Assessment Study of Three Different Fasting Plasma Glucose Targets in Chinese Patients With Type 2 Diabetes Mellitus (BEYOND III/FPG GOAL)
NCT ID: NCT02545842
Last Updated: 2022-04-25
Study Results
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Basic Information
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COMPLETED
PHASE4
947 participants
INTERVENTIONAL
2015-09-07
2018-04-20
Brief Summary
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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).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group 1
Insulin 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
INSULIN GLARGINE
Pharmaceutical form: solution
Route of administration: subcutaneous
Group 2
Insulin 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
INSULIN GLARGINE
Pharmaceutical form: solution
Route of administration: subcutaneous
Group 3
Insulin 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
INSULIN GLARGINE
Pharmaceutical form: solution
Route of administration: subcutaneous
Interventions
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INSULIN GLARGINE
Pharmaceutical form: solution
Route of administration: subcutaneous
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
65 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Sciences & Operations
Role: STUDY_DIRECTOR
Sanofi
Locations
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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, , China
Investigational Site Number 156014
Changchun, , China
Investigational Site Number 156022
Changde, , China
Investigational Site Number 156017
Changsha, , China
Investigational Site Number 156034
Changzhou, , China
Investigational Site Number 156023
Chenzhou, , China
Investigational Site Number 156026
Guangzhou, , China
Investigational Site Number 156029
Haikou, , China
Investigational Site Number 156028
Haikou, , China
Investigational Site Number 156040
Haikou, , China
Investigational Site Number 156039
Hangzhou, , 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, , 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, , China
Investigational Site Number 156010
Tianjin, , China
Investigational Site Number 156055
Wuhan, , China
Investigational Site Number 156037
Xuzhou, , China
Investigational Site Number 156033
Yangzhou, , China
Investigational Site Number 156030
Yueyang, , China
Investigational Site Number 156032
Zhenjiang, , China
Investigational Site Number 156025
Zhuzhou, , China
Countries
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References
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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.
Other Identifiers
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U1111-1172-1058
Identifier Type: OTHER
Identifier Source: secondary_id
LANTUL07190
Identifier Type: -
Identifier Source: org_study_id
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