CLINICAL TRIALS PROFILE FOR DORZAGLIATIN
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Clinical Trials for Dorzagliatin
| Trial ID | Title | Status | Sponsor | Phase | Summary |
|---|---|---|---|---|---|
| NCT03790787 ↗ | Drug Interaction Study Between Dorzagliatin and Empagliflozin | Completed | Hua Medicine Limited | Phase 1 | This is a Phase 1, open-label, sequential, multiple-dose, drug interaction study of glucokinase activator dorzagliatin and empagliflozin in subjects with T2DM. Pharmacokinetics and pharmacodynamics when dorzagliatin and empagliflozin given alone and in combination will be studied. |
| NCT03790839 ↗ | Drug Interaction Study Between Dorzagliatin and Sitagliptin | Completed | Hua Medicine Limited | Phase 1 | This is a Phase 1, open-label, sequential, multiple-dose, drug interaction study of glucokinase activator dorzagliatin and sitagliptin in subjects with T2DM. Pharmacokinetics and pharmacodynamics when dorzagliatin and sitagliptin given alone and in combination will be studied. |
| NCT04080596 ↗ | DDI Study to Investigate the Impact of Itraconazole on the Pharmacokinetics of Dorzagliatin | Completed | Hua Medicine Limited | Phase 1 | The purpose of this study is to investigate the impact of itraconzaole on the pharmacokinetics of Dorzagliatin. |
| NCT04080609 ↗ | DDI Study Between Dorzagliatin and Rifampicin | Completed | Hua Medicine Limited | Phase 1 | The purpose of this drug-drug interaction study is to investigate the impact of rifampicin on the pharmacokinetics of Dorzagliatin. |
| NCT04531631 ↗ | Effects of Dorzagliatin on 1st Phase Insulin and Beta-cell Glucose Sensitivity in Individuals With Recent-onset Type 2 Diabetes and Monogenic Diabetes | Recruiting | Chinese University of Hong Kong | Phase 2 | Diabetes is a disorder of energy energy metabolism. Glucose is the main energy substrate for generation of ATP to maintain cellular metabolism, structure and function. Glucokinase (GK) serves as a glucose sensor for the initiation of the energy generation.for energy metabolism. Dorzagliatin is a novel, first-in-class, dual-acting allosteric GK activator (GKA). It increases the affinity of GK for glucose by directly binding a pocket distal to its active site, thus lowering the set point for glucose-stimulated insulin secretion in the beta-cell. Dorzagliatin is a new drug which acts as GK sensor activator (GKA). It can restore the sensitivity of the pancreas cells to glucose and improve glucose control. The drug has been trialled in healthy volunteers and in individuals with type 2 diabetes. The aim of this study is to understand the way in which dorzagliatin works to improve blood sugar control in people with diabetes. The study will look at how dorzagliatin affects insulin secretion and the sensitivity of the pancreas to changes in blood sugar levels. We will examine whether dorzagliatin can restore the function of this GK sensor in patients with known mutations. In a cross-over study, we will evaluate the effects of dorzagliatin, a specific GKA versus placebo in terms of insulin secretion and beta-cell glucose sensitivity in patients with newly-diagnosed T2D and patients who are known heterozygous carriers of GK mutations. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Summary |
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