drugset / Trial / NCT02906917
A 38 Week Trial Comparing Effect and Safety of Insulin Degludec/Insulin Aspart vs. Insulin Glargine Plus Insulin Aspart in Subjects With Type 2 Diabetes Treated With Basal Insulin With or Without Oral Antidiabetic Treatment in Need of Treatment Intensification
RandomizedParallel-groupOpen-labelTreatment
Summary
Trial comparing effect and safety of insulin degludec/insulin aspart vs. insulin glargine plus insulin aspart in subjects with type 2 diabetes treated with basal insulin with or without oral antidiabetic treatment in need of treatment intensification.
Timeline
- Start
- 2016-09-20
- Primary completion
- 2017-08-31
- Completion
- 2017-12-24
Publications
- Results Philis-Tsimikas A, Astamirova K, Gupta Y, Haggag A, Roula D, Bak BA, Fita EG, Nielsen AM, Demir T. Similar glycaemic control with less nocturnal hypoglycaemia in a 38-week trial comparing the IDegAsp co-formulation with insulin glargine U100 and insulin aspart in basal insulin-treated subjects with type 2 diabetes mellitus. Diabetes Res Clin Pract. 2019 Jan;147:157-165. doi: 10.1016/j.diabres.2018.10.024. Epub 2018 Nov 16.
- Yang W, Akhtar S, Franek E, Haluzik M, Hirose T, Kalyanam B, Kar S, Wu T, Gogas Yavuz D, Unnikrishnan AG. Postprandial Glucose Excursions in Asian Versus Non-Asian Patients with Type 2 Diabetes: A Post Hoc Analysis of Baseline Data from Phase 3 Randomised Controlled Trials of IDegAsp. Diabetes Ther. 2022 Feb;13(2):311-323. doi: 10.1007/s13300-021-01196-7. Epub 2022 Jan 19.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Insulin degludec/insulin aspart | Unknown | — | Subcutaneous |
| Comparator | insulin aspart | Protein / enzyme biologic | — | Subcutaneous |
| Comparator | insulin glargine | Protein / enzyme biologic | — | Subcutaneous |