drugset / Trial / NCT02449603
Comparison of Exenatide vs. Biphasic Insulin Aspart 30 on Glucose Variability in Type 2 Diabetes
Phase 4
Completed
150 enrolled
Xijing Hospital
Air Force Military Medical University, China · collabChang'An Hospital · collabFirst Affiliated Hospital Xi'an Jiaotong University · collabSecond Affiliated Hospital of Xi'an Jiaotong University · collabShaanxi Aerospace Hospital · collabShaanxi Provincial People's Hospital · collabXi'an Central Hospital · collabXi'an Gaoxin Hospital · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a multi-centre, open-label, randomized, parallel trial to compare the effect of Exenatide versus Biphasic insulin Aspart 30 on glucose variability and inflammatory markers in type 2 diabetes mellitus (T2DM) patients inadequately controlled with metformin monotherapy.
Timeline
- Start
- 2015-11
- Primary completion
- 2018-04
- Completion
- 2018-04
Publications
- Wang L, Liu X, Yang W, Lai J, Yu X, Liu J, Gao X, Ming J, Ma K, Xu J, Tian Z, He Q, Ji Q. Comparison of Blood Glucose Variability Between Exenatide and Biphasic Insulin Aspart 30 in Chinese Participants with Type 2 Diabetes Inadequately Controlled with Metformin Monotherapy: A Multicenter, Open-Label, Randomized Trial. Diabetes Ther. 2020 Oct;11(10):2313-2328. doi: 10.1007/s13300-020-00904-z. Epub 2020 Aug 27.
- Xu S, Liu X, Ming J, Ji Q. Comparison of exenatide with biphasic insulin aspart 30 on glucose variability in type 2 diabetes: study protocol for a randomized controlled trial. Trials. 2016 Mar 24;17:160. doi: 10.1186/s13063-016-1258-8.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Exenatide | Peptide | 10 ug | — |
| Comparator | biphasic insulin aspart 30 | Protein / enzyme biologic | 0.2 iu/kg | Subcutaneous |
| Comparator | biphasic insulin aspart 30 | Protein / enzyme biologic | 0.4 iu/kg | Subcutaneous |
| Comparator | biphasic insulin aspart 30 | Protein / enzyme biologic | 10 iu | Subcutaneous |
| Comparator | biphasic insulin aspart 30 | Protein / enzyme biologic | 12 iu | Subcutaneous |