drugset / Trial / NCT01513473
A Trial Investigating the Efficacy and Safety of Insulin Degludec in Children and Adolescents With Type 1 Diabetes Mellitus
RandomizedParallel-groupOpen-labelTreatment
Summary
This trial is conducted in Africa, Asia, Europe and the United States of America (USA). The aim of this trial is to investigate the efficacy and safety of insulin degludec in children and adolescents with type 1 diabetes mellitus.
Timeline
- Start
- 2012-01-16
- Primary completion
- 2013-07-30
- Completion
- 2013-07-30
Outcome
Met primary endpoint
paper Non-inferiority of IDeg vs. IDet was confirmed for HbA1c at 26 wk; PMID 25683037 ↗
Publications
- Background Thalange N, Deeb L, Klingensmith G, Franco DR, Bardtrum L, Tutkunkardas D, Danne T. The rate of hyperglycemia and ketosis with insulin degludec-based treatment compared with insulin detemir in pediatric patients with type 1 diabetes: An analysis of data from two randomized trials. Pediatr Diabetes. 2019 May;20(3):314-320. doi: 10.1111/pedi.12821. Epub 2019 Feb 10.
- Results Thalange N, Deeb L, Iotova V, Kawamura T, Klingensmith G, Philotheou A, Silverstein J, Tumini S, Ocampo Francisco AM, Kinduryte O, Danne T. Insulin degludec in combination with bolus insulin aspart is safe and effective in children and adolescents with type 1 diabetes. Pediatr Diabetes. 2015 May;16(3):164-76. doi: 10.1111/pedi.12263. Epub 2015 Feb 12.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | insulin degludec | Protein / enzyme biologic | — | Subcutaneous |
| Subject | insulin detemir | Protein / enzyme biologic | — | Subcutaneous |
| Background | insulin aspart | Protein / enzyme biologic | — | Subcutaneous |