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Efficacy and safety of switching from sitagliptin to liraglutide in subjects with type 2 diabetes (LIRA-SWITCH): a randomized, double-blind, double-dummy, active-controlled 26-week trial.
Bailey, T S; Takács, R; Tinahones, F J; Rao, P V; Tsoukas, G M; Thomsen, A B; Kaltoft, M S; Maislos, M.
Afiliación
  • Bailey TS; AMCR Institute, Escondido, California, USA.
  • Takács R; First Department of Medicine, University of Szeged, Szeged, Hungary.
  • Tinahones FJ; Department of Clinical Endocrinology and Nutrition, IBIMA, Hospital Virgen de la Victoria, CIBERobn, Instituto de Salud Carlos III, University of Málaga, Málaga, Spain.
  • Rao PV; Kumudini Devi Diabetes Research Center, Ramdevrao Hospital, Hyderabad, Telangana, India.
  • Tsoukas GM; Department of Endocrinology and Metabolism, McGill University Health Centre, Montreal, Canada.
  • Thomsen AB; Global Development, Medical and Science, GLP-1 and Obesity, Novo Nordisk A/S, Søborg, Denmark.
  • Kaltoft MS; Global Development, Medical and Science, GLP-1 and Obesity, Novo Nordisk A/S, Søborg, Denmark.
  • Maislos M; Atherosclerosis and Metabolism Unit, Soroka UMC, Ben-Gurion University FOHS, Be'er Sheva, Israel.
Diabetes Obes Metab ; 18(12): 1191-1198, 2016 12.
Article en En | MEDLINE | ID: mdl-27381275
AIMS: To confirm superiority on glycaemic control by switching from sitagliptin to liraglutide 1.8 mg/d versus continued sitagliptin. MATERIALS AND METHODS: A randomized, multicentre, double-blind, double-dummy, active-controlled trial across 86 office- or hospital-based sites in North America, Europe and Asia. Subjects with type 2 diabetes who had inadequate glycaemic control (glycated haemoglobin [HbA1c] 7.5-9.5% on sitagliptin (100 mg/d) and metformin (≥1500 mg daily) for ≥90 days were randomized to either switch to liraglutide (n = 203) or continue sitagliptin (n = 204), both with metformin. The primary endpoint was change in HbA1c from baseline to week 26. Change in body weight was a confirmatory secondary endpoint. RESULTS: Greater reduction in mean HbA1c was achieved with liraglutide than with continued sitagliptin [-1.14% vs. -0.54%; estimated mean treatment difference (ETD): -0.61% (95% CI -0.82 to -0.40; p < 0.0001)], confirming superiority of switching to liraglutide. Body weight was reduced more with liraglutide [-3.31 kg vs. -1.64 kg; ETD: -1.67 kg (95% CI -2.34 to -0.99; p < 0.0001)]. Nausea was more common with liraglutide [44 subjects (21.8%)] than with continued sitagliptin [16 (7.8%)]. Three subjects (1.5%) taking sitagliptin reported a confirmed hypoglycaemic episode. CONCLUSIONS: Subjects insufficiently controlled with sitagliptin who switch to liraglutide can obtain clinically relevant reductions in glycaemia and body weight, without compromising safety. A switch from sitagliptin to liraglutide provides an option for improved management of type 2 diabetes while still allowing patients to remain on dual therapy.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Diabetes Mellitus Tipo 2 / Fosfato de Sitagliptina / Liraglutida / Hipoglucemiantes Tipo de estudio: Clinical_trials Límite: Adult / Aged / Aged80 / Female / Humans / Male / Middle aged País/Región como asunto: America do norte / Asia / Europa Idioma: En Revista: Diabetes Obes Metab Asunto de la revista: ENDOCRINOLOGIA / METABOLISMO Año: 2016 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Reino Unido

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Diabetes Mellitus Tipo 2 / Fosfato de Sitagliptina / Liraglutida / Hipoglucemiantes Tipo de estudio: Clinical_trials Límite: Adult / Aged / Aged80 / Female / Humans / Male / Middle aged País/Región como asunto: America do norte / Asia / Europa Idioma: En Revista: Diabetes Obes Metab Asunto de la revista: ENDOCRINOLOGIA / METABOLISMO Año: 2016 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Reino Unido