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To compare the diagnostic accuracy and time expenditure of screening models based on glycated hemoglobin (HbA^sub 1c^) level and psychometric measures for mood disorder (MD) among children with type 1 diabetes. With semistructured clinical interviews (Schedule for Affective Disorders and Schizophrenia for Children-Present and Lifetime version, 120 min/patient) as a reference for diagnosing MD, including major depressive disorder (MDD), we tested 163 subjects, aged 8 to 18 years, with type 1 diabetes. We evaluated four screening approaches: 1) Children's Depression Inventory (CDI) at 30 min/pat

  • Autores: R.M. Bergenstal, J. Rosenstock, Richard Arakaki, Melvin J. Prince, Yongming Qu, Vlkram P. Slnha, Daniel C. Howey, Scott J. Jacober
  • Localización: Diabetes care, ISSN-e 0149-5992, Vol. 35, Nº. 11, 2012, págs. 2140-2147
  • Idioma: inglés
  • Texto completo no disponible (Saber más ...)
  • Resumen
    • To evaluate whether LY2605541 results in lower fasting blood glucose (FBG) versus insulin glargine (GL). This 12-week, randomized, open-label, Phase 2 study enrolled patients with type 2 diabetes (hemoglobin A^sub 1c^ [A1C] ? 10.5%), taking metformin and/or sulfonylurea with GL or NPH insulin once daily. Patients converted to morning insulin administration during lead-in were randomized 2:1 from GL (n = 248) or NPH insulin (n = 39) to LY2605541 (n = 195) or GL (n = 95) once daily in the morning. At 12 weeks, FBG (mean ± SE) was similar with LY2605541 and GL (118.2 ± 2.0 mg/dL [6.6 ± 0.1 mmol/L] vs. 116.9 ± 2.7 mg/dL [6.5 ± 0.2 mmol/L], P = 0.433) as was A1C (7.0 ± 0.1 vs. 7.2 ± 0.1%, P = 0.279). Intraday blood glucose variability was reduced with LY2605541 (34.4 vs. 39.1 mg/dL [1.9 vs. 2.2 mmol/L], P = 0.031). LY2605541 patients had weight loss (-0.6 ± 0.2 kg, P = 0.007), whereas GL patients gained weight (0.3 ± 0.2 kg, P = 0.662; treatment difference: -0.8 kg, P = 0.001). The incidence and rate of both total hypoglycemia and nocturnal hypoglycemia were comparable between LY2605541 and GL, although, LY2605541 had a 48% reduction in nocturnal hypoglycemia after adjusting for baseline hypoglycemia (P = 0.021). Adverse events were similar across treatments. Alanine aminotransferase and aspartate aminotransferase remained within normal range but were significantly higher with LY2605541 (P ? 0.001). In patients with type 2 diabetes, LY2605541 and GL had comparable glucose control and total hypoglycemia rates, but LY2605541 showed reduced intraday variability, lower nocturnal hypoglycemia, and weight loss relative to GL. [PUBLICATION ABSTRACT]


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