Efficacy and safety of using insulin glargine 300 U/mL in patients on advanced insulin therapy with type 1 or type 2 diabetes failing to achieve their glycemic targets. The Toujeo-Neo trial.
- Conditions
- Type 1 and type 2 diabetes mellitus in adult patients requiring insulin therapy.Nutritional, Metabolic, Endocrine
- Registration Number
- ISRCTN93674355
- Lead Sponsor
- Sanofi-Aventis Deutschland GmbH
- 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:
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 2500
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.
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.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method