Long-Term Effectiveness of Liraglutide for Treatment of Type 2 Diabetes in a Real-Life Setting: A 24-Month, Multicenter, Non-interventional, Retrospective Study

Annunziata Lapolla, Cesare Berra, Massimo Boemi, Antonio Carlo Bossi, Riccardo Candido, Graziano Di Cianni, Simona Frontoni, Stefano Genovese, Paola Ponzani, Vincenzo Provenzano, Giuseppina T Russo, Luigi Sciangula, Natalino Simioni, Cristiano Bette, Antonio Nicolucci, NN2211-4118 Study Group

Research output: Contribution to journalArticle

Abstract

INTRODUCTION: The aim of the study was to evaluate whether the reduction in glycated hemoglobin (HbA1c) observed in clinical trials with liraglutide in type 2 diabetes (T2D) could be attained in routine clinical practice.

METHODS: ReaL was a multicenter, non-interventional, observational, retrospective, longitudinal study on the effectiveness of liraglutide, a human glucagon-like peptide-1 analog, in individuals with T2D treated in daily practice in Italy. Between 26 March and 16 November 2015, data were taken from clinical records of patients aged ≥ 18 years with treatment follow-up data of up to 24 months and who received their first prescription of liraglutide in 2011.

RESULTS: A total of 1723 patients were included in the analysis. At baseline, mean age was 58.9 years, duration of diabetes was 9.6 years, and HbA1c was 8.3%. At 12 months, 36.1% of patients were prescribed the maximum 1.8 mg dose; 43.5% [95% confidence interval (CI): 40.9; 46.2] of patients attained the primary outcome of a reduction in HbA1c of ≥ 1% point at 12 months. At 24 months, 40.9% (95% CI 38.1; 43.7) of patients had attained the HbA1c target of ≤ 7%. Additionally, body weight significantly decreased by 3.4 kg (95% CI - 3.6; - 3.1, p < 0.0001).

CONCLUSION: In this observational study conducted in routine clinical practice for up to 2 years, treatment with liraglutide improved HbA1c and reduced body weight in a similar fashion to that observed under randomized clinical trial conditions. The data support the use of liraglutide as an effective treatment for T2D in clinical practice.

FUNDING: Novo Nordisk S.p.A.

TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT02255266.

Original languageEnglish
Pages (from-to)243-253
Number of pages11
JournalAdvances in Therapy
Volume35
Issue number2
DOIs
Publication statusPublished - Feb 2018

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Type 2 Diabetes Mellitus
Retrospective Studies
Confidence Intervals
Body Weight
Glucagon-Like Peptide 1
Glycosylated Hemoglobin A
Italy
Observational Studies
Prescriptions
Longitudinal Studies
Therapeutics
Randomized Controlled Trials
Liraglutide
Clinical Trials

Keywords

  • Journal Article

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Long-Term Effectiveness of Liraglutide for Treatment of Type 2 Diabetes in a Real-Life Setting : A 24-Month, Multicenter, Non-interventional, Retrospective Study. / Lapolla, Annunziata; Berra, Cesare; Boemi, Massimo; Bossi, Antonio Carlo; Candido, Riccardo; Di Cianni, Graziano; Frontoni, Simona; Genovese, Stefano; Ponzani, Paola; Provenzano, Vincenzo; Russo, Giuseppina T; Sciangula, Luigi; Simioni, Natalino; Bette, Cristiano; Nicolucci, Antonio; NN2211-4118 Study Group.

In: Advances in Therapy, Vol. 35, No. 2, 02.2018, p. 243-253.

Research output: Contribution to journalArticle

Lapolla, A, Berra, C, Boemi, M, Bossi, AC, Candido, R, Di Cianni, G, Frontoni, S, Genovese, S, Ponzani, P, Provenzano, V, Russo, GT, Sciangula, L, Simioni, N, Bette, C, Nicolucci, A & NN2211-4118 Study Group 2018, 'Long-Term Effectiveness of Liraglutide for Treatment of Type 2 Diabetes in a Real-Life Setting: A 24-Month, Multicenter, Non-interventional, Retrospective Study', Advances in Therapy, vol. 35, no. 2, pp. 243-253. https://doi.org/10.1007/s12325-017-0652-2
Lapolla, Annunziata ; Berra, Cesare ; Boemi, Massimo ; Bossi, Antonio Carlo ; Candido, Riccardo ; Di Cianni, Graziano ; Frontoni, Simona ; Genovese, Stefano ; Ponzani, Paola ; Provenzano, Vincenzo ; Russo, Giuseppina T ; Sciangula, Luigi ; Simioni, Natalino ; Bette, Cristiano ; Nicolucci, Antonio ; NN2211-4118 Study Group. / Long-Term Effectiveness of Liraglutide for Treatment of Type 2 Diabetes in a Real-Life Setting : A 24-Month, Multicenter, Non-interventional, Retrospective Study. In: Advances in Therapy. 2018 ; Vol. 35, No. 2. pp. 243-253.
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T1 - Long-Term Effectiveness of Liraglutide for Treatment of Type 2 Diabetes in a Real-Life Setting

T2 - A 24-Month, Multicenter, Non-interventional, Retrospective Study

AU - Lapolla, Annunziata

AU - Berra, Cesare

AU - Boemi, Massimo

AU - Bossi, Antonio Carlo

AU - Candido, Riccardo

AU - Di Cianni, Graziano

AU - Frontoni, Simona

AU - Genovese, Stefano

AU - Ponzani, Paola

AU - Provenzano, Vincenzo

AU - Russo, Giuseppina T

AU - Sciangula, Luigi

AU - Simioni, Natalino

AU - Bette, Cristiano

AU - Nicolucci, Antonio

AU - NN2211-4118 Study Group

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N2 - INTRODUCTION: The aim of the study was to evaluate whether the reduction in glycated hemoglobin (HbA1c) observed in clinical trials with liraglutide in type 2 diabetes (T2D) could be attained in routine clinical practice.METHODS: ReaL was a multicenter, non-interventional, observational, retrospective, longitudinal study on the effectiveness of liraglutide, a human glucagon-like peptide-1 analog, in individuals with T2D treated in daily practice in Italy. Between 26 March and 16 November 2015, data were taken from clinical records of patients aged ≥ 18 years with treatment follow-up data of up to 24 months and who received their first prescription of liraglutide in 2011.RESULTS: A total of 1723 patients were included in the analysis. At baseline, mean age was 58.9 years, duration of diabetes was 9.6 years, and HbA1c was 8.3%. At 12 months, 36.1% of patients were prescribed the maximum 1.8 mg dose; 43.5% [95% confidence interval (CI): 40.9; 46.2] of patients attained the primary outcome of a reduction in HbA1c of ≥ 1% point at 12 months. At 24 months, 40.9% (95% CI 38.1; 43.7) of patients had attained the HbA1c target of ≤ 7%. Additionally, body weight significantly decreased by 3.4 kg (95% CI - 3.6; - 3.1, p < 0.0001).CONCLUSION: In this observational study conducted in routine clinical practice for up to 2 years, treatment with liraglutide improved HbA1c and reduced body weight in a similar fashion to that observed under randomized clinical trial conditions. The data support the use of liraglutide as an effective treatment for T2D in clinical practice.FUNDING: Novo Nordisk S.p.A.TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT02255266.

AB - INTRODUCTION: The aim of the study was to evaluate whether the reduction in glycated hemoglobin (HbA1c) observed in clinical trials with liraglutide in type 2 diabetes (T2D) could be attained in routine clinical practice.METHODS: ReaL was a multicenter, non-interventional, observational, retrospective, longitudinal study on the effectiveness of liraglutide, a human glucagon-like peptide-1 analog, in individuals with T2D treated in daily practice in Italy. Between 26 March and 16 November 2015, data were taken from clinical records of patients aged ≥ 18 years with treatment follow-up data of up to 24 months and who received their first prescription of liraglutide in 2011.RESULTS: A total of 1723 patients were included in the analysis. At baseline, mean age was 58.9 years, duration of diabetes was 9.6 years, and HbA1c was 8.3%. At 12 months, 36.1% of patients were prescribed the maximum 1.8 mg dose; 43.5% [95% confidence interval (CI): 40.9; 46.2] of patients attained the primary outcome of a reduction in HbA1c of ≥ 1% point at 12 months. At 24 months, 40.9% (95% CI 38.1; 43.7) of patients had attained the HbA1c target of ≤ 7%. Additionally, body weight significantly decreased by 3.4 kg (95% CI - 3.6; - 3.1, p < 0.0001).CONCLUSION: In this observational study conducted in routine clinical practice for up to 2 years, treatment with liraglutide improved HbA1c and reduced body weight in a similar fashion to that observed under randomized clinical trial conditions. The data support the use of liraglutide as an effective treatment for T2D in clinical practice.FUNDING: Novo Nordisk S.p.A.TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT02255266.

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