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

Abstract

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.

Fasting Glucose of 6.1 mmol/L as a Possible Optimal Target for Type 2 Diabetic Patients with Insulin Glargine: A Randomized Clinical Trial

“…Similarly, in our study, we observed that T2D patients receiving insulin glargine had a significant reduction in HbA1c value after the 24-week treatment period, with HbA1c values varying from 6:8 ± 0:7 to 7:3 ± 0:8% at the endpoint. Interestingly, in accordance with our outcome regarding the benefits of GV improvement in patients with an FBG of 6.1 mmol/L as the titration target, we also found that patients in Group 2 had a significant HbA1c value reduction as compared to those in Groups 1 and 3, which was in agreement with a previous study reporting that using an FBG of 6.1 mmol/L as the insulin glargine titration target led to significant HbA1c value improvements in T2D patients [27].…”

“…In this study, not all patients achieved the preset FBG goals as assigned, with the ratio between the three groups being similar at 24 weeks. Specifically, the ratio in the BEYOND III was 70.1%, 67.6%, and 79.0% in Groups 1, 2, and 3, respectively [27]. Although most previous studies have employed HbA1c as the primary glycaemic control measure [28], this only provides an approximate measurement of glucose control, since it does not address acute/short-term GV or hypoglycaemic events [29].…”

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

“…Individuals with T2D were randomized (1:3:3) to an SM-FBG target of [ 3.9 to B 5.6 mmol/L (group 1), [ 3.9 to B 6.1 mmol/L (group 2), or [ 3.9 to B 7.0 mmol/L (group 3) using a predefined insulin glargine 100 IU/mL titration algorithm [8]. Subcutaneous once-daily administration of insulin glargine 100 IU/mL was initiated at a dose of 0.2 U/kg and titrated over the 24-week treatment period.…”

“…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.…”

“…FPG GOAL was the first 24-week open-label, treat-to-target randomized controlled trial in Chinese individuals with T2D to demonstrate that a self-monitored fasting blood glucose (SM-FBG) target range of 3.9-6.1 mmol/L may be optimal to achieve the desired target HbA1c of \ 7% with insulin glargine 100 IU/mL while minimizing the risk of hypoglycemia [8]. The aim of this post hoc analysis was to determine the glycemic end points of individuals with T2D enrolled in FPG GOAL on the basis of their 24-week laboratory-determined FPG levels, specifically among individuals with T2D who met the FPG target in their original randomized group, and individuals with T2D who were regrouped by their actual FPG levels at 24 weeks.…”