AzTrials
AzTrials

Diabetes Mellitus, Type 2Phase 2NCT04531631

Effects of Dorzagliatin on 1st Phase Insulin and Beta-cell Glucose Sensitivity in T2D and Monogenic Diabetes

A Phase 2 study testing Dorzagliatin in people with Diabetes Mellitus, Type 2, run by Chinese University of Hong Kong at 1 site in Hong Kong.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
Dorzagliatin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
18 participants
Where
1 siteHong Kong
Study dates
30 Sep 2020to 15 Feb 2022
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Individuals aged ≥ 18 years but < 65years
  • Male or female
  • 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

Who cannot join

  • Subjects who do not agree to participate in this study.
  • Country of birth is unknown
  • Body weight less than 45kg
  • Acute phase of cerebrovascular and cardiovascular diseases (within 6 months of recruitment).
  • 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).
  • Severe hepatic dysfunction as defined by AST and/or ALT > 3 times upper limit of normal
Show all 20Show fewer
  • Severe cardiovascular disease, history of stroke, heart failure (NYHA III or IV) or history of myocardial infarction within last 12 months
  • History of drug abuse or excessive alcohol intake based on investigator judgment
  • Severe hypoglycaemia resulting in seizure/unconsciousness/coma/hospitalization in the last 3 months before screening
  • Diagnosis with Type 1 Diabetes Mellitus (T1DM) or any previous episodes of diabetic ketoacidosis.
  • Dehydration, diarrhoea or vomiting at the time of recruitment
  • Subjects with severe infection, in perioperative period or with serious injury at the time of recruitment
  • Subjects with anaemia (Haemoglobin <9.0mg/dL)
  • Pregnant or lactating or intending to become pregnant within 30 days after last dose of study drug.
  • Participation in a clinical trial within 30 days before enrolment
  • 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.
  • Subjects judged unsuitable for the study based on investigator judgment
  • 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.
  • Use of strong or moderate CYP3A4 inhibitors or inducers and cannot be discontinued
  • Unwilling or unable to follow protocol requirements.

Trial locations and contacts

1 site in 1 country.

Hong Kong1 site

  • The Chinese University of Hong Kong

    Hong Kong

Other trials in Hong Kong

About this study

Official title: Effects of Dorzagliatin on 1st Phase Insulin and Beta-cell Glucose Sensitivity in Individuals With Recent-onset Type 2 Diabetes and Monogenic Diabetes

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.

Being tested
Dorzagliatin, placebo
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DorzagliatinDrug

    tablet

  • placeboDrug

    placebo

Study groups in NCT04531631
Study groupRoleWhat they receive
Group 1Otherreceive a single oral dose of dorzagliatin 75mg tablet on visit 2 and receive one placebo tablet on visit 3
Receives: Drug: Dorzagliatin; Drug: placebo
Group 2Otherreceive a single oral dose of one placebo tablet on visit 2 and receive dorzagliatin 75mg tablet on visit 3
Receives: Drug: Dorzagliatin; Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. first phase insulin response to glucose

    measure insulin between 0 to 10 minutes

    Measured: 10 mins

Secondary outcomes (8)

  1. First phase C-peptide responses to glucose

    measure C peptide between 0 to 10 minutes

    Measured: 10 mins

  2. Maximum concentration (Cmax) 1st phase insulin between 0 to 10 minutes

    measure insulin between 0 to 10 minutes

    Measured: 10 mins

  3. Time to maximum (Tmax) of acute phase insulin response between 0 to 10 minutes

    measure insulin between 0 to 10 minutes

    Measured: 10 mins

  4. Second phase insulin response

    measure insulin at last 40 mins of hyperglycemic clamp

    Measured: 40 mins

  5. Beta cell glucose sensitivity

    insulin secretion in last 40 minutes of hyperglycemic clamp

    Measured: 40 mins

  6. Insulin sensitivity index

    glucose infusion rate in last 40 minutes of hyperglycemic clamp

    Measured: 40 mins

  7. Area under curve of glucagon levels

    measure glucagon from 0-120 mins

    Measured: 120 mins

  8. Area under curve of GLP-1 levels

    measure GLP-1 from 0-120 mins

    Measured: 120 mins

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Aug 2020
  2. Study start30 Sep 2020
  3. Primary completion15 Feb 2022
  4. Study completion15 Feb 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Other
Allocation
Randomised
Intervention model
Crossover
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04531631
Sponsor's protocol ID
CRE-2020.196
Status last verified
Jul 2022
First submitted
26 Aug 2020
Last updated
22 Jul 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Dorzagliatin in people with Diabetes Mellitus, Type 2, run by Chinese University of Hong Kong at 1 site in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

first phase insulin response to glucose (time frame: 10 mins). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04531631.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in