Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04531631
Other study ID # CRE-2020.196
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date September 30, 2020
Est. completion date February 15, 2022

Study information

Verified date July 2022
Source Chinese University of Hong Kong
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 18
Est. completion date February 15, 2022
Est. primary completion date February 15, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: 1. Individuals aged = 18 years but < 65years 2. Male or female 3. Body mass index of over 18 kg/m2 and < 30 kg/m2 Additional Inclusion criteria for recent-onset T2D group - Diagnosis of T2D for at least 3 months and less than 2 years - On diet control only - HbA1c>6.5 % and <8% Additional Inclusion criteria for GK MODY-2 group - Abnormal fasting plasma glucose >5.6 mmol/l and known heterozygous carrier of pathogenic GK mutation Exclusion Criteria: 1. Subjects who do not agree to participate in this study. 2. Country of birth is unknown 3. Body weight less than 45kg 4. Acute phase of cerebrovascular and cardiovascular diseases (within 6 months of recruitment). 5. Subjects with severe renal dysfunction as defined by eGFR <30 ml/min/1.73m2 or patients receiving renal dialysis (such as haemodialysis or continuous ambulatory peritoneal dialysis). 6. Severe hepatic dysfunction as defined by AST and/or ALT > 3 times upper limit of normal 7. Severe cardiovascular disease, history of stroke, heart failure (NYHA III or IV) or history of myocardial infarction within last 12 months 8. History of drug abuse or excessive alcohol intake based on investigator judgment 9. Severe hypoglycaemia resulting in seizure/unconsciousness/coma/hospitalization in the last 3 months before screening 10. Diagnosis with Type 1 Diabetes Mellitus (T1DM) or any previous episodes of diabetic ketoacidosis. 11. Dehydration, diarrhoea or vomiting at the time of recruitment 12. Subjects with severe infection, in perioperative period or with serious injury at the time of recruitment 13. Subjects with anaemia (Haemoglobin <9.0mg/dL) 14. Pregnant or lactating or intending to become pregnant within 30 days after last dose of study drug. 15. Participation in a clinical trial within 30 days before enrolment 16. Donation or loss of blood (excluding the volume of blood that will be drawn during screening procedures) as follows: >=300 mL of blood within 30 days prior to study drug administration. 17. Subjects judged unsuitable for the study based on investigator judgment 18. Use of metformin, sulfonylureas, dipeptidyl peptidase-4 inhibitors, glucagon-like peptide 1 [GLP-1] agonists, sodium glucose transporter 2 inhibitors, insulin, thiazolidinediones, acarbose in the 3 months prior to study enrolment will not be permitted. 19. Use of strong or moderate CYP3A4 inhibitors or inducers and cannot be discontinued 20. Unwilling or unable to follow protocol requirements.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Dorzagliatin
tablet
placebo
placebo

Locations

Country Name City State
Hong Kong The Chinese University of Hong Kong Hong Kong

Sponsors (1)

Lead Sponsor Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type Measure Description Time frame Safety issue
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
Secondary Maximum concentration (Cmax) 1st phase insulin between 0 to 10 minutes measure insulin between 0 to 10 minutes 10 mins
Secondary Time to maximum (Tmax) of acute phase insulin response between 0 to 10 minutes measure insulin between 0 to 10 minutes 10 mins
Secondary Second phase insulin response measure insulin at last 40 mins of hyperglycemic clamp 40 mins
Secondary Beta cell glucose sensitivity insulin secretion in last 40 minutes of hyperglycemic clamp 40 mins
Secondary Insulin sensitivity index glucose infusion rate in last 40 minutes of hyperglycemic clamp 40 mins
Secondary Area under curve of glucagon levels measure glucagon from 0-120 mins 120 mins
Secondary Area under curve of GLP-1 levels measure GLP-1 from 0-120 mins 120 mins
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05666479 - CGM Monitoring in T2DM Patients Undergoing Orthopaedic Replacement Surgery
Completed NCT05647083 - The Effect of Massage on Diabetic Parameters N/A
Active, not recruiting NCT05661799 - Persistence of Physical Activity in People With Type 2 Diabetes Over Time. N/A
Completed NCT03686722 - Effect of Co-administration of Metformin and Daclatasvir on the Pharmacokinetis and Pharmacodynamics of Metformin Phase 1
Completed NCT02836704 - Comparison of Standard vs Higher Starting Dose of Insulin Glargine in Chinese Patients With Type 2 Diabetes (Glargine Starting Dose) Phase 4
Completed NCT01819129 - Efficacy and Safety of FIAsp Compared to Insulin Aspart in Combination With Insulin Glargine and Metformin in Adults With Type 2 Diabetes Phase 3
Completed NCT04562714 - Impact of Flash Glucose Monitoring in People With Type 2 Diabetes Using Non-Insulin Antihyperglycemic Therapy N/A
Completed NCT02009488 - Treatment Differences Between Canagliflozin and Placebo in Insulin Secretion in Subjects With Type 2 Diabetes Mellitus (T2DM) Phase 1
Completed NCT05896319 - Hyaluronic Acid Treatment of the Post-extraction Tooth Socket Healing in Subjects With Diabetes Mellitus Type 2 N/A
Recruiting NCT05598203 - Effect of Nutrition Education Groups in the Treatment of Patients With Type 2 Diabetes N/A
Completed NCT05046873 - A Research Study Looking Into Blood Levels of Semaglutide and NNC0480-0389 When Given in the Same Injection or in Two Separate Injections in Healthy People Phase 1
Completed NCT04030091 - Pulsatile Insulin Infusion Therapy in Patients With Type 1 and Type 2 Diabetes Mellitus Phase 4
Terminated NCT04090242 - Impact of App Based Diabetes Training Program in Conjunction With the BD Nano Pen Needle in People With T2 Diabetes N/A
Completed NCT03604224 - A Study to Observe Clinical Effectiveness of Canagliflozin 300 mg Containing Treatment Regimens in Indian Type 2 Diabetes Participants With BMI>25 kg/m^2, in Real World Clinical Setting
Completed NCT03620357 - Continuous Glucose Monitoring & Management In Type 2 Diabetes (T2D) N/A
Completed NCT01696266 - An International Survey on Hypoglycaemia Among Insulin-treated Patients With Diabetes
Completed NCT03620890 - Detemir Versus NPH for Type 2 Diabetes Mellitus in Pregnancy Phase 4
Withdrawn NCT05473286 - A Research Study Looking at How Oral Semaglutide Works in People With Type 2 Diabetes in Germany, as Part of Local Clinical Practice
Not yet recruiting NCT05029804 - Effect of Walking Exercise Training on Adherence to Disease Management and Metabolic Control in Diabetes N/A
Completed NCT04183257 - Effect of Escalating Oral Vitamin D Replacement on HOMA-IR in Vitamin D Deficient Type 2 Diabetics Phase 4