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Hypoglycaemia risk with insulin degludec compared with insulin glargine in type 2 and type 1 diabetes: a pre-planned meta-analysis of phase 3 trials.
Ratner, R E; Gough, S C L; Mathieu, C; Del Prato, S; Bode, B; Mersebach, H; Endahl, L; Zinman, B.
Afiliación
  • Ratner RE; Division of Endocrinology, Department of Medicine, Georgetown University School of Medicine, Washington, DC, USA. rratner@diabetes.org
Diabetes Obes Metab ; 15(2): 175-84, 2013 Feb.
Article en En | MEDLINE | ID: mdl-23130654
AIM: Hypoglycaemia and the fear of hypoglycaemia are barriers to achieving normoglycaemia with insulin. Insulin degludec (IDeg) has an ultra-long and stable glucose-lowering effect, with low day-to-day variability. This pre-planned meta-analysis aimed to demonstrate the superiority of IDeg over insulin glargine (IGlar) in terms of fewer hypoglycaemic episodes at equivalent HbA1c in type 2 and type 1 diabetes mellitus (T2DM/T1DM). METHODS: Pooled patient-level data for self-reported hypoglycaemia from all seven (five in T2DM and two in T1DM) randomized, controlled, phase 3a, treat-to-target trials in the IDeg clinical development programme comparing IDeg once-daily (OD) vs. IGlar OD were analysed. RESULTS: Four thousand three hundred and thirty subjects (2899 IDeg OD vs. 1431 IGlar OD) were analysed. Among insulin-naïve T2DM subjects, significantly lower rates of overall confirmed, nocturnal confirmed and severe hypoglycaemic episodes were reported with IDeg vs. IGlar: estimated rate ratio (RR):0.83[0.70;0.98](95%) (CI) , RR:0.64[0.48;0.86](95%) (CI) and RR:0.14[0.03;0.70](95%) (CI) . In the overall T2DM population, significantly lower rates of overall confirmed and nocturnal confirmed episodes were reported with IDeg vs. IGlar [RR:0.83[0.74;0.94](95%) (CI) and RR:0.68[0.57;0.82](95%) (CI) ). In the T1DM population, the rate of nocturnal confirmed episodes was significantly lower with IDeg vs. IGlar during maintenance treatment (RR:0.75[0.60;0.94](95%) (CI) ). Reduction in hypoglycaemia with IDeg vs. IGlar was more pronounced during maintenance treatment in all populations. CONCLUSIONS: The limitations of this study include the open-label design and exclusion of subjects with recurrent severe hypoglycaemia. This meta-analysis confirms that similar improvements in HbA1c can be achieved with fewer hypoglycaemic episodes, particularly nocturnal episodes, with IDeg vs. IGlar across a broad spectrum of patients with diabetes.
Asunto(s)

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Insulina de Acción Prolongada / Diabetes Mellitus Tipo 1 / Diabetes Mellitus Tipo 2 / Hipoglucemiantes Tipo de estudio: Clinical_trials / Etiology_studies / Risk_factors_studies / Systematic_reviews Límite: Female / Humans / Male Idioma: En Revista: Diabetes Obes Metab Asunto de la revista: ENDOCRINOLOGIA / METABOLISMO Año: 2013 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: Insulina de Acción Prolongada / Diabetes Mellitus Tipo 1 / Diabetes Mellitus Tipo 2 / Hipoglucemiantes Tipo de estudio: Clinical_trials / Etiology_studies / Risk_factors_studies / Systematic_reviews Límite: Female / Humans / Male Idioma: En Revista: Diabetes Obes Metab Asunto de la revista: ENDOCRINOLOGIA / METABOLISMO Año: 2013 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Reino Unido