The efficacy and safety of glucokinase activators for the treatment of type-2 diabetes mellitus A protocol for systematic review and meta-analysis

Background: Glucokinase activators are a novel family of glucose-lowering agents used for the treatment of type-2 diabetes mellitus (T2DM). Glucokinase activators blind to GK activate the enzyme allosterically. Treatment with different GKAs has been shown to reduce fasting and postprandial glucose in patients with type 2 diabetes. We compared the efficacy/safety of glucokinase activators in T2DM patients through a meta-analysis. Methods: We searched PubMed, Excerpt Medica Database, and Cochrane Central Register of Controlled Trials databases for articles published before December 30, 2020. Two independent reviewers extracted the information from article. The quality of articles were assessed by 2 independent reviewers using the 5 items of scale proposed by Jadad. We computed the weighted mean difference and 95% confidence interval (CI) for a change from baseline to the study endpoint for glucokinase activators vs placebo. Egger test and Begg test were used to assess the possible publication bias caused by the tendency of published studies to be positive. Results: The present meta-analysis will compare the efficacy and safety of glucokinase activators and placebo for the treatment of T2DM. Conclusions: This meta-analysis will provide advanced evidence on the efficacy and safety of glucokinase activators for the treatment of T2DM. Ethics and dissemination: Ethical approval and patient consent are not required because this study is a literature-based study. This systematic review and meta-analysis will be published in a peer-reviewed journal PROSPERO registration number: CRD42021220364.