Type 2 DiabetesPhase 2NCT06703268
A Study on Switching From Daily DPP-4 Inhibitor to HSK7653 in Type 2 Diabetes Patients
A Phase 2 study testing HSK7653 10 mg and Daily DPP-4 inhibitor in people with Type 2 Diabetes, run by Haisco Pharmaceutical Group Co., Ltd. at 1 site in China.
Trial summary
To assess the effectiveness of HSK7653 tablets following the substitution of daily DPP-4 inhibitor (DPP-4i) over a 24-week treatment period. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- HSK7653 10 mg and Daily DPP-4 inhibitor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteChina
- Study dates
- 15 Jan 2024to 20 Nov 2024
- 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 ≤75 years
- T2DM patients,
- During the 12 weeks before screening, on the basis of diet control and exercise therapy, patients only regularly received daily DPP-4 inhibitors (such as sitagliptin, vildagliptin, saxagliptin, linagliptin, alogliptin and retagliptin , etc.) or combined with metformin (with a metformin dose of ≥ 1500 mg/day, or the maximum tolerated dose < 1500 mg/day but ≥ 1000 mg/day);
- HbA1c ≥6.5% and HbA1c <8.0%
- FPG <10.0 mmol/L
- BMI ≥19 and BMI ≤ 35 kg/m2 (Body Mass Index)
Who cannot join
- Non-type 2 diabetes: Type 1 diabetes, gestational diabetes or other special types of diabetes.
- The presence of any of the following medical histories or conditions at the time of screening:
- History of diabetic ketoacidosis or hyperglycemic hyperosmolar state within the recent 6 months;
- History of ≥2 episodes of severe hypoglycemia within the last 6 months;
- History of malignant tumors within the recent 5 years (except for cured basal cell carcinoma of the skin and cervical carcinoma in situ), or currently being evaluated for potential malignant tumors.
- Presence of severe mental disorders or language barriers, unwilling or unable to fully understand and cooperate.
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- History of drug abuse within the past 5 years
- Previous history or clinical evidence of acute or chronic pancreatitis.
- Using other drugs that may affect blood glucose metabolism within 12 weeks prior to screening, including systemic glucocorticoids (except for inhaled or topical ones), growth hormones, etc.
- Any laboratory test index meeting the following criteria:
- Hemoglobin < 110 g/L (for males) or < 100 g/L (for females).
- Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) > 3 times the upper limit of the normal value.
- Total bilirubin (TBIL) > 2 times the upper limit of the normal value.
- Fasting triglyceride (TG) > 5.7 mmol/L.
- Estimated glomerular filtration rate (eGFR) calculated using the CKD-EPI formula < 45 mL/min/1.73m².
- Known to be allergic to the investigational products or related excipients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Randomized, Open-label, Controlled Study on Evaluating the Efficacy and Safety of Switching From Daily DPP-4 Inhibitors to HSK7653 Tablets in Patients With Type 2 Diabetes Mellitus in China
To assess the effectiveness of HSK7653 tablets following the substitution of daily DPP-4 inhibitor (DPP-4i) over a 24-week treatment period.
- Conditions
- Type 2 Diabetes
- Being tested
- HSK7653 10 mg, Daily DPP-4 inhibitor
- Keywords
- HSK7653, DPP-4i
- 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
HSK7653 10 mg Q2W
Daily DPP-4 inhibitorDrug
Daily DPP-4 inhibitor
| Study group | Role | What they receive |
|---|---|---|
| HSK7653 | Experimental | HSK7653 10mg Q2W Receives: Drug: HSK7653 10 mg |
| Daily DPP-4 inhibitor | Active comparator | Daily DPP-4 inhibitor Receives: Drug: Daily DPP-4 inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time in range
The change in time in range (TIR) of continuous glucose monitoring (CGM) relative to the baseline after 24 weeks of treatment.
Measured: 24 weeks
Secondary outcomes (4)
HbA1c
Change from baseline in HbA1c after 24 weeks
Measured: 24 weeks
Fasting glucose
Change from baseline in fasting glucose after 24 weeks
Measured: 24 weeks
Mean glucose
Change from baseline in mean glucose after 24 weeks
Measured: 24 weeks
Treatment-emergent adverse events.
The incidence of treatment-emergent adverse events.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2024
- Study start15 Jan 2024
- Primary completion5 Oct 2024
- Study completion20 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies 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
- None (open label)
- Enrolment
- 64 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
- NCT06703268
- Sponsor's protocol ID
- HSK7653-203
- Status last verified
- Nov 2024
- First submitted
- 21 Nov 2024
- 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 Multicenter, Randomized, Open-label, Controlled Study on Evaluating the Efficacy and Safety of Switching From Daily DPP-4 Inhibitors to HSK7653 Tablets in Patients With Type 2 Diabetes Mellitus in China
- ClinicalTrials.gov ID
- NCT06703268
- Acronym / sponsor ID
- HSK7653-203
- Conditions
- Type 2 Diabetes
- Keywords
- HSK7653, DPP-4i
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Haisco Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 5 Oct 2024 (actual)
- Study completion
- 20 Nov 2024 (actual)
- First posted
- 25 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.
To assess the effectiveness of HSK7653 tablets following the substitution of daily DPP-4 inhibitor (DPP-4i) over a 24-week treatment period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HSK7653 | Experimental | Drug: HSK7653 10 mgHSK7653 10mg Q2W |
| Daily DPP-4 inhibitor | Active comparator | Drug: Daily DPP-4 inhibitorDaily DPP-4 inhibitor |
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 ≤75 years
- T2DM patients,
- During the 12 weeks before screening, on the basis of diet control and exercise therapy, patients only regularly received daily DPP-4 inhibitors (such as sitagliptin, vildagliptin, saxagliptin, linagliptin, alogliptin and retagliptin , etc.) or combined with metformin (with a metformin dose of ≥ 1500 mg/day, or the maximum tolerated dose < 1500 mg/day but ≥ 1000 mg/day);
- HbA1c ≥6.5% and HbA1c <8.0%
- FPG <10.0 mmol/L
Key exclusion criteria (16 listed)
- Non-type 2 diabetes: Type 1 diabetes, gestational diabetes or other special types of diabetes.
- The presence of any of the following medical histories or conditions at the time of screening:
- History of diabetic ketoacidosis or hyperglycemic hyperosmolar state within the recent 6 months;
- History of ≥2 episodes of severe hypoglycemia within the last 6 months;
- History of malignant tumors within the recent 5 years (except for cured basal cell carcinoma of the skin and cervical carcinoma in situ), or currently being evaluated for potential malignant tumors.
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 mgHSK7653 10 mg Q2W | Drug | HSK7653 |
| Daily DPP-4 inhibitorDaily DPP-4 inhibitor | Drug | Daily DPP-4 inhibitor |
Primary outcome
Time in range
Time frame: 24 weeks
The change in time in range (TIR) of continuous glucose monitoring (CGM) relative to the baseline after 24 weeks of treatment.
4 secondary outcomes
HbA1c
Time frame: 24 weeks
Fasting glucose
Time frame: 24 weeks
Mean glucose
Time frame: 24 weeks
Treatment-emergent adverse events.
Time frame: 24 weeks
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 10 mg and Daily DPP-4 inhibitor in people with Type 2 Diabetes, 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 16 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. 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?
Time in range (time frame: 24 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 25 Nov 2024.