drugset / Trial / NCT02545842
Assessment Study of Three Different Fasting Plasma Glucose Targets in Chinese Patients With Type 2 Diabetes Mellitus (BEYOND III/FPG GOAL)
RandomizedParallel-groupOpen-labelTreatment
Summary
Primary Objective: To identify a best fasting plasma glucose (FPG) target for Chinese type 2 diabetes patients using insulin glargine which can provide the highest control rate of glycated hemoglobin (HbA1c) \< 7%. Secondary Objectives: The control rate of HbA1c ≤6.5% achievement. The control rate of HbA1c \<7.0% in patients achieving their FPG target. The percentage of HbA1c \<7% without hypoglycemia. The percentage of patients achieving the FPG target without hypoglycemia. The percentage of patients achieving the FPG target and post prandial glucose (PPG) target (2-hour post breakfast \<10 mmol/L).
Timeline
- Start
- 2015-09-07
- Primary completion
- 2018-04-20
- Completion
- 2018-04-20
Publications
- Wang X, Wu G, Shen D, Zhang X, Yang W. Unmet Needs of Glycaemic Control and Risk Factors of Residual Hyperglycaemia in a Chinese Population with Type 2 Diabetes Initiating Basal Insulin: A Post Hoc Analysis of the FPG GOAL Study. Adv Ther. 2022 Jun;39(6):2820-2830. doi: 10.1007/s12325-022-02128-y. Epub 2022 Apr 16.
- Li L, Yang T, Xue Y, Ruan P, Du J, Li Y, Zhang X, Cui N, Yang W. Influence of Fasting Plasma Glucose Targets on Glycemic Variability in Chinese Participants With Type 2 Diabetes: A Post Hoc Analysis of the FPG GOAL Trial (BEYOND III). Adv Ther. 2022 Jan;39(1):421-429. doi: 10.1007/s12325-021-01932-2. Epub 2021 Nov 10.
- Ma J, Lei M, Li Y, Zhang X, Cui N, Yang W. Influence of Fasting Glucose Levels on Achieving Glycemic Target in Individuals with Type 2 Diabetes: a Post Hoc Analysis. Adv Ther. 2020 Sep;37(9):3816-3826. doi: 10.1007/s12325-020-01410-1. Epub 2020 Jul 15.
- Yang W, Yang Z, Zhao J, Lu H, Luo T. Assessment of three fasting plasma glucose targets for insulin glargine-based therapy in people with type 2 diabetes mellitus in China: study protocol for a randomized controlled trial. Trials. 2016 Sep 26;17(1):470. doi: 10.1186/s13063-016-1588-6.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | insulin glargine | Protein / enzyme biologic | — | Subcutaneous |