Clinical trial NCT02545842: Assessment Study of Three Different Fasting Plasma Glucose Targets in Chinese Patients With Type 2 Diabetes Mellitus (BEYOND III/FPG GOAL)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2015-09-10
Enrollment: 947
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Detailed description: The study duration for each patient will be 27 weeks.

Eligibility criteria: Inclusion criteria :

* 18 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.

Exclusion criteria:

* 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.

Primary outcomes:
measure: Percentage of patients with HbA1c <7% achievement
timeFrame: 24 weeks
Secondary outcomes:
measure: Percentage of patients achieving HbA1c <=6.5%
timeFrame: 24 weeks
measure: Percentage of patients achieving FPG target with HbA1c <7%
timeFrame: 24 weeks
measure: Percentage of patients achieving HbA1c <7% without hypoglycemia
timeFrame: 24 weeks
measure: Percentage of patients achieving the FPG target without hypoglycemia
timeFrame: 24 weeks
measure: Percentage of patients achieving FPG target
timeFrame: 24 weeks
measure: Percentage of patients achieving PPG target (2-hour post-breakfast <10 mmol/L)
timeFrame: 24 weeks
measure: Change from baseline in HbA1c
timeFrame: Baseline to 24 weeks
measure: Change in FPG
timeFrame: 8 weeks to 24 weeks
measure: Change in PPG
timeFrame: Baseline to 24 weeks
measure: Change in insulin doses in each arm
timeFrame: 1 week to 24 weeks
measure: Change in body weight in each treatment arm
timeFrame: Baseline to 24 weeks
measure: Percentage of patients experienced hypoglycemic events
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Anshan
country: China
facility: Investigational Site Number 156053
city: Beijing
country: China
facility: Investigational Site Number 156001
city: Beijing
country: China
facility: Investigational Site Number 156002
city: Beijing
country: China
facility: Investigational Site Number 156006
city: Changchun
country: China
facility: Investigational Site Number 156013
city: Changchun
country: China
facility: Investigational Site Number 156014
city: Changde
country: China
facility: Investigational Site Number 156022
city: Changsha
country: China
facility: Investigational Site Number 156017
city: Changzhou
country: China
facility: Investigational Site Number 156034
city: Chenzhou
country: China
facility: Investigational Site Number 156023
city: Guangzhou
country: China
facility: Investigational Site Number 156026
city: Haikou
country: China
facility: Investigational Site Number 156029
city: Haikou
country: China
facility: Investigational Site Number 156028
city: Haikou
country: China
facility: Investigational Site Number 156040
city: Hangzhou
country: China
facility: Investigational Site Number 156039
city: Hangzhou
country: China
facility: Investigational Site Number 156038
city: Hangzhou
country: China
facility: Investigational Site Number 156042
city: Hangzhou
country: China
facility: Investigational Site Number 156044
city: Hefei
country: China
facility: Investigational Site Number 156048
city: Hefei
country: China
facility: Investigational Site Number 156050
city: Kunming
country: China
facility: Investigational Site Number 156011
city: Kunming
country: China
facility: Investigational Site Number 156052
city: Lanzhou
country: China
facility: Investigational Site Number 156016
city: Lishui
country: China
facility: Investigational Site Number 156041
city: Nanchang
country: China
facility: Investigational Site Number 156020
city: Nanchang
country: China
facility: Investigational Site Number 156018
city: Nanchang
country: China
facility: Investigational Site Number 156019
city: Nanjing
country: China
facility: Investigational Site Number 156031
city: Nanjing
country: China
facility: Investigational Site Number 156043
city: Nanjing
country: China
facility: Investigational Site Number 156049
city: Shanghai
country: China
facility: Investigational Site Number 156035
city: Shanghai
country: China
facility: Investigational Site Number 156036
city: Shanghai
country: China
facility: Investigational Site Number 156047
city: Shantou
country: China
facility: Investigational Site Number 156027
city: Shenyang
country: China
facility: Investigational Site Number 156015
city: Shijiazhuang
country: China
facility: Investigational Site Number 156054
city: Tangshan
country: China
facility: Investigational Site Number 156007
city: Tianjin
country: China
facility: Investigational Site Number 156010
city: Wuhan
country: China
facility: Investigational Site Number 156055
city: Xuzhou
country: China
facility: Investigational Site Number 156037
city: Yangzhou
country: China
facility: Investigational Site Number 156033
city: Yueyang
country: China
facility: Investigational Site Number 156030
city: Zhenjiang
country: China
facility: Investigational Site Number 156032
city: Zhuzhou
country: China
facility: Investigational Site Number 156025
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.