Clinical Trial Details
| Trial ID: | L5913 |
| Source ID: | NCT04531631 |
| Associated Drug: | Dorzagliatin |
| Title: | Effects of Dorzagliatin on 1st Phase Insulin and Beta-cell Glucose Sensitivity in T2D and Monogenic Diabetes |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | NO |
| Results: | |
| Conditions: | Diabetes Mellitus, Type 2 |
| Interventions: | DRUG: Dorzagliatin|DRUG: placebo |
| Outcome Measures: | Primary: first phase insulin response to glucose, measure insulin between 0 to 10 minutes, 10 mins | Secondary: First phase C-peptide responses to glucose, measure C peptide between 0 to 10 minutes, 10 mins|Maximum concentration (Cmax) 1st phase insulin between 0 to 10 minutes, measure insulin between 0 to 10 minutes, 10 mins|Time to maximum (Tmax) of acute phase insulin response between 0 to 10 minutes, measure insulin between 0 to 10 minutes, 10 mins|Second phase insulin response, measure insulin at last 40 mins of hyperglycemic clamp, 40 mins|Beta cell glucose sensitivity, insulin secretion in last 40 minutes of hyperglycemic clamp, 40 mins|Insulin sensitivity index, glucose infusion rate in last 40 minutes of hyperglycemic clamp, 40 mins|Area under curve of glucagon levels, measure glucagon from 0-120 mins, 120 mins|Area under curve of GLP-1 levels, measure GLP-1 from 0-120 mins, 120 mins |
| Sponsor/Collaborators: | Sponsor: Chinese University of Hong Kong |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE2 |
| Enrollment: | 18 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: OTHER |
| Start Date: | 2020-09-30 |
| Completion Date: | 2022-02-15 |
| Results First Posted: | |
| Last Update Posted: | 2022-07-22 |
| Locations: | The Chinese University of Hong Kong, Hong Kong, Hong Kong |
| URL: | https://clinicaltrials.gov/show/NCT04531631 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
|---|