Efficacy and safety of imeglimin in patients with type 2 diabetes mellitus: A systematic review and meta-analysis of randomized clinical trials

Abdelhaleem, Ibrahim Abdelmonaem; Salamah, Hazem Mohamed; Alsabbagh, Feras Ammar; Eid, Ahmed Mohammed; Hussien, Hadeer Mohamed; Mohamed, Nada Ismail; Ebada, Mahmoud Ahmed

doi:10.1016/j.dsx.2021.102323

Cited by 21 publications

(9 citation statements)

References 19 publications

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“…In contrast, both GLP1RAs and SGLT2 inhibitors have provided cardiovascular benefits in large‐scale RCTs, leading to a paradigm shift beyond glucose control to a broader strategy of comprehensive cardiovascular risk reduction in type 2 diabetes mellitus. Recently, imeglimin and dual glucose‐dependent insulinotropic peptide (GIP)/GLP‐1RA, tirzepatide, have been developed 149 , 150 , 151 . Imeglimin improves mitochondrial function, which may result in cardiovascular event reduction 152 .…”

Section: Discussionmentioning

confidence: 99%

Treatment of diabetes mellitus has borne much fruit in the prevention of cardiovascular disease

Yagyu

Shimano

2022

J of Diabetes Invest

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Cardiovascular (CV) disease is the most alarming complication of diabetes mellitus (DM), and a strategy aiming at cardiovascular event prevention in diabetes mellitus has long been debated. Large landmark clinical trials have shown cardiovascular benefits of intensive glycemic control as a ‘legacy effect’ in newly diagnosed type 2 diabetes mellitus. In contrast, we have learned that excessive intervention aimed at strong glycemic control could cause unexpected cardiovascular death in patients who are resistant to treatments against hyperglycemia. It has also been shown that the comprehensive multifactorial intervention for cardiovascular risk factors that was advocated in the current guideline provided substantial cardiovascular event reduction. The impact of classical antidiabetic agents launched before 1990s on cardiovascular events is controversial. Although there are many clinical or observational studies assessing the impact of those agents on cardiovascular events, the conclusions are inconsistent owing to variable patient backgrounds and concomitant antidiabetic agents among the studies. Moreover, most of them were not large‐scale, randomized, cardiovascular outcome trials. In contrast, GLP‐1RA (glucagon‐like peptide‐1 receptor agonist) and SGLT2 (sodium‐glucose cotransporter 2) inhibitors have demonstrated undeniable cardiovascular benefits in large‐scale, randomized, controlled trials. Whereas GLP‐1RAs decrease atherosclerotic disease, especially stroke, SGLT2 inhibitors mainly prevent heart failure. SGLT2 inhibitors are superior to GLP‐1RAs with respect to hard renal outcomes. Therefore, it can be said that drugs such as GLP‐1RAs and SGLT2 inhibitors that prevent cardiovascular events, in addition to their glucose‐lowering effect, are incredible novel tools that we have gained for use in diabetic treatment.

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Section: Discussionmentioning

confidence: 99%

Treatment of diabetes mellitus has borne much fruit in the prevention of cardiovascular disease

Yagyu

Shimano

2022

J of Diabetes Invest

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“…Diabetes mellitus (DM) is one of the major public health challenges worldwide that burdens global public health [ 1 , 2 ]. The disease prevalence has increased considerably in both developed and developing countries over the past decades [ 3 – 5 ].…”

Section: Introductionmentioning

confidence: 99%

Level of Agreement and Correlation Between the Estimated Hemoglobin A1c Results Derived by Continuous or Conventional Glucose Monitoring Systems Compared with the Point-of-Care or Laboratory-Based Measurements: An Observational Study

et al. 2022

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Introduction Hemoglobin A1C (HbA1c) is an important marker for diabetes care management. With the increasing use of new technologies such as continuous glucose monitoring (CGM) and point-of-care testing (POCT), patients and their physicians have been able to monitor and continuously check their blood glucose levels in an efficient and timely manner. This study aimed to investigate the level of agreement between the standard laboratory test for HbA1c (Lab-HbA1c) with point-of-care testing (POCT-HbA1c) and glucose monitoring index (GMI) derived by intermittently scanned CGM (isCGM) or estimated average glucose (eAG) derived by conventional self-monitored blood glucose (SMBG) devices. Methods A cross-sectional study was conducted at the Diabetes Treatment Center, Prince Sultan Military Medical City, Saudi Arabia, between May and December 2020 with 81 patients with diabetes who used the isCGM system ( n = 30) or conventional finger-pricking SMBG system ( n = 51). At the same visit, venous and capillary blood samples were taken for routine HbA1c analysis by the standard laboratory and POCT methods, respectively. Also, for isCGM users, the GMI data for 28 days (GMI-28) and 90 days (GMI-90) were obtained, while for SMBG users, eAG data for 30 days (eAG-30) and 90 days (eAG-90) were calculated. The limits of agreement in different HbA1c measurements were evaluated using a Bland-Altman analysis. Pearson correlation and multivariate linear regression analyses were also performed. Results Based on the Bland-Altman analysis, HbA1c levels for 96.7% and 96.1% of the patients analyzed by the POCT and the standard laboratory methods were within the range of the 95% limit of agreement in both isCGM and conventional SMBG users, respectively. About 93.3% of the GMI measurements were within the 95% limit of agreement. Also, about 94.12% of the eAG-30 and 90.2% of the eAG-90 measurements were within the 95% limit of agreement. Moreover, the correlation analysis revealed a statistically significant positive correlation and linear regression among Lab-HbA1c, POCT-HbA1c, GMI, and eAG in both conventional SMBG and isCGM users (all p < 0.001). These positive results persisted significantly after adjusting for different factors (all p < 0.001). Conclusion GMI derived by isCGM or eAG derived by conventional SMBG systems, as well as the POCT-HbA1c measurements, showed a high level of agreement; therefore, we recommend them as potential methods for diabetes monitoring, especially when a rapid result is needed or with patients with uncontrolled diabetes or on intensive insulin therapy.

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Section: Introductionmentioning

confidence: 99%

“…Over half of all people with diabetes are undiagnosed, and only one-third have good disease control. Individuals with untreated or uncontrolled DM are more likely to develop long-term consequences and die prematurely because of cardiovascular and infectious diseases (e.g., tuberculosis and COVID-19) [2][3][4][5][6]. With a regional incidence of 16.2% and the second-highest forecasted rise (86%) in the number of people with DM, the Middle East and North African (MENA) area is estimated to have 136 million patients with DM by 2045 [7].…”

Section: Introductionmentioning

confidence: 99%

“…According to a WHO survey, 14.4% of Saudi Arabians were estimated to have DM [9]. Glycated hemoglobin A1c (HbA1c) is a reference metric for the circulating blood glucose concentration across the lifecycle of the RBC [10], and it has a substantial predictive value for DM-related complications [6,11,12]. In order to correctly adapt treatment, HbA1c monitoring is required.…”

Section: Introductionmentioning

confidence: 99%

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Comparison of Point-of-Care and Laboratory Glycated Hemoglobin A1c and Its Relationship to Time-in-Range and Glucose Variability: A Real-World Study

Hayek¹,

Alzahrani²,

Sobki³

et al. 2023

Cureus

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Introduction The main objective of the current study was to perform a comparison of point-of-care testing for hemoglobin A1c (POCT-HbA1c) versus the standard laboratory method (Lab HbA1c) and their relationship to time-in-range (TIR) and glucose variability (GV) among patients with diabetes mellitus (DM) presented to the outpatient diabetes clinics. Methods This single-center cross-sectional study was carried out on diabetic patients (aged ≥14 years of both genders) who undergo routine follow-up at our institution and whose physicians ordered HbA1c analysis for routine care. The included patients were those using the intermittently scanned continuous glucose monitoring (isCGM) Abbott’s FreeStyle Libre system for at least three months and regular CGM users with at least 70% use. Results We included 97 diabetic patients (41 female and 56 male), with a median age of 25 years (Interquartile range= 18) and a mean DM duration of 10.33±5.48 years. The mean values of Lab-HbA1c and POCT HbA1c were 8.82%±0.85% and 8.53%±0.89%, respectively. The TIR, time below range, and time above range were 33.47±14.38 minutes (47.78%±14.32%), 5.44±2.58 minutes (8.41%±4.42%), and 28.8±8.27 minutes (43.81%±13.22%), respectively. According to the Bland-Altman plot analysis, the POCT-HbA1c values are consistent with the standard Lab-HbA1c values (SD of bias= 0.55, and 95% CI= -0.78 to 1.4). The univariate linear regression analysis showed a statistically significant relationship between laboratory HbA1c and POCT HbA1c (R2= 0.637, p <0.001), TIR (R2= 0.406, p <0.001), and GV (R2= 0.048, p = 0.032). After adjusting for age, gender, disease duration, diabetes type, and percentage of sensor data in a multivariable linear regression model, the linear associations remained significant (all p < 0.05). Conclusion The current findings show that TIR and GV can be used as endpoints and valuable parameters for the therapy of DM.

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Efficacy and safety of imeglimin in patients with type 2 diabetes mellitus: A systematic review and meta-analysis of randomized clinical trials

Cited by 21 publications

References 19 publications

Treatment of diabetes mellitus has borne much fruit in the prevention of cardiovascular disease

Treatment of diabetes mellitus has borne much fruit in the prevention of cardiovascular disease

Level of Agreement and Correlation Between the Estimated Hemoglobin A1c Results Derived by Continuous or Conventional Glucose Monitoring Systems Compared with the Point-of-Care or Laboratory-Based Measurements: An Observational Study

Comparison of Point-of-Care and Laboratory Glycated Hemoglobin A1c and Its Relationship to Time-in-Range and Glucose Variability: A Real-World Study

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