzzi, Simone Coluzzi, Federica Carrieri, Paola Rossetti, Massimiliano Anzaldi, Mauro Anzaldi, Antonino Di Benedetto, Domenica Ruggeri, Alessia Scatena, Anna Ranchelli, Ivana Ragusa, Giovanna Gregori, Isabella Crisci, Mary Mori, Marco Ernesto Mori, Fabio Baccetti, Roberto Anichini, Elisabetta Salutini, Carmela Vinci, Isabella Colletti, Milena Sira Zanon, Anna Altomari, Benedetta Maria Bonora

Risultato della ricerca: Contributo in rivista › Articolo in rivista

Abstract

Introduction: IDegLira was shown to maintain glycemic control while reducing risk of hypoglycemia and body weight gain. The REX study was designed to generate real-world evidence on the use of IDegLira in Italian clinical practice in two different subgroups of patients, those switching to IDegLira from a basal insulin-supported oral therapy (BOT group) and those from a basal plus bolus insulin regimen (BB group). Methods: Adult patients with T2D diagnosed for at least 12 months and having started IDegLira 2–3 months prior to enrolment, coming from a BOT or BB regimen, were enrolled in this multicenter observational prospective cohort study conducted in 28 Italian centers. This paper presents the methodological framework of the REX study and provides the interim analysis results describing the patients’ baseline characteristics and the clinical reasons for IDegLira treatment initiation. Results: Of the 360 patients enrolled in the REX study, 331 were considered eligible for this interim analysis, 76.4% in the BOT and 23.6% in the BB group. Mean (SD) HbA1c was 8.5% (1.4) in the BOT and 8.2% (1.7) in the BB group. The most common T2D complications were diabetic macroangiopathy and diabetic nephropathy in both groups. The median (interquartile range) insulin daily dose before IDegLira was 15.0 (10.0–20.0) units in the BOT group and 42 (30.0–52.0) in the BB group. Oral antidiabetics were taken by 98% and 51.3% of patients, respectively. The main reason for switching to IDegLira was the inadequate glycemic control in the BOT group (86% of patients), and the intent to simplify the treatment in the BB group (66.7%). Conclusions: IdegLira is initiated after BOT in inadequately controlled patients to improve glycemic control, whereas in BB patients it is used to simplify the therapeutic regimen. Final results of the REX study will shed light on patients’ outcomes after IdegLira treatment under routine clinical care.

Lingua originale	English
pagine (da-a)	1483-1497
Numero di pagine	15
Rivista	Diabetes Therapy
Volume	2022
DOI	https://doi.org/10.1007/s13300-022-01287-z
Stato di pubblicazione	Pubblicato - 2022

Keywords

Basal bolus therapy (BB)
Basal insulin analogue
Basal oral therapy (BOT)
Glycated hemoglobin (HbA1c)
IDegLira
Oral antidiabetic drugs (OADs)
Rapid insulin analogue
Real-world evidence
Type 2 diabetes

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Fadini, G. P., Buzzetti, R., Fittipaldi, M. R., D’Incau, F., Da Porto, A., Girelli, A., Simoni, L., Lastoria, G., Consoli, A., Iazzetta, N., Di Giovanni, G., Carbonara, O., Aragiusto, C., Carleo, D., Da Rosa, N., Martedì, E., Landolfi, L., Marracino, M., Tortora, A., ... Bonora, B. M. (2022). IDegLira for the Real-World Treatment of Type 2 Diabetes in Italy: Protocol and Interim Results from the REX Observational Study. Diabetes Therapy, 2022, 1483-1497. https://doi.org/10.1007/s13300-022-01287-z

@article{b1a0c99f891b4fc4bf2130971b002c86,

title = "IDegLira for the Real-World Treatment of Type 2 Diabetes in Italy: Protocol and Interim Results from the REX Observational Study",

abstract = "Introduction: IDegLira was shown to maintain glycemic control while reducing risk of hypoglycemia and body weight gain. The REX study was designed to generate real-world evidence on the use of IDegLira in Italian clinical practice in two different subgroups of patients, those switching to IDegLira from a basal insulin-supported oral therapy (BOT group) and those from a basal plus bolus insulin regimen (BB group). Methods: Adult patients with T2D diagnosed for at least 12 months and having started IDegLira 2–3 months prior to enrolment, coming from a BOT or BB regimen, were enrolled in this multicenter observational prospective cohort study conducted in 28 Italian centers. This paper presents the methodological framework of the REX study and provides the interim analysis results describing the patients{\textquoteright} baseline characteristics and the clinical reasons for IDegLira treatment initiation. Results: Of the 360 patients enrolled in the REX study, 331 were considered eligible for this interim analysis, 76.4% in the BOT and 23.6% in the BB group. Mean (SD) HbA1c was 8.5% (1.4) in the BOT and 8.2% (1.7) in the BB group. The most common T2D complications were diabetic macroangiopathy and diabetic nephropathy in both groups. The median (interquartile range) insulin daily dose before IDegLira was 15.0 (10.0–20.0) units in the BOT group and 42 (30.0–52.0) in the BB group. Oral antidiabetics were taken by 98% and 51.3% of patients, respectively. The main reason for switching to IDegLira was the inadequate glycemic control in the BOT group (86% of patients), and the intent to simplify the treatment in the BB group (66.7%). Conclusions: IdegLira is initiated after BOT in inadequately controlled patients to improve glycemic control, whereas in BB patients it is used to simplify the therapeutic regimen. Final results of the REX study will shed light on patients{\textquoteright} outcomes after IdegLira treatment under routine clinical care.",

keywords = "Basal bolus therapy (BB), Basal insulin analogue, Basal oral therapy (BOT), Glycated hemoglobin (HbA1c), IDegLira, Oral antidiabetic drugs (OADs), Rapid insulin analogue, Real-world evidence, Type 2 diabetes, Basal bolus therapy (BB), Basal insulin analogue, Basal oral therapy (BOT), Glycated hemoglobin (HbA1c), IDegLira, Oral antidiabetic drugs (OADs), Rapid insulin analogue, Real-world evidence, Type 2 diabetes",

author = "Fadini, {Gian Paolo} and Raffaella Buzzetti and Fittipaldi, {Maria Rosa} and Ferruccio D{\textquoteright}Incau and {Da Porto}, Andrea and Angela Girelli and Lucia Simoni and Giusi Lastoria and Agostino Consoli and Nicolangelo Iazzetta and {Di Giovanni}, Giuseppe and Ornella Carbonara and Concetta Aragiusto and Diego Carleo and {Da Rosa}, Nicoletta and Emilia Marted{\`i} and Luigi Landolfi and Marta Marracino and Anna Tortora and Annalisa Tortora and {De Morelli}, Gianluca and Viviana Casarsa and Ernesto Maddaloni and Antonio Siena and Annunziata Siena and Dario Pitocco and Linda Tartaglione and Alessandro Rizzi and Frida Leonetti and Martina Fasolo and Gabriele Morsello and Rocco Bulzom{\`i} and Gilda Ruga and Andrea Bianconi and Enrico Torre and Enza Torre and Alberto Rebora and Francesca Cecoli and Eleonora Monti and Silvia Bonfadini and Silvia Dotti and Sara Madaschi and Roberto Trevisan and Mascia Albizzi and Rosalia Bellante and Anna Corsi and Alessandro Corsi and Cristina Scaranna and {De Cata}, Pasquale and Federico Libo{\`a} and Stefania Ghilotti and Elena Tortato and Luigi Lanari and Federica Turchi and Enrico Gabellieri and Olga Lamacchia and Cinzia Colucci and Giovanni Mileti and Sara Coluzzi and Simone Coluzzi and Federica Carrieri and Paola Rossetti and Massimiliano Anzaldi and Mauro Anzaldi and {Di Benedetto}, Antonino and Domenica Ruggeri and Alessia Scatena and Anna Ranchelli and Ivana Ragusa and Giovanna Gregori and Isabella Crisci and Mary Mori and Mori, {Marco Ernesto} and Fabio Baccetti and Roberto Anichini and Elisabetta Salutini and Carmela Vinci and Isabella Colletti and Zanon, {Milena Sira} and Anna Altomari and Bonora, {Benedetta Maria}",

year = "2022",

doi = "10.1007/s13300-022-01287-z",

language = "English",

volume = "2022",

pages = "1483--1497",

journal = "Diabetes Therapy",

issn = "1869-6961",

publisher = "Springer Publishing Company",

}

Fadini, GP, Buzzetti, R, Fittipaldi, MR, D’Incau, F, Da Porto, A, Girelli, A, Simoni, L, Lastoria, G, Consoli, A, Iazzetta, N, Di Giovanni, G, Carbonara, O, Aragiusto, C, Carleo, D, Da Rosa, N, Martedì, E, Landolfi, L, Marracino, M, Tortora, A, Tortora, A, De Morelli, G, Casarsa, V, Maddaloni, E, Siena, A, Siena, A, Pitocco, D, Tartaglione, L, Rizzi, A, Leonetti, F, Fasolo, M, Morsello, G, Bulzomì, R, Ruga, G, Bianconi, A, Torre, E, Torre, E, Rebora, A, Cecoli, F, Monti, E, Bonfadini, S, Dotti, S, Madaschi, S, Trevisan, R, Albizzi, M, Bellante, R, Corsi, A, Corsi, A, Scaranna, C, De Cata, P, Liboà, F, Ghilotti, S, Tortato, E, Lanari, L, Turchi, F, Gabellieri, E, Lamacchia, O, Colucci, C, Mileti, G, Coluzzi, S, Coluzzi, S, Carrieri, F, Rossetti, P, Anzaldi, M, Anzaldi, M, Di Benedetto, A, Ruggeri, D, Scatena, A, Ranchelli, A, Ragusa, I, Gregori, G, Crisci, I, Mori, M, Mori, ME, Baccetti, F, Anichini, R, Salutini, E, Vinci, C, Colletti, I, Zanon, MS, Altomari, A & Bonora, BM 2022, 'IDegLira for the Real-World Treatment of Type 2 Diabetes in Italy: Protocol and Interim Results from the REX Observational Study', Diabetes Therapy, vol. 2022, pagg. 1483-1497. https://doi.org/10.1007/s13300-022-01287-z

TY - JOUR

T1 - IDegLira for the Real-World Treatment of Type 2 Diabetes in Italy: Protocol and Interim Results from the REX Observational Study

AU - Fadini, Gian Paolo

AU - Buzzetti, Raffaella

AU - Fittipaldi, Maria Rosa

AU - D’Incau, Ferruccio

AU - Da Porto, Andrea

AU - Girelli, Angela

AU - Simoni, Lucia

AU - Lastoria, Giusi

AU - Consoli, Agostino

AU - Iazzetta, Nicolangelo

AU - Di Giovanni, Giuseppe

AU - Carbonara, Ornella

AU - Aragiusto, Concetta

AU - Carleo, Diego

AU - Da Rosa, Nicoletta

AU - Martedì, Emilia

AU - Landolfi, Luigi

AU - Marracino, Marta

AU - Tortora, Anna

AU - Tortora, Annalisa

AU - De Morelli, Gianluca

AU - Casarsa, Viviana

AU - Maddaloni, Ernesto

AU - Siena, Antonio

AU - Siena, Annunziata

AU - Pitocco, Dario

AU - Tartaglione, Linda

AU - Rizzi, Alessandro

AU - Leonetti, Frida

AU - Fasolo, Martina

AU - Morsello, Gabriele

AU - Bulzomì, Rocco

AU - Ruga, Gilda

AU - Bianconi, Andrea

AU - Torre, Enrico

AU - Torre, Enza

AU - Rebora, Alberto

AU - Cecoli, Francesca

AU - Monti, Eleonora

AU - Bonfadini, Silvia

AU - Dotti, Silvia

AU - Madaschi, Sara

AU - Trevisan, Roberto

AU - Albizzi, Mascia

AU - Bellante, Rosalia

AU - Corsi, Anna

AU - Corsi, Alessandro

AU - Scaranna, Cristina

AU - De Cata, Pasquale

AU - Liboà, Federico

AU - Ghilotti, Stefania

AU - Tortato, Elena

AU - Lanari, Luigi

AU - Turchi, Federica

AU - Gabellieri, Enrico

AU - Lamacchia, Olga

AU - Colucci, Cinzia

AU - Mileti, Giovanni

AU - Coluzzi, Sara

AU - Coluzzi, Simone

AU - Carrieri, Federica

AU - Rossetti, Paola

AU - Anzaldi, Massimiliano

AU - Anzaldi, Mauro

AU - Di Benedetto, Antonino

AU - Ruggeri, Domenica

AU - Scatena, Alessia

AU - Ranchelli, Anna

AU - Ragusa, Ivana

AU - Gregori, Giovanna

AU - Crisci, Isabella

AU - Mori, Mary

AU - Mori, Marco Ernesto

AU - Baccetti, Fabio

AU - Anichini, Roberto

AU - Salutini, Elisabetta

AU - Vinci, Carmela

AU - Colletti, Isabella

AU - Zanon, Milena Sira

AU - Altomari, Anna

AU - Bonora, Benedetta Maria

PY - 2022

Y1 - 2022

N2 - Introduction: IDegLira was shown to maintain glycemic control while reducing risk of hypoglycemia and body weight gain. The REX study was designed to generate real-world evidence on the use of IDegLira in Italian clinical practice in two different subgroups of patients, those switching to IDegLira from a basal insulin-supported oral therapy (BOT group) and those from a basal plus bolus insulin regimen (BB group). Methods: Adult patients with T2D diagnosed for at least 12 months and having started IDegLira 2–3 months prior to enrolment, coming from a BOT or BB regimen, were enrolled in this multicenter observational prospective cohort study conducted in 28 Italian centers. This paper presents the methodological framework of the REX study and provides the interim analysis results describing the patients’ baseline characteristics and the clinical reasons for IDegLira treatment initiation. Results: Of the 360 patients enrolled in the REX study, 331 were considered eligible for this interim analysis, 76.4% in the BOT and 23.6% in the BB group. Mean (SD) HbA1c was 8.5% (1.4) in the BOT and 8.2% (1.7) in the BB group. The most common T2D complications were diabetic macroangiopathy and diabetic nephropathy in both groups. The median (interquartile range) insulin daily dose before IDegLira was 15.0 (10.0–20.0) units in the BOT group and 42 (30.0–52.0) in the BB group. Oral antidiabetics were taken by 98% and 51.3% of patients, respectively. The main reason for switching to IDegLira was the inadequate glycemic control in the BOT group (86% of patients), and the intent to simplify the treatment in the BB group (66.7%). Conclusions: IdegLira is initiated after BOT in inadequately controlled patients to improve glycemic control, whereas in BB patients it is used to simplify the therapeutic regimen. Final results of the REX study will shed light on patients’ outcomes after IdegLira treatment under routine clinical care.

AB - Introduction: IDegLira was shown to maintain glycemic control while reducing risk of hypoglycemia and body weight gain. The REX study was designed to generate real-world evidence on the use of IDegLira in Italian clinical practice in two different subgroups of patients, those switching to IDegLira from a basal insulin-supported oral therapy (BOT group) and those from a basal plus bolus insulin regimen (BB group). Methods: Adult patients with T2D diagnosed for at least 12 months and having started IDegLira 2–3 months prior to enrolment, coming from a BOT or BB regimen, were enrolled in this multicenter observational prospective cohort study conducted in 28 Italian centers. This paper presents the methodological framework of the REX study and provides the interim analysis results describing the patients’ baseline characteristics and the clinical reasons for IDegLira treatment initiation. Results: Of the 360 patients enrolled in the REX study, 331 were considered eligible for this interim analysis, 76.4% in the BOT and 23.6% in the BB group. Mean (SD) HbA1c was 8.5% (1.4) in the BOT and 8.2% (1.7) in the BB group. The most common T2D complications were diabetic macroangiopathy and diabetic nephropathy in both groups. The median (interquartile range) insulin daily dose before IDegLira was 15.0 (10.0–20.0) units in the BOT group and 42 (30.0–52.0) in the BB group. Oral antidiabetics were taken by 98% and 51.3% of patients, respectively. The main reason for switching to IDegLira was the inadequate glycemic control in the BOT group (86% of patients), and the intent to simplify the treatment in the BB group (66.7%). Conclusions: IdegLira is initiated after BOT in inadequately controlled patients to improve glycemic control, whereas in BB patients it is used to simplify the therapeutic regimen. Final results of the REX study will shed light on patients’ outcomes after IdegLira treatment under routine clinical care.

KW - Basal bolus therapy (BB)

KW - Basal insulin analogue

KW - Basal oral therapy (BOT)

KW - Glycated hemoglobin (HbA1c)

KW - IDegLira

KW - Oral antidiabetic drugs (OADs)

KW - Rapid insulin analogue

KW - Real-world evidence

KW - Type 2 diabetes

KW - Basal bolus therapy (BB)

KW - Basal insulin analogue

KW - Basal oral therapy (BOT)

KW - Glycated hemoglobin (HbA1c)

KW - IDegLira

KW - Oral antidiabetic drugs (OADs)

KW - Rapid insulin analogue

KW - Real-world evidence

KW - Type 2 diabetes

UR - http://hdl.handle.net/10807/228328

U2 - 10.1007/s13300-022-01287-z

DO - 10.1007/s13300-022-01287-z

M3 - Article

SN - 1869-6961

VL - 2022

SP - 1483

EP - 1497

JO - Diabetes Therapy

JF - Diabetes Therapy

ER -

IDegLira for the Real-World Treatment of Type 2 Diabetes in Italy: Protocol and Interim Results from the REX Observational Study

Abstract

Keywords

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