Type 2 Diabetes MellitusPhase 2NCT06059326
Multiple-dose Study to Evaluate the Safety,Tolerability, Pharmacokinetics and Pharmacodynamics of HSK7653 in T2DM
A Phase 2 study testing HSK7653 10 mg, HSK7653 25 mg and HSK7653 50 mg in people with Type 2 Diabetes Mellitus, run by Haisco Pharmaceutical Group Co., Ltd. at 1 site in China.
Trial summary
To evaluate the safety, tolerability and pharmacokinetic (PK)/pharmacodynamic (PD) characteristics of HSK7653 tablets in Type 2 Diabetes Mellitus Patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- HSK7653 10 mg, HSK7653 25 mg and HSK7653 50 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- 22 Jan 2019to 5 Nov 2019
- 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
- Age ≥18 and Age ≤70 years
- T2DM patients,
- Control the blood glucose level only with diet and exercise in last 3 months;
- BMI ≥19 and BMI ≤ 35 kg/m2 (Body Mass Index)
- HbA1c ≥7.0% and HbA1c <10.0%
- FPG <13.9 mmol/L
Who cannot join
- Non-type 2 diabetes mellitus: Type 1 diabetes mellitus, gestational diabetes history;
- History of acute complications of diabetes (diabetic ketoacidosis, diabetic hyperglycemia hyperosmolar syndrome or lactic acidosis);
- History of chronic complications of severe diabetes (retinal proliferative disease, severe diabetic neuropathy or intermittent claudication confirmed by fundus examination during screening);
- Patients who used systemic glucocorticoids within 3 months prior to screening had severe infections or major surgeries and transplants within 3 months;
- Three or more episodes of hypoglycemia occurred in the six months prior to screening;
- History of hyperthyroidism within 6 months before screening;
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- Severe cardiovascular disease. ;
- Medical conditions that may significantly affect drug absorption, distribution, metabolism, and excretion within 2 weeks prior to screening;
- Liver function tests abnormal;
- Moderate or severe renal impairment;
- Medical history or clinical evidence of pancreatic injury or pancreatitis, or abnormalities in lipase and amylase judged by investigators to be clinically significant;
- Patients with a history of hypertension who regularly take antihypertensive therapy for over 4 weeks still have poor control, SBP > 160 mmHg and (or) DBP > 100 mmHg;
- Patients with uncontrolled hyperlipidemia.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking university people's hospital
Beijing, Beijing Municipality, 100044
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo Control, Dose-escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HSK7653 in Type 2 Diabetes Mellitus Patients
To evaluate the safety, tolerability and pharmacokinetic (PK)/pharmacodynamic (PD) characteristics of HSK7653 tablets in Type 2 Diabetes Mellitus Patients.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- HSK7653 10 mg, HSK7653 25 mg, HSK7653 50 mg, 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.
HSK7653 10 mgDrug
Tablet, HSK7653 10 mg Q2W, 12 weeks
HSK7653 25 mgDrug
Tablet, HSK7653 25 mg Q2W, 12 weeks
HSK7653 50 mgDrug
Tablet, HSK7653 50 mg Q2W, 12 weeks
PlaceboDrug
Tablet, 0 mg Q2W, 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| HSK7653 10 mg | Experimental | Not described Receives: Drug: HSK7653 10 mg |
| HSK7653 25 mg | Experimental | Not described Receives: Drug: HSK7653 25 mg |
| HSK7653 50 mg | Experimental | Not described Receives: Drug: HSK7653 50 mg |
| 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.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Assessment by adverse event monitoring, 12 lead ECGs, vital signs and laboratory measurements.
Measured: From baseline to up to 2 weeks after last dose for a total of approximately 14 weeks
Secondary outcomes (7)
Peak plasma concentration (Cmax) of HSK7653
Cmax of HSK7653 after first dose and multi-dose administration
Measured: Day 1 to Day 43
Area under the plasma concentration versus time curve (AUC) of HSK7653
AUC of HSK7653 after first dose and multi-dose administration
Measured: Day 1 to Day 43
Half-life (t1/2) of HSK7653
T1/2 of HSK7653 after single-dose and multi-dose administration
Measured: Day 1 to Day 43
Change from baseline in dipeptidyl peptidase-IV (DPP-4) inhibition rate
Change from baseline in dipeptidyl peptidase-IV (DPP-4) inhibition rate after single-dose and multi-dose administration of HSK7653
Measured: Day 1 to Day 84
Change from baseline in GLP-1
Change from baseline in GLP-1 after single-dose and multi-dose administration of HSK7653
Measured: Day 1 to Day 84
Change from baseline of fasting plasma glucose
Change from baseline in fasting plasma glucose after multi-dose administration of HSK7653
Measured: Day 1 to Day 84
Change from baseline of HbA1c
Change from baseline in HbA1c after multi-dose administration of HSK7653
Measured: Day 1 to Day 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start22 Jan 2019
- Primary completion5 Nov 2019
- Study completion5 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies 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
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 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
- NCT06059326
- Sponsor's protocol ID
- HSK7653-201
- Status last verified
- Sep 2023
- First submitted
- 23 Sep 2023
- Last updated
- 28 Sep 2023
- 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 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo Control, Dose-escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HSK7653 in Type 2 Diabetes Mellitus Patients
- ClinicalTrials.gov ID
- NCT06059326
- Acronym / sponsor ID
- HSK7653-201
- Conditions
- Type 2 Diabetes Mellitus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Haisco Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 22 Jan 2019 (actual)
- Primary completion
- 5 Nov 2019 (actual)
- Study completion
- 5 Nov 2019 (actual)
- First posted
- 28 Sep 2023 (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.
To evaluate the safety, tolerability and pharmacokinetic (PK)/pharmacodynamic (PD) characteristics of HSK7653 tablets in Type 2 Diabetes Mellitus Patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| HSK7653 10 mg | Experimental | Drug: HSK7653 10 mg |
| HSK7653 25 mg | Experimental | Drug: HSK7653 25 mg |
| HSK7653 50 mg | Experimental | Drug: HSK7653 50 mg |
| 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 (6 listed)
- Age ≥18 and Age ≤70 years
- T2DM patients,
- Control the blood glucose level only with diet and exercise in last 3 months;
- BMI ≥19 and BMI ≤ 35 kg/m2 (Body Mass Index)
- HbA1c ≥7.0% and HbA1c <10.0%
Key exclusion criteria (13 listed)
- Non-type 2 diabetes mellitus: Type 1 diabetes mellitus, gestational diabetes history;
- History of acute complications of diabetes (diabetic ketoacidosis, diabetic hyperglycemia hyperosmolar syndrome or lactic acidosis);
- History of chronic complications of severe diabetes (retinal proliferative disease, severe diabetic neuropathy or intermittent claudication confirmed by fundus examination during screening);
- Patients who used systemic glucocorticoids within 3 months prior to screening had severe infections or major surgeries and transplants within 3 months;
- Three or more episodes of hypoglycemia occurred in the six months prior to screening;
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 10 mgTablet, HSK7653 10 mg Q2W, 12 weeks | Drug | HSK7653 10 mg |
| HSK7653 25 mgTablet, HSK7653 25 mg Q2W, 12 weeks | Drug | HSK7653 25 mg |
| HSK7653 50 mgTablet, HSK7653 50 mg Q2W, 12 weeks | Drug | HSK7653 50 mg |
| PlaceboTablet, 0 mg Q2W, 12 weeks | Drug | Placebo |
Primary outcome
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time frame: From baseline to up to 2 weeks after last dose for a total of approximately 14 weeks
Assessment by adverse event monitoring, 12 lead ECGs, vital signs and laboratory measurements.
7 secondary outcomes
Peak plasma concentration (Cmax) of HSK7653
Time frame: Day 1 to Day 43
Area under the plasma concentration versus time curve (AUC) of HSK7653
Time frame: Day 1 to Day 43
Half-life (t1/2) of HSK7653
Time frame: Day 1 to Day 43
Change from baseline in dipeptidyl peptidase-IV (DPP-4) inhibition rate
Time frame: Day 1 to Day 84
Change from baseline in GLP-1
Time frame: Day 1 to Day 84
Change from baseline of fasting plasma glucose
Time frame: Day 1 to Day 84
Change from baseline of HbA1c
Time frame: Day 1 to Day 84
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 28 Sep 2023.
- 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 10 mg, HSK7653 25 mg and HSK7653 50 mg in people with Type 2 Diabetes Mellitus, 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 6 inclusion and 13 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 28 Sep 2023. 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?
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) (time frame: From baseline to up to 2 weeks after last dose for a total of approximately 14 weeks). 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 28 Sep 2023; AzTrials last refreshed its copy on 30 Oct 2026.