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
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Sanofi-Aventis Deutschland GmbH
- Enrollment
- 2500
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
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:
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Not specified