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<p>Glucokinase enzyme plays a pivotal&#xa0;role in various physiological processes such as glucose metabolism, inflammation, and immunity. AZD1656 is a glucokinase activator (GKA) that shows proven efficacy in reducing blood glucose. It also possesses a marked interest in autoimmune diseases due to its immunomodulatory effect. Six databases were searched: PubMed, Scopus, the Cochrane Library, World of Science, ClinicalTrials.gov, and AstrazenecaClinicalTrials.com. This meta-analysis was conducted by following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA). Twenty-three randomized controlled trials were included in this systematic review, and 19 studies were included in the meta-analysis. There was no significant difference between AZD1656 and placebo. Regarding total non-serious adverse events (a/e), the cumulative relative risk (RR) was 1.09 (95% CI 0.96–1.24, I<sup>2</sup> = 30%, <i>p</i> = 0.19). The RR for low doses (&lt; 100 mg), medium doses (≥ 100 and &lt; 200 mg), and high doses (≥ 200 mg) were 1.17 (95% CI 0.98–1.40, I<sup>2</sup> = 21%, <i>p</i> = 0.08), 1.19 (95% CI 0.96–1.48, I<sup>2</sup> = 49%, <i>p</i> = 0.18), and 1.06 (95% CI 0.78–1.43, I<sup>2</sup> = 34%, <i>p</i> = 0.72), respectively. For hypoglycaemic events, the cumulative RR was 2.03 (95% CI 0.94–4.39, I<sup>2</sup> = 0%, <i>p</i> = 0.07). The RR for low doses, medium doses, and high doses were 2.59 (95% CI 0.59–11.43, I<sup>2</sup> = 0%, <i>p</i> = 0.21), 2.48 (95% CI 0.80–7.72, I<sup>2</sup> = 0%, <i>p</i> = 0.16), and 2.17 (95% CI 0.28–16.47, I<sup>2</sup> = 0%, <i>p</i> = 0.46), respectively. The cumulative RR for serious a/e was 0.85 (95% CI 0.21–3.48, I<sup>2</sup> = 0%). AZD1656 is a well-tolerated, safe glucokinase activator. It has promising potential as an anti-diabetic and immunomodulatory agent, supporting its further investigation in immunomodulatory and inflammatory diseases.</p>

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Safety profile of glucokinase activator AZD1656: systematic review and meta-analysis of 23 randomised trials in diabetic and healthy volunteers with relevance to immunomodulatory therapy

  • 期刊论文

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  • 发表日期：

    2025年7月8日

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  • Mohamed M. Elsayed,
  • Mohamed M. Abdalla

摘要

Glucokinase enzyme plays a pivotal role in various physiological processes such as glucose metabolism, inflammation, and immunity. AZD1656 is a glucokinase activator (GKA) that shows proven efficacy in reducing blood glucose. It also possesses a marked interest in autoimmune diseases due to its immunomodulatory effect. Six databases were searched: PubMed, Scopus, the Cochrane Library, World of Science, ClinicalTrials.gov, and AstrazenecaClinicalTrials.com. This meta-analysis was conducted by following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA). Twenty-three randomized controlled trials were included in this systematic review, and 19 studies were included in the meta-analysis. There was no significant difference between AZD1656 and placebo. Regarding total non-serious adverse events (a/e), the cumulative relative risk (RR) was 1.09 (95% CI 0.96–1.24, I2 = 30%, p = 0.19). The RR for low doses (< 100 mg), medium doses (≥ 100 and < 200 mg), and high doses (≥ 200 mg) were 1.17 (95% CI 0.98–1.40, I2 = 21%, p = 0.08), 1.19 (95% CI 0.96–1.48, I2 = 49%, p = 0.18), and 1.06 (95% CI 0.78–1.43, I2 = 34%, p = 0.72), respectively. For hypoglycaemic events, the cumulative RR was 2.03 (95% CI 0.94–4.39, I2 = 0%, p = 0.07). The RR for low doses, medium doses, and high doses were 2.59 (95% CI 0.59–11.43, I2 = 0%, p = 0.21), 2.48 (95% CI 0.80–7.72, I2 = 0%, p = 0.16), and 2.17 (95% CI 0.28–16.47, I2 = 0%, p = 0.46), respectively. The cumulative RR for serious a/e was 0.85 (95% CI 0.21–3.48, I2 = 0%). AZD1656 is a well-tolerated, safe glucokinase activator. It has promising potential as an anti-diabetic and immunomodulatory agent, supporting its further investigation in immunomodulatory and inflammatory diseases.