Assessment Study of Three Different Fasting Plasma Glucose Targets in Chinese Patients With Type 2 Diabetes Mellitus (BEYOND III/FPG GOAL)
Titration Target for Chinese Type 2 Diabetes Mellitus Patients Using Insulin Glargine to Achieve Glycaemic Goals: An Assessment of Three Different Fasting Plasma Glucose Targets - BEYOND III/FPG GOAL Study
2 other identifiers
interventional
947
1 country
44
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 type-2-diabetes-mellitus
Started Sep 2015
Typical duration for phase_4 type-2-diabetes-mellitus
44 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 7, 2015
CompletedFirst Submitted
Initial submission to the registry
September 8, 2015
CompletedFirst Posted
Study publicly available on registry
September 10, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 20, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
April 20, 2018
CompletedApril 25, 2022
April 1, 2022
2.6 years
September 8, 2015
April 21, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of patients with HbA1c <7% achievement
24 weeks
Secondary Outcomes (12)
Percentage of patients achieving HbA1c <=6.5%
24 weeks
Percentage of patients achieving FPG target with HbA1c <7%
24 weeks
Percentage of patients achieving HbA1c <7% without hypoglycemia
24 weeks
Percentage of patients achieving the FPG target without hypoglycemia
24 weeks
Percentage of patients achieving FPG target
24 weeks
- +7 more secondary outcomes
Study Arms (3)
Group 1
EXPERIMENTALInsulin glargine will be administered once daily at bedtime (preferably between 9:00 PM and 11:00 PM) by subcutaneous injection in the abdomen (preferred route) with FPG target of \<=5.6 mmol/L
Group 2
EXPERIMENTALInsulin glargine will be administered once daily at bedtime (preferably between 9:00 PM and 11:00 PM) by subcutaneous injection in the abdomen (preferred route) with FPG target of \<=6.1 mmol/L
Group 3
EXPERIMENTALInsulin glargine will be administered once daily at bedtime (preferably between 9:00 PM and 11:00 PM) by subcutaneous injection in the abdomen (preferred route) with FPG target of \<=7.0 mmol/L
Interventions
Pharmaceutical form: solution Route of administration: subcutaneous
Eligibility Criteria
You may qualify if:
- to 65 years old.
- Type 2 diabetes patients insufficient controlled by 1-3 oral anti-hyperglycemic drugs (OADs) with stable dose at least 3 months:
- If on 1 OAD, provided with the following doses (including but not limited to):
- α-glucosidase inhibitor: 100mg, three times a day (tid);
- metformin: 1.5-2.0 g/day;
- sulphonylureas: sub-maximum (half dose above) to maximum tolerated dose;
- thiazolidinediones: eg. pioglitazone, 30-40 mg/day.
- Besides the medications listed above, if on 1 OAD, others should be maximum tolerated dose allowed in package insert.
- If on 2-3 OADs, any range of dose is acceptable.
- HbA1c \>7%, and ≤10.5%.
- FPG \>7 mmol/L.
- Body mass index (BMI) ≥20 kg/m\^2, and ≤40 kg/m\^2.
- Diabetes duration ≥1 year.
- Physician decides to and the patient is willing to start basal insulin (BI) treatment.
- Willing to join the study and sign the informed consent.
You may not qualify if:
- Type 1 diabetes patients.
- Patients with acute diabetic complications (including unexplained severe hypoglycemia in the last 6 months).
- Previous treatment with insulin for more than 1 month cumulatively in last 1 year, or treatment with insulin in the last 3 months before the screening.
- Known hypoglycemia unawareness or recurrent hypoglycemia.
- Hypersensitivity to study drug or its excipients.
- Any clinically significant acute major organ or systemic disease, or any other situation judged by the Investigator, that is difficult for the 24 weeks follow-up.
- Pregnancy or breastfeeding women.
- Have any mental disorders, lack self-control or not able to express accurately.
- Involved in another clinical trial simultaneously or within a 1 month before start of trial.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sanofilead
Study Sites (44)
Investigational Site Number 156053
Anshan, China
Investigational Site Number 156001
Beijing, China
Investigational Site Number 156002
Beijing, China
Investigational Site Number 156006
Beijing, China
Investigational Site Number 156013
Changchun, 130033, China
Investigational Site Number 156014
Changchun, 130033, China
Investigational Site Number 156022
Changde, 415000, China
Investigational Site Number 156017
Changsha, China
Investigational Site Number 156034
Changzhou, China
Investigational Site Number 156023
Chenzhou, China
Investigational Site Number 156026
Guangzhou, 510515, China
Investigational Site Number 156029
Haikou, 570102, China
Investigational Site Number 156028
Haikou, China
Investigational Site Number 156040
Haikou, China
Investigational Site Number 156039
Hangzhou, 310013, China
Investigational Site Number 156038
Hangzhou, China
Investigational Site Number 156042
Hangzhou, China
Investigational Site Number 156044
Hangzhou, China
Investigational Site Number 156048
Hefei, China
Investigational Site Number 156050
Hefei, China
Investigational Site Number 156011
Kunming, China
Investigational Site Number 156052
Kunming, China
Investigational Site Number 156016
Lanzhou, China
Investigational Site Number 156041
Lishui, China
Investigational Site Number 156020
Nanchang, 330006, China
Investigational Site Number 156018
Nanchang, China
Investigational Site Number 156019
Nanchang, China
Investigational Site Number 156031
Nanjing, China
Investigational Site Number 156043
Nanjing, China
Investigational Site Number 156049
Nanjing, China
Investigational Site Number 156035
Shanghai, China
Investigational Site Number 156036
Shanghai, China
Investigational Site Number 156047
Shanghai, China
Investigational Site Number 156027
Shantou, China
Investigational Site Number 156015
Shenyang, China
Investigational Site Number 156054
Shijiazhuang, China
Investigational Site Number 156007
Tangshan, 063000, China
Investigational Site Number 156010
Tianjin, 300032, China
Investigational Site Number 156055
Wuhan, 430000, China
Investigational Site Number 156037
Xuzhou, China
Investigational Site Number 156033
Yangzhou, China
Investigational Site Number 156030
Yueyang, China
Investigational Site Number 156032
Zhenjiang, 212001, China
Investigational Site Number 156025
Zhuzhou, 412000, China
Related Publications (4)
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.
PMID: 35430674DERIVEDLi 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.
PMID: 34757600DERIVEDMa 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.
PMID: 32671687DERIVEDYang 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.
PMID: 27669747DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Sciences & Operations
Sanofi
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 8, 2015
First Posted
September 10, 2015
Study Start
September 7, 2015
Primary Completion
April 20, 2018
Study Completion
April 20, 2018
Last Updated
April 25, 2022
Record last verified: 2022-04
Data Sharing
- IPD Sharing
- Will share
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org