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

Yang, Wenying; Yang, Zhaojun; Zhao, Jing; Lu, Hai; Luo, Tianhong

doi:10.1186/s13063-016-1588-6

Cited by 4 publications

(5 citation statements)

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“…This was a 24 week, open‐label, parallel‐group, randomized, treat‐to‐target study (http://clinicaltrials.gov identifier: NCT02545842). The study design and methods have been reported previously . Briefly, eligible patients were between 18 and 65 years of age, had a diagnosis of T2D, with HbA1c >7% to ≤10.5% despite stable doses of one to three oral anti‐hyperglycaemic drugs (OADs) for at least 3 months, had fasting plasma glucose (FPG) of >7 mmol/L, had a body mass index of ≥20 to ≤40 kg/m 2 , had a duration of diabetes of at least 1 year, and were willing to initiate treatment with basal insulin.…”

Section: Methodsmentioning

confidence: 99%

“…However, the proportion of patients who achieved HbA1c <7% without hypoglycaemia (glucose ≤3.1 mmol/L) was the same in the two target groups . The present study was designed to evaluate the effect of three pre‐defined FBG targets on the proportion of Chinese patients with T2D who achieved HbA1c <7.0% . The FBG targets to which patients were randomized were 3.9 < FBG ≤7.0, 3.9 < FBG ≤6.1 and 3.9 < FBG ≤5.6 mmol/L.…”

Section: Introductionmentioning

confidence: 99%

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Determining the optimal fasting glucose target for patients with type 2 diabetes: Results of the multicentre, open‐label, randomized‐controlled FPG GOAL trial

Yang

Yuan

et al. 2019

Diabetes Obesity Metabolism

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The optimal fasting blood glucose (FBG) target of achieving HbA1c less than 7.0% in type 2 diabetes (T2D) patients remains controversial. This open‐label trial randomized (1:3:3) 947 adults with uncontrolled T2D (HbA1c >7% to ≤10.5%) who were using one to three oral antidiabetic drugs to achieve an FBG target of 3.9 < FBG ≤5.6 mmol/L (Group 1), 3.9 < FBG ≤6.1 mmol/L (Group 2) or of 3.9 < FBG ≤7.0 mmol/L (Group 3). Targets were achieved using a pre‐defined insulin glargine 100 U/mL titration scheme. The primary endpoint was proportion of patients achieving HbA1c <7.0% at 24 weeks. At 24 weeks, 44.4%, 46.1% and 37.7% of patients achieved HbA1c <7.0% in Groups 1, 2 and 3, respectively (P = 0.017; Group 2 vs Group 3). Alert hypoglycaemia (glucose ≤3.9 mmol/L) was significantly more frequent in Group 1 than in Group 3 (38.9 vs 23.3%; P < 0.001) but was not in Group 2 vs Group 3 (27.5% vs 23.3%; P = 0.177). Clinically important hypoglycaemia (glucose ≤3.0 mmol/L) was reported in 4.8%, 2.0% and 3.8% of patients in Groups 1, 2 and 3, respectively. In conclusion, the optimal FBG target for most Chinese patients with T2D appears to be 3.9‐6.1 mmol/L.

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Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Determining the optimal fasting glucose target for patients with type 2 diabetes: Results of the multicentre, open‐label, randomized‐controlled FPG GOAL trial

Yang

Yuan

et al. 2019

Diabetes Obesity Metabolism

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“…The study design and methods for the FPG GOAL study (ClinicalTrials.gov identifier NCT02545842) have been reported previously [ 23 , 24 ]. Briefly, FPG GOAL enrolled individuals with T2D and an HbA1c > 53 mmol/mol (> 7.0%) to ≤ 91 mmol/mol (≤ 10.5%) and FPG > 7 mmol/L despite receiving stable doses of 1–3 OADs for at least 3 months.…”

Section: Methodsmentioning

confidence: 99%

“…The primary endpoint of FPG GOAL study was the proportion of participants achieving an HbA1c < 53 mmol/mol (< 7%) at 24 weeks [ 23 , 24 ]. Secondary endpoints included the change from baseline in HbA1c, FPG, PPG and PPG excursions, body weight and BMI at 24 weeks.…”

Section: Methodsmentioning

confidence: 99%

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

Wang

Shen

et al. 2022

Adv Ther

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Introduction To aim of this analysis was to investigate the extent and evaluate risk factors of residual hyperglycaemia in Chinese individuals with type 2 diabetes (T2D) initiating basal insulin. Methods FPG GOAL was a 24-week, open-label, treat-to-target randomised controlled trial in Chinese individuals with T2D inadequately controlled with oral anti-hyperglycaemic drugs initiating treatment with basal insulin. This analysis categorised participants into the following glycaemic control categories: hyperglycaemia [glycated haemoglobin (HbA1c) ≥ 53 mmol/mol (≥ 7%), fasting plasma glucose (FPG) ≥ 7.0 mmol/L], residual hyperglycaemia [HbA1c ≥ 53 mmol/mol (≥ 7%), FPG < 7.0 mmol/L], discordant [HbA1c < 53 mmol/mol (< 7%), FPG ≥ 7.0 mmol/L] and at target [HbA1c < 53 mmol/mol (< 7%), FPG < 7.0 mmol/L]. The proportion of participants in each glycaemic control category was assessed at weeks 12 and 24. Multivariable regression analyses were conducted to evaluate risk factors for residual hyperglycaemia. Results Of the 914 participants included, 22.1% had residual hyperglycaemia, 31.9% had hyperglycaemia, 11.1% were discordant and 29.3% were at target at week 24. More participants who were randomised to a fasting blood glucose (FBG) target of > 3.9 to ≤ 5.6 mmol/L had residual hyperglycaemia compared with participants randomised to a FBG target of > 3.9 to ≤ 6.1 mmol/L or > 3.9 to ≤ 7.0 mmol/L. Multivariable analysis indicated that higher HbA1c and lower FPG levels at baseline were associated with greater proportion of residual hyperglycaemia. Conclusion Some Chinese individuals with T2D may have residual hyperglycaemia 3–6 months after initiating basal insulin treatment and require further intensified treatment. Higher HbA1c and lower FPG levels could be risk factors for residual hyperglycaemia. Trial Registration ClinicalTrials.gov identifier NCT02545842. Supplementary Information The online version contains supplementary material available at 10.1007/s12325-022-02128-y.

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“…The study design and methods for the FPG GOAL study (ClinicalTrials.gov identifier NCT02545842) have been reported previously [8,9]. Briefly, FPG GOAL included individuals aged 18-65 years with T2D, with HbA1c levels between [ 7% and B 10.5%, were inadequately controlled with stable doses of 1-3 oral antidiabetic drugs (OADs) for C 3 months, had fasting plasma glucose (FPG) of [ 7 mmol/L, a body mass index of C 20 to B 40 kg/m 2 , with duration of diabetes of at least 1 year and those who were willing to start treatment with basal insulin.…”

Section: Study Design and Participantsmentioning

confidence: 99%

Influence of Fasting Glucose Levels on Achieving Glycemic Target in Individuals with Type 2 Diabetes: a Post Hoc Analysis

Ma¹,

Lei

et al. 2020

Adv Ther

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Introduction: FPG GOAL was a 24-week, openlabel, treat-to-target randomized controlled trial which demonstrated that the optimal selfmonitored fasting blood glucose (SM-FBG) target for most Chinese individuals with type 2 diabetes (T2D) using insulin glargine 100 IU/mL was 3.9-6.1 mmol/L. Individuals who achieved lower fasting plasma glucose (FPG) levels might achieve the target HbA1c of \ 7% without increasing the risk of hypoglycemia. Methods: For this post hoc analysis, individuals were redivided into three groups based on their actual laboratory FPG levels at 24 weeks: level 1, B 5.6 mmol/L; level 2, [ 5.6 to B 6.1 mmol/L; and level 3, [ 6.1 to B 7.0 mmol/L. Results: At week 24, 863 individuals with diabetes had available FPG data and 179, 122, and 179 individuals achieved FPG levels 1, 2, and 3, respectively. The proportion of individuals with HbA1c \ 7% or HbA1c \ 7% without hypoglycemia (B 3.9 or B 3.0 mmol/L) was significantly higher in FPG levels 1 (p \ 0.01) and 2 (p \ 0.05) than in level 3. The least squares mean changes from baseline in HbA1c (-1.77% and -1.66% vs -1.34%; both p \ 0.001) and 2-h postprandial glucose (-3.88 mmol/L and -3.98 mmol/L vs -3.22 mmol/L; both p \ 0.05) were also significantly higher in FPG levels 1 and 2 compared with level 3. Linear regression analysis showed a moderate relationship between FPG and HbA1c levels at 24 weeks (r = 0.449). Conclusions: Chinese individuals with T2D who achieved lower FPG levels with insulin glargine 100 IU/mL were more likely to achieve the recommended target HbA1c of \ 7% compared with those with higher FPG levels. Clini-calTrials.gov identifier NCT02545842.

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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

Cited by 4 publications

References 24 publications

Determining the optimal fasting glucose target for patients with type 2 diabetes: Results of the multicentre, open‐label, randomized‐controlled FPG GOAL trial

Determining the optimal fasting glucose target for patients with type 2 diabetes: Results of the multicentre, open‐label, randomized‐controlled FPG GOAL trial

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

Influence of Fasting Glucose Levels on Achieving Glycemic Target in Individuals with Type 2 Diabetes: a Post Hoc Analysis

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