Assessment of Treatment Efficacy and Safety when switching the Basal component of any BOTplus or Basal-Bolus Regimen in Patients Failing to Reach Treatment Targets to Insulin glargine U300
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 2,500
研究概览
简要总结
2016 Poster results in https://doi.org/10.1055/s-0036-1580967 Pscherer S, Pfohl M, Anderten H, Pegelow K, Seufert J. Nicht-interventionelle Studie zur Untersuchung der Effizienz des Wechsels der Basalinsulinkomponente bei einer BOTplus oder intensivierten Insulintherapie (ICT) zu Insulin glargin 0 E/ml bei Typ-1- und Typ-2-Diabetespatienten mit inadäquater glykämischer Kontrolle. Diabetologie & Stoffwechsel 2016; 11 (Suppl. 1): Abstr. P220. Presented as poster at the 51rst Annual Meeting of the German Diabetes Association (DDG) at 05.05.2016 in Berlin, Germany. Available at: 2018 Poster results in https://doi.org/10.1055/s-0038-1641939 Fritsche A, Pscherer S, Pfohl M, Anderten H, Pegelow K, Seufert J. Umstellung des Basalinsulins auf Insulin glargin 0 E/ml (Gla-0) nach Versagen der Basis-Bolus-Therapie (ICT) mit einem anderen Basalinsulin verbesserte bei Typ-1-Diabetespatienten die Blutzucker-Einstellung – 6-Monats-Ergebnisse der Toujeo-Neo-T1DM-Studie. Diabetologie & Stoffwechsel 2018; 13 (Suppl. 1): S61, Abstract P181. Presented as poster at the 53rst Annual Meeting of the German Diabetes Association (DDG) at 11.05.2018 in Berlin, Germany. Available at: 2018 Poster results in https://doi.org/10.1055/s-0038-1641911 Pscherer S, Pfohl M, Fritsche A, Anderten H, Pegelow K, Seufert J. Umstellung des Basalinsulins auf Insulin glargin 0 E/ml (Gla-0) nach Versagen einer Basis-Bolus- (ICT) oder einer basalunterstützten oralen Therapie mit einmal täglich prandialem Insulin (BOTplus) mit einem anderen Basalinsulin verbesserte bei Typ-2-Diabetespatienten die glykämische Kontrolle – 6-Monats-Ergebnisse der Toujeo-Neo-T2DM-Studie. Diabetologie & Stoffwechsel 2018; 13 (Suppl. 1): S51-S52, Abstract P153. Presented as poster at the 53rst Annual Meeting of the German Diabetes Association (DDG) at 11.05.2018 in Berlin, Germany. Available at: 2018 Abstract results in https://doi.org/10.2337/db18-2288-PUB Pscherer S, Fritsche A, Anderten H, Pegelow K, Seufert J, Pfohl M. Switching to Insulin Glargine 0 U/mL (Gla-0) after Failure of Advanced Insulin Therapy (IT) with Other Basal Insulins (BI) in Patients (Pts) with Type 2 Diabetes (T2DM) Improved Glycemic Control. Diabetes 2018; 67 (Suppl. 1): Abstract 2288-PUB (Published only). Available at: 2018 Poster results in https://doi.org/10.2337/db18-1031-P Fritsche A, Pscherer S, Anderten H, Pegelow K, Seufert J, Pfohl M. Switching to Insulin Glargine 0 U/mL (Gla-0) Improves Glycemic Control After Failure of Basal-Bolus Therapy (BBT) With Other Basal Insulins (BI) in patients (pts) with Type 1 Diabetes (T1DM). Diabetes 2018; 67 (Suppl. 1): Abstract 1031-P. Presented as poster at the 78th Scientific Sessions of the American Diabetes Association at 23.06.2018 in Orlando, FL, USA. Available at:
研究设计
- 研究类型
- Observational
入排标准
- 性别
- All
入选标准
- •1. Patients with type 1 diabetes (basal-bolus insulin therapy) or type 2 diabetes (basal insulin plus 1-2x prandial insulin and oral antidiabetic drugs or basal-bolus insulin therapy) with any basal insulin except insulin glargine 300 U/mL.
- •2. Adults and Seniors: Age at least 18 years, no upper age limit.
- •3. HbA1c between 7.5% to 10.0%.
- •4. Fasting blood glucose > 130 mg/dL.
- •5. Ability and willingness to perform blood glucose self-monitoring.
排除标准
- •1. Contraindications for a therapy with insulin glargine 300 U/mL.
- •2. Patients receiving oral antidiabetic drug therapy only.
- •3. Patients receiving basal insulin and oral antidiabetic drugs without prandial insulin.
- •4. Patients with known cancer disease.
- •5. Pregnancy.
- •6. Drug or alcohol abuse.
- •7. Dementia or general incapacity to understand the content of the observational study.