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Dorzagliatin and 1st Phase Insulin and Beta-cell Glucose Sensitivity in IGT and NGT

Glucose Intolerance Clinical Trial

Official title:
Effects of Dorzagliatin on 1st Phase Insulin and Beta-cell Glucose Sensitivity in Individuals With Impaired and Normal Glucose Tolerance

Clinical Trial Summary

Dorzagliatin, a novel dual allosteric activator of glucokinase. reduces blood glucose by increasing insulin secretion by enhancing sensitivity of beta cells to glucose. In this placebo controlled cross over study, we examined the effects of dorzagliatin in people with impaired glucose tolerance and normal glucose tolerance.

Clinical Trial Description

Objective To investigate the acute effects of a single dose dorzagliatin on first phase insulin secretion and beta cell glucose sensitivity (βCGS) in individuals with impaired and normal glucose tolerance Methodology and rationale: A total of 20 subjects will be recruited, 10 in impaired glucose tolerant (IGT) and 10 in normal glucose tolerant (NGT) groups, respectively. Eligible participants will have a two-hour hyperglycemic clamp following a single dose of dorzagliatin or placebo in a randomized crossover fashion on V2 or V3. Subjects will be randomized to dorzagliatin 50mg or placebo in the IGT and NGT groups. Arterialized blood glucose (venous blood drawn from back of the hand placed in a temperature regulated box), measured every 5 minutes at the bedside Yellow Spring Instrument (YSI) or EKF glucose analyser, will be maintained at 12 mmol/l using an infusion of dextrose. Blood will be sampled for insulin and C-peptide at regular intervals for evaluation of first and second phase insulin secretion. Glucagon-like peptide-1 (GLP-1) and glucagon will be evaluated at regular intervals during the clamp studies. After 14 ± 2 days washout out (Day 14), participants will receive a single dose of dorzagliatin or matched placebo followed by a repeat hyperglycemic clamp to evaluate differences in beta-cell function. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05468229
Study type Interventional
Source Chinese University of Hong Kong
Contact
Status Not yet recruiting
Phase Phase 1/Phase 2
Start date August 2022
Completion date April 2023
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