Diabetes MellitusNCT06671340
Chronic Dorzagliatin on Insulin and Incretin Function in Intermediate Hyperglycemia and Type 2 Diabetes
A study testing Dorzagliatin in people with Diabetes Mellitus and Prediabetes / Type 2 Diabetes, run by Elaine Chow at 1 site in Hong Kong.
Trial summary
A total of 30 subjects will be recruited 15 with intermediate hyperglycemia and 15 in the tyep 2 diabetes group respectively. Eligible participants will undergo hyperglycemic-clamp/oral glucose tolerance at baseline and after 4 weeks of dorzagliatin treatment. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetes Mellitus, Prediabetes / Type 2 Diabetes
- What is being tested?
- Dorzagliatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteHong Kong
- Study dates
- 2 Apr 2025to 31 Jan 2026
- Phase
- Interventional
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals aged ≥ 18 years but < 70 years
- Male or female
- Body mass index of over 18 kg/m2 and < 35 kg/m2
- Additional inclusion criteria for IH group
- Fasting plasma glucose <7.0 mmol/L and HbA1c < 6.5%
- 1 hour plasma glucose ≥8.6 and <11.6 mmol/L on 75g oral glucose tolerance test (OGTT)
Show all 10Show fewer
- No use of glucose lowering drugs in past 6 months
- Additional inclusion criteria for T2D group
- HbA1c 6.5 to 10% at screening
- On diet control, or stable dose of oral glucose lowering drugs metformin for at least 8 weeks
Who cannot join
- 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 aspartate aminotransferase (AST) and/or alanine aminotransferase (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. Dehydration, diarrhoea or vomiting at the time of recruitment. 10. Subjects with severe infection, in perioperative period or with serious injury at the time of recruitment.
Show all 11Show fewer
- 11. Subjects with anaemia (Haemoglobin <9.0mg/dL). 12. Pregnant or lactating or intending to become pregnant within 30 days after last dose of study drug.
- 13. Participation in a clinical trial with investigational product within 30 days before enrolment.
- 14. 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.
- 15. Subjects judged unsuitable for the study based on investigator judgment. 16. Use of strong or moderate CYP3A4 inhibitors or inducers and cannot be discontinued.
- 17. Unwilling or unable to follow protocol requirements.
Trial locations and contacts
1 site in 1 country.
Elaine Chow contact
Hong Kong1 site
Phase 1 Clinical Trial Centre
Hong Kong
Michelle Wong, +852 35051641, michellewong27@cuhk.edu.hk
About this study
Official title: Effects of Repeated Dose of Dorzagliatin on Insulin Secretion, Glucagon Release and Incretin Function in Intermediate Hyperglycemia and Type 2 Diabetes
A total of 30 subjects will be recruited 15 with intermediate hyperglycemia and 15 in the tyep 2 diabetes group respectively. Eligible participants will undergo hyperglycemic-clamp/oral glucose tolerance at baseline and after 4 weeks of dorzagliatin treatment.
- Conditions
- Diabetes Mellitus, Prediabetes / Type 2 Diabetes
- Being tested
- Dorzagliatin
- Keywords
- clamp, diabetes, glucokinase activator
- Medical subject headings
- Diabetes Mellitus, Prediabetic State, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DorzagliatinDrug
chronic treatment with dorzagliatin for 4 weeks (50mg twice daily or 75mg twice daily, oral)
| Study group | Role | What they receive |
|---|---|---|
| IH/T2D | Experimental | partipiants with intermediate hyperglycemia (IH) n=15 or T2D (n=15) Receives: Drug: Dorzagliatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute Insulin secretion
Acute (first phase) insulin response (AIRg) to glucose will be calculated as the mean incremental responses above baseline (average of -20 and -10 and 0 minutes) to the samples drawn at 2, 4, 6, 8 and 10 minutes of the hyperglycemic clamp.
Measured: At baseline and after 4 weeks of study drug treatment
Secondary outcomes (5)
Second phase insulin secretion
The mean incremental insulin levels between 60 to 90 minutes of hyperglycemic clamp
Measured: At baseline and after 4 weeks of study drug treatment
Beta cell glucose sensitivity
Beta cell glucose sensitivity will be calculated as increment of insulin secretion in 60-90 minutes of the clamp minus basal insulin divided by glucose change in the same period
Measured: At baseline and after 4 weeks of study drug treatment
Glucagon-like peptide -1 (GLP-1)
GLP-1 secretion Area under the curve (0-270 minute during hyperglyemic- OGTT clamp study)
Measured: At baseline and after 4 weeks of study drug treatment
Glucagon
Glucagon area under the curve (0-270 minute) during hyperglyemic- OGTT clamp
Measured: At baseline and after 4 weeks of study drug treatment
Incretin effect
Difference between the post prandial (100-270min) and preprandial (60-90min) C peptide response
Measured: At baseline and after 4 weeks of study drug treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2024
- Study start2 Apr 2025 (estimated)
- Primary completion30 Dec 2025 (estimated)
- Study completion31 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Elaine Chow
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Elaine Chow, Chinese University of Hong Kong
- Investigators
- Elaine Chow, MBChB, PhD, FRCP, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06671340
- Sponsor's protocol ID
- SENSITISE-3
- Status last verified
- Oct 2024
- First submitted
- 30 Oct 2024
- Last updated
- 4 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Repeated Dose of Dorzagliatin on Insulin Secretion, Glucagon Release and Incretin Function in Intermediate Hyperglycemia and Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT06671340
- Acronym / sponsor ID
- SENSITISE-3
- Conditions
- Diabetes Mellitus, Prediabetes / Type 2 Diabetes
- Keywords
- clamp, diabetes, glucokinase activator
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Elaine ChowUniversity, hospital or other
- Study start
- 2 Apr 2025 (estimated)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 31 Jan 2026 (estimated)
- First posted
- 4 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A total of 30 subjects will be recruited 15 with intermediate hyperglycemia and 15 in the tyep 2 diabetes group respectively. Eligible participants will undergo hyperglycemic-clamp/oral glucose tolerance at baseline and after 4 weeks of dorzagliatin treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IH/T2D | Experimental | Drug: Dorzagliatinpartipiants with intermediate hyperglycemia (IH) n=15 or T2D (n=15) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Individuals aged ≥ 18 years but < 70 years
- Male or female
- Body mass index of over 18 kg/m2 and < 35 kg/m2
- Additional inclusion criteria for IH group
- Fasting plasma glucose <7.0 mmol/L and HbA1c < 6.5%
Key exclusion criteria (11 listed)
- 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 aspartate aminotransferase (AST) and/or alanine aminotransferase (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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dorzagliatinchronic treatment with dorzagliatin for 4 weeks (50mg twice daily or 75mg twice daily, oral) | Drug | IH/T2D |
Primary outcome
Acute Insulin secretion
Time frame: At baseline and after 4 weeks of study drug treatment
Acute (first phase) insulin response (AIRg) to glucose will be calculated as the mean incremental responses above baseline (average of -20 and -10 and 0 minutes) to the samples drawn at 2, 4, 6, 8 and 10 minutes of the hyperglycemic clamp.
5 secondary outcomes
Second phase insulin secretion
Time frame: At baseline and after 4 weeks of study drug treatment
Beta cell glucose sensitivity
Time frame: At baseline and after 4 weeks of study drug treatment
Glucagon-like peptide -1 (GLP-1)
Time frame: At baseline and after 4 weeks of study drug treatment
Glucagon
Time frame: At baseline and after 4 weeks of study drug treatment
Incretin effect
Time frame: At baseline and after 4 weeks of study drug treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2025.
- Individual participant dataSharing planned: Yes
Related trials for Diabetes Mellitus
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elaine Chow contact
Elaine Chow, MBChB, PhD, FRCP principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dorzagliatin in people with Diabetes Mellitus and Prediabetes / Type 2 Diabetes, run by Elaine Chow 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 10 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 4 Mar 2025. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elaine Chow (+852 35051641, e.chow@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute Insulin secretion (time frame: At baseline and after 4 weeks of study drug treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Mar 2025.