Glucose IntolerancePhase 1/2NCT05468229
Dorzagliatin and 1st Phase Insulin and Beta-cell Glucose Sensitivity in IGT and NGT
A Phase 1/2 study testing Dorzagliatin in people with Glucose Intolerance, run by Chinese University of Hong Kong.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Glucose Intolerance
- 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
- 20 participants
- Where
- No sites listed yet
- Study dates
- Aug 2022to Apr 2023
- Phase
- Phase 1/2
- 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
- Healthy volunteers accepted
- 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 IGT group
- Fasting plasma glucose <7.0 mmol/L and HbA1c < 6.5%
- 2 hour plasma glucose ≥7.8 and <11.1 mmol/L on 75g oral glucose tolerance test (OGTT)
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- Never been treated with glucose lowering drugs (including traditional Chinese medicine for glycemic control)
- Additional inclusion criteria for NGT group
- Fasting plasma glucose <5.6 mmol/L and HbA1c < 5.7%
- 2 hour plasma glucose <7.8 mmol/L on 75g oral glucose tolerance test (OGTT)
- Never been treated with glucose lowering drugs (including traditional Chinese medicine for glycemic control
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.
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- 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.
- History of diabetes mellitus.
- 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 <11.0mg/dL or haematocrit <0.35 ) at screening, known iron deficiency, haemoglobinopathies or anaemia due to chronic disease.
- Pregnant or lactating or intending to become pregnant within 30 days after last dose of study drug.
- Participation in a clinical trial with investigational product 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 strong or moderate CYP3A4 inhibitors or inducers and cannot be discontinued.
- Unwilling or unable to follow protocol requirements
About this study
Official title: Effects of Dorzagliatin on 1st Phase Insulin and Beta-cell Glucose Sensitivity in Individuals With Impaired and Normal Glucose Tolerance
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.
Read the detailed 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.
- Conditions
- Glucose Intolerance
- Being tested
- Dorzagliatin, Placebo
- Medical subject headings
- Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DorzagliatinDrug
single oral dose of dorzagliatin 50 mg
PlaceboDrug
Matching placebo
| Study group | Role | What they receive |
|---|---|---|
| dorzagliatin | Active comparator | Dorzagliatin 50 mg single dose Receives: Drug: Dorzagliatin |
| placebo | Placebo comparator | matching placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-hour hyperglycemic clamp
first phase insulin secretion
Measured: 2-hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2022
- Study startAug 2022 (estimated)
- Primary completionApr 2023 (estimated)
- Study completionApr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glucose IntoleranceStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juliana Chan, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05468229
- Sponsor's protocol ID
- 2021.516-T
- Status last verified
- Jul 2022
- First submitted
- 19 Jul 2022
- Last updated
- 25 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Dorzagliatin on 1st Phase Insulin and Beta-cell Glucose Sensitivity in Individuals With Impaired and Normal Glucose Tolerance
- ClinicalTrials.gov ID
- NCT05468229
- Acronym / sponsor ID
- 2021.516-T
- Conditions
- Glucose Intolerance
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- Aug 2022 (estimated)
- Primary completion
- Apr 2023 (estimated)
- Study completion
- Apr 2023 (estimated)
- First posted
- 21 Jul 2022 (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.
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.
Detailed 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dorzagliatin | Active comparator | Drug: DorzagliatinDorzagliatin 50 mg single dose |
| placebo | Placebo comparator | Drug: Placebomatching placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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 IGT group
- Fasting plasma glucose <7.0 mmol/L and HbA1c < 6.5%
Key exclusion criteria (18 listed)
- 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).
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 |
|---|---|---|
| Dorzagliatinsingle oral dose of dorzagliatin 50 mg | Drug | dorzagliatin |
| PlaceboMatching placebo | Drug | placebo |
Primary outcome
2-hour hyperglycemic clamp
Time frame: 2-hour
first phase insulin secretion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2022.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Dorzagliatin in people with Glucose Intolerance, run by Chinese University of 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 11 inclusion and 18 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 25 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Results are not available in the source record.
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?
2-hour hyperglycemic clamp (time frame: 2-hour). 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 25 Jul 2022.