Impaired Glucose TolerancePhase 2NCT04727580
HSK7653 in Chinese Patients with Impaired Glucose Tolerance
A Phase 2 study testing HSK7653 10mg Q2W and HSK7653 25mg Q2W in people with Impaired Glucose Tolerance, run by Haisco Pharmaceutical Group Co., Ltd. at 1 site in China.
Trial summary
This study is being done to evaluate the efficacy, safety of HSK7653 in chinese participants with impaired glucose tolerance. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Impaired Glucose Tolerance
- What is being tested?
- HSK7653 10mg Q2W and HSK7653 25mg Q2W
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 99 participants
- Where
- 1 siteChina
- Study dates
- 29 Mar 2021to 29 Jun 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Impaired glucose tolerance;
- BMI (Body Mass Index) in the range of ≥ 18.0 kg/m2 to ≤ 35.0 kg/m2 at screening;
Who cannot join
- History of diabetes mellitus;
- History of severe endocrine disease, uncured cancer, acute pancreatitis prior to informed consent;
- Current uncontrolled hypertension, serious nephropathy prior to informed consent;
- Serious Heart Failure (class III-IV of the New York Heart Association functional classification), serious Arrhythmia, and Stroke within 6 months prior to informed consent;
- Serious gastrointestinal disease within 2 weeks prior to informed consent;
- Serious infection, trauma, and surgery within 3 months prior to informed consent;
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- History of treatment with Glucagon-like peptide 1(GLP-1) analogues, Dipeptidyl-Peptidase 4(DPP-IV) inhibitor;
- Treatment with drugs that affect glucose metabolism within 8 weeks prior to informed consent;
- Hemoglobin (HGB) < 10.0 g/dL(100 g/L);
- Alcohol abuse within 6 months or drug abuse history within 5 years prior to informed consent;
- Active infectious diseases;
- Participation in another trial with an investigational drug or instrument within 3 months prior to informed consent;
- Women who are nursing or pregnant, or subjects with birth plans;
- Other protocol-defined inclusion/exclusion criteria.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-group Clinical Trial to Study the Efficacy and Safety of HSK7653 in Chinese Patients with Impaired Glucose Tolerance
This study is being done to evaluate the efficacy, safety of HSK7653 in chinese participants with impaired glucose tolerance.
- Conditions
- Impaired Glucose Tolerance
- Being tested
- HSK7653 10mg Q2W, HSK7653 25mg Q2W, Placebo
- Keywords
- Impaired Glucose Tolerance, DPP-4 inhibitor, Prediabetes
- Medical subject headings
- Glucose Intolerance, Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HSK7653 10mg Q2WDrug
HSK7653 5mg (2 tablets) and placebo of HSK7653 25mg (1 tablet) Q2W, oral, Day1 to week12
HSK7653 25mg Q2WDrug
HSK7653 25mg (1 tablet) and placebo of HSK7653 5mg (2 tablets) Q2W, oral, Day1 to week12
PlaceboDrug
Placebo of HSK7653 25mg (1 tablet) and placebo of HSK7653 5mg (2 tablets) Q2W, oral, Day1 to week12
| Study group | Role | What they receive |
|---|---|---|
| HSK7653 10 mg | Experimental | Not described Receives: Drug: HSK7653 10mg Q2W |
| HSK7653 25 mg | Experimental | Not described Receives: Drug: HSK7653 25mg Q2W |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Plasma Glucose AUC 0-3h for Meal Tolerance Test (MTT) at Week 12
Plasma glucose AUC 0-3 hours for MTT was measured at Baseline (Week 0) and at Week 12. After fasting for ≥8 hours, blood samples for glucose measurement were drawn at 0 minutes (at standard meal loading), 30 minutes, 60 minutes, 90 minutes, 120 minutes, and 180 minutes. At Week 12, participants received study drug or placebo 50 minutes prior to consuming a standard meal.
Measured: Baseline and Week 12
Secondary outcomes (10)
Change From Baseline in Insulin AUC 0-3h for Meal Tolerance Test (MTT) at Week 12
Measured: Baseline and Week 12
Change From Baseline in C-peptide AUC 0-3h for Meal Tolerance Test (MTT) at Week 12
Measured: Baseline and Week 12
Change From Baseline in Fasting Glucose at Week 12
Measured: Baseline and Week 12
Change From Baseline in Fasting Insulin at Week 12
Measured: Baseline and Week 12
Change From Baseline in Fasting C-peptide at Week 12
Measured: Baseline and Week 12
Change From Baseline in HOMA-IS at Week 12
Measured: Baseline and Week 12
Change From Baseline in HOMA-β at Week 12
Measured: Baseline and Week 12
Change From Baseline in Hemoglobin A1c (HbA1c) at Week 12
Measured: Baseline and Week 12
Change From Baseline in Plasma Glucose Area Under the Curve 0 to 3 Hours (AUC 0-3 Hrs) for Oral Glucose Tolerance Test (OGTT) at Week 10
Measured: Baseline and Week 10
Incidence of Treatment-Emergent Adverse Events
Measured: Baseline and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2021
- Study start29 Mar 2021
- Primary completion12 Jun 2022
- Study completion29 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Impaired Glucose ToleranceStudies of the same condition, open and under way.
- More trials run by Haisco Pharmaceutical Group Co., Ltd.The 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haisco Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04727580
- Sponsor's protocol ID
- HSK7653-202
- Status last verified
- Nov 2024
- First submitted
- 21 Jan 2021
- Last updated
- 25 Nov 2024
- 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 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-group Clinical Trial to Study the Efficacy and Safety of HSK7653 in Chinese Patients with Impaired Glucose Tolerance
- ClinicalTrials.gov ID
- NCT04727580
- Acronym / sponsor ID
- HSK7653-202
- Conditions
- Impaired Glucose Tolerance
- Keywords
- Impaired Glucose Tolerance, DPP-4 inhibitor, Prediabetes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Haisco Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 29 Mar 2021 (actual)
- Primary completion
- 12 Jun 2022 (actual)
- Study completion
- 29 Jun 2022 (actual)
- First posted
- 27 Jan 2021 (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.
This study is being done to evaluate the efficacy, safety of HSK7653 in chinese participants with impaired glucose tolerance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HSK7653 10 mg | Experimental | Drug: HSK7653 10mg Q2W |
| HSK7653 25 mg | Experimental | Drug: HSK7653 25mg Q2W |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Impaired glucose tolerance;
- BMI (Body Mass Index) in the range of ≥ 18.0 kg/m2 to ≤ 35.0 kg/m2 at screening;
Key exclusion criteria (14 listed)
- History of diabetes mellitus;
- History of severe endocrine disease, uncured cancer, acute pancreatitis prior to informed consent;
- Current uncontrolled hypertension, serious nephropathy prior to informed consent;
- Serious Heart Failure (class III-IV of the New York Heart Association functional classification), serious Arrhythmia, and Stroke within 6 months prior to informed consent;
- Serious gastrointestinal disease within 2 weeks prior to informed consent;
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 |
|---|---|---|
| HSK7653 10mg Q2WHSK7653 5mg (2 tablets) and placebo of HSK7653 25mg (1 tablet) Q2W, oral, Day1 to week12 | Drug | HSK7653 10 mg |
| HSK7653 25mg Q2WHSK7653 25mg (1 tablet) and placebo of HSK7653 5mg (2 tablets) Q2W, oral, Day1 to week12 | Drug | HSK7653 25 mg |
| PlaceboPlacebo of HSK7653 25mg (1 tablet) and placebo of HSK7653 5mg (2 tablets) Q2W, oral, Day1 to week12 | Drug | Placebo |
Primary outcome
Change From Baseline in Plasma Glucose AUC 0-3h for Meal Tolerance Test (MTT) at Week 12
Time frame: Baseline and Week 12
Plasma glucose AUC 0-3 hours for MTT was measured at Baseline (Week 0) and at Week 12. After fasting for ≥8 hours, blood samples for glucose measurement were drawn at 0 minutes (at standard meal loading), 30 minutes, 60 minutes, 90 minutes, 120 minutes, and 180 minutes. At Week 12, participants received study drug or placebo 50 minutes prior to consuming a standard meal.
10 secondary outcomes
Change From Baseline in Insulin AUC 0-3h for Meal Tolerance Test (MTT) at Week 12
Time frame: Baseline and Week 12
Change From Baseline in C-peptide AUC 0-3h for Meal Tolerance Test (MTT) at Week 12
Time frame: Baseline and Week 12
Change From Baseline in Fasting Glucose at Week 12
Time frame: Baseline and Week 12
Change From Baseline in Fasting Insulin at Week 12
Time frame: Baseline and Week 12
Change From Baseline in Fasting C-peptide at Week 12
Time frame: Baseline and Week 12
Change From Baseline in HOMA-IS at Week 12
Time frame: Baseline and Week 12
Change From Baseline in HOMA-β at Week 12
Time frame: Baseline and Week 12
Change From Baseline in Hemoglobin A1c (HbA1c) at Week 12
Time frame: Baseline and Week 12
Change From Baseline in Plasma Glucose Area Under the Curve 0 to 3 Hours (AUC 0-3 Hrs) for Oral Glucose Tolerance Test (OGTT) at Week 10
Time frame: Baseline and Week 10
Incidence of Treatment-Emergent Adverse Events
Time frame: Baseline and Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2024.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HSK7653 10mg Q2W and HSK7653 25mg Q2W in people with Impaired Glucose Tolerance, run by Haisco Pharmaceutical Group Co., Ltd. at 1 site in China.
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 2 inclusion and 14 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 25 Nov 2024. 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 China. 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. 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 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?
Change From Baseline in Plasma Glucose AUC 0-3h for Meal Tolerance Test (MTT) at Week 12 (time frame: Baseline and Week 12). 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 Nov 2024.