drugset / Trial / NCT04664764
Intermediate and Long Acting Insulin Young Children Type 1 Diabetes.
RandomizedParallel-groupOpen-labelTreatment
Summary
Background: Achieving glycemic control without risking hypoglycemia imposes a major challenge in the management of toddlers and preschool children with Type 1 diabetes(T1D). Optimal insulin therapy for young children with T1D should provide effective glycemic control while minimizing the risk of hypoglycemia and hyperglycemia. Despite the advantages of the basal-bolus insulin regimens, hypoglycemia still presents a major barrier in achieving desirable glycemic control. Objectives: To compare the effectiveness of insulin degludec to insulin glargine and NPH in toddlers and preschool children with T1D in terms of glycosylated hemoglobin(HbA1C) and frequency of hypoglycemic episodes.
Timeline
- Start
- 2019-02-21
- Primary completion
- 2021-02-28
- Completion
- 2021-03-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Degludec | Protein / enzyme biologic | — | — |
| Comparator | Insulin | Protein / enzyme biologic | — | — |
| Comparator | insulin glargine | Protein / enzyme biologic | — | — |