OBJECTIVEThis 24-week trial assessed the efficacy and safety of saxagliptin as add-on therapy in patients with type 2 diabetes with inadequate glycemic control with metformin alone.RESEARCH DESIGN AND METHODSThis was a randomized, double-blind, placebo-controlled study of saxagliptin (2.5, 5, or 10 mg once daily) or placebo plus a stable dose of metformin (1,500–2,500 mg) in 743 patients (A1C ≥7.0 and ≤10.0%). Efficacy analyses were performed using an ANCOVA model using last observation carried forward methodology on primary (A1C) and secondary (fasting plasma glucose [FPG] and postprandial glucose [PPG] area under the curve [AUC]) end points.RESULTSSaxagliptin (2.5, 5, and 10 mg) plus metformin demonstrated statistically significant adjusted mean decreases from baseline to week 24 versus placebo in A1C (−0.59, −0.69, and −0.58 vs. +0.13%; all P < 0.0001), FPG (−14.31, −22.03, and −20.50 vs. +1.24 mg/dl; all P < 0.0001), and PPG AUC (−8,891, −9,586, and −8,137 vs. −3,291 mg · min/dl; all P < 0.0001). More than twice as many patients achieved A1C <7.0% with 2.5, 5, and 10 mg saxagliptin versus placebo (37, 44, and 44 vs. 17%; all P < 0.0001). β-Cell function and postprandial C-peptide, insulin, and glucagon AUCs improved in all saxagliptin treatment groups at week 24. Incidence of hypoglycemic adverse events and weight reductions were similar to those with placebo.CONCLUSIONSSaxagliptin once daily added to metformin therapy was generally well tolerated and led to statistically significant improvements in glycemic indexes versus placebo added to metformin in patients with type 2 diabetes inadequately controlled with metformin alone.

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Saxagliptin monotherapy or add-on to metformin is generally safe and well tolerated, with no increased risk of hypoglycaemia, for up to 4 years.

resumo: Objetivou-se avaliar duas intervenções educativas para a prevenção do Diabetes Mellitus tipo 2 em adolescentes de risco. Participaram 90 alunos de uma escola pública de Fortaleza, Ceará, Brasil, divididos em dois grupos: GA (n=45) e GB (n=45). O GA recebeu intervenção educativa individual, mediante um folder, e o GB, intervenção educativa grupal, abrangendo cinco encontros de duas horas cada um. Utilizaram-se questionários para avaliar o nível de conhecimento antes, um dia após e decorridos 60 dias das intervenções, e as mudanças de hábitos cotidianos, 60 dias após as intervenções. Os resultados evidenciaram que, para o nível de conhecimento, ambas as intervenções desenvolvidas não apresentaram diferença (p=0,0001). Ao comparar os grupos A e B, após as intervenções, observou-se que a intenção para mudança dos hábitos cotidianos foi semelhante. As duas intervenções educativas podem ser utilizadas nas escolas para a prevenção do Diabetes Mellitus tipo 2 em adolescentes de risco.descritores: Educação em saúde. Diabetes mellitus. Saúde do adolescente. evAluAtinG two educAtionAl interventions to prevent type 2 diabetes mellitus AmonG AdolescentsABstrAct: This study aimed to evaluate two educational interventions to prevent type 2 Diabetes Mellitus among at-risk adolescents. Participants were 90 students from a public school in the city of Fortaleza, Ceará, Brazil, divided into two groups: GA (n=45), and GB (n=45). In the GA group, a flyer was used to individually explain the educational group interventions, while the GB group received educational intervention through five meetings of two hours each. Questionnaires were used to evaluate the level of knowledge before, the day after, and 60 days after interventions as well as changes in daily habits, 60 days after interventions. Results showed no difference between both interventions (p=0.0001) considering the level of knowledge. A similar intention to change daily habits was observed upon comparing groups A and B after the interventions. The two educational interventions can be used in schools in order to prevent type 2 Diabetes Mellitus in at-risk adolescents.descriptors: Health education. Diabetes mellitus. Adolescent health.evAluAción de dos intervenciones educAtivAs pArA lA prevención de lA diabetes mellitus tipo 2 en Adolescentes resumen: El estudio tuvo como objetivo evaluar dos intervenciones educativas para la prevención de la Diabetes Mellitus tipo 2 en adolescentes en riesgo. Participaron del estudio noventa estudiantes de una escuela pública en la ciudad de Fortaleza, Ceará, Brasil, divididos en dos grupos: GA (n=45) y GB (n=45). El grupo GA recibió una intervención educativa individual, por medio de un folleto, y el grupo GB, una intervención educativa en grupo que comprendió cinco sesiones de dos horas cada una. Se utilizaron cuestionarios para evaluar el nivel de conocimientos antes, al día siguiente, y 60 días después de las intervenciones; y los cambios en los hábitos diarios 60 días después del uso de las intervenciones. Los resultados mostraro...