RESUMO
BACKGROUND: Type 2 diabetes is a growing problem in Mexico. The present study was undertaken to evaluate the efficacy and safety of rosiglitazone 2 mg or 4 mg twice daily (bd) in combination with metformin 2.5 g/day in Mexican patients whose type 2 diabetes was inadequately controlled with metformin alone. METHODS: This randomized, double-blind, placebo-controlled study was conducted at four centers in Mexico. A total of 116 patients were randomized to metformin 2.5 g/day plus placebo (n=39), metformin 2.5 g/day plus rosiglitazone 2 mg bd (n=37), or metformin 2.5 g/day plus rosiglitazone 4 mg bd (n=40) for 26 weeks. RESULTS: Mean hemoglobin A(1c) (HbA(1c)) levels decreased significantly from baseline to Week 26 in the rosiglitazone 2 mg bd (-0.7%; p=0.0052) and 4 mg bd (-1.2%; p=0.0008) groups, but increased in the placebo group (+0.3%; p=0.2651). Mean fasting plasma glucose and fructosamine levels also improved significantly with metformin plus rosiglitazone therapy in a dose-ordered manner compared with placebo (pAssuntos
Diabetes Mellitus Tipo 2/tratamento farmacológico
, Metformina/uso terapêutico
, Tiazóis/uso terapêutico
, Tiazolidinedionas
, Adulto
, Idoso
, Glicemia/metabolismo
, Diabetes Mellitus Tipo 2/sangue
, Relação Dose-Resposta a Droga
, Método Duplo-Cego
, Quimioterapia Combinada
, Etnicidade
, Ácidos Graxos não Esterificados/sangue
, Feminino
, Hemoglobinas Glicadas/metabolismo
, Humanos
, Lipoproteínas HDL/sangue
, Lipoproteínas LDL/sangue
, Masculino
, Metformina/efeitos adversos
, México
, Pessoa de Meia-Idade
, Placebos
, Rosiglitazona
, Segurança
, Tiazóis/efeitos adversos
, Triglicerídeos/sangue