Type 2 DiabetesPhase 3NCT07026968
A Study of Prusogliptin Tablets Combined With Dapagliflozin Tablets and Metformin Hydrochloride Extended Release Tablets in Type 2 Diabetes
A Phase 3 study of Type 2 Diabetes, run by CSPC Ouyi Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This study is a multicenter, randomized, double-blind, parallel-controlled, phase III clinical trial to evaluate efficacy and safety of the triple combination therapy of prusogliptin, dapagliflozin and metformin in subjects with type 2 diabetes who have inadequate glycemic control on metformin alone. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 2 Diabetes
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 815 participants
- Where
- 1 siteChina
- Study dates
- 20 Jun 2025to 13 Nov 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- Subjects with type 2 diabetes was confirmed at least 10 weeks prior to the screening;
- Male or female, 18 years ≤ age ≤ 75 years;
- Body Mass Index (BMI) ≥ 18.5 kg/m^2, and ≤40 kg/m^2;
- Stable metformin therapy for at least 10 weeks prior to screening at a dose ≥ 1500 mg per day;
- The glycated hemoglobin must meet the following standards:During screening: 7.5% ≤ HbA1c ≤ 11.0% (local laboratory);Before random sampling: 7.0% ≤ HbA1c ≤ 10.5% (central laboratory);
- Be able to understand and follow the test procedures, voluntarily participate in the test and sign the ICF.
Who cannot join
- Type 1 diabetes or other special types of diabetes;
- ≥2 episodes of Grade 3 hypoglycemia within 6 months prior to screening, or any Grade 3 hypoglycemia occurring from screening to randomization;
- ≥1 episode of acute diabetic complications (e.g., diabetic ketoacidosis, hyperglycemic hyperosmolar state) within 6 months prior to screening or prior to randomization;
- Severe chronic diabetic complications (e.g., proliferative diabetic retinopathy, severe diabetic neuropathy, diabetic foot) within 6 months prior to screening;
- History of acute or chronic pancreatitis at screening or prior to randomization;
- Inflammatory bowel disease, partial intestinal obstruction, or chronic intestinal diseases associated with malabsorption within 6 months prior to screening or prior to randomization;
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- Previous gastrointestinal surgeries that may cause malabsorption (excluding polypectomy and appendectomy), or chronic use of medications directly affecting gastrointestinal motility at screening or prior to randomization;
- Any cardiovascular event within 6 months prior to screening or prior to randomization, including: decompensated heart failure (NYHA Class III or IV); unstable angina, myocardial infarction, coronary artery bypass grafting, or coronary stent implantation; long QT syndrome or prolonged QTcF interval (male >450 ms, female >470 ms); clinically significant arrhythmia requiring treatment and deemed unsuitable for trial participation by the investigator;
- Hemorrhagic stroke or acute ischemic stroke within 6 months prior to screening or prior to randomization;
- Acute gallbladder disease within 6 months prior to screening, or active gallbladder disease requiring treatment at screening/prior to randomization;
- History of severe psychiatric disorders (e.g., depression, anxiety disorders), severe osteoporosis, or other medical conditions that may endanger participant safety as judged by the investigator;
- Malignancy (except clinically cured basal cell carcinoma or carcinoma in situ) diagnosed or treated within 5 years prior to screening or prior to randomization;
- Severe infection or trauma within 4 weeks prior to screening/prior to randomization; recurrent urinary tract infections or genital infections within 6 months prior to screening; or symptomatic urinary/genital infections at screening/prior to randomization;
- Clinically significant hematologic diseases (e.g., aplastic anemia, myelodysplastic syndrome) or conditions causing hemolysis or erythrocyte instability (e.g., malaria) at screening/prior to randomization;
- Pregnant or lactating women;
- Other conditions deemed unsuitable for trial participation by the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site
No. 896, Zhongshan East Road, High-tech Industrial Development Zone
Shijiazhuang, Hebei, 050035
About this study
Official title: A Multicenter, Randomized, Double-blind, Parallel-controlled, Phase III Clinical Trial to Evaluate the Efficacy and Safety of the Triple Combination Therapy of Prusogliptin , Dapagliflozin and Metformin in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Alone
This study is a multicenter, randomized, double-blind, parallel-controlled, phase III clinical trial to evaluate efficacy and safety of the triple combination therapy of prusogliptin, dapagliflozin and metformin in subjects with type 2 diabetes who have inadequate glycemic control on metformin alone.
Read the detailed description
Avoid duplicating information that will be entered elsewhere, such as Eligibility Criteria or Outcome Measures.
- Conditions
- Type 2 Diabetes
- Being tested
- Prusogliptin, Dapagliflozin(high dose), Dapagliflozin (low dose) placebo, plus metformin XR, Prusogliptin placebo, Dapagliflozin(high dose), Dapagliflozin (low dose) placebo, plus metformin XR, Prusogliptin, Dapagliflozin(high dose) placebo, Dapagliflozin (low dose), plus metformin XR, Prusogliptin placebo, Dapagliflozin (high dose) placebo, Dapagliflozin (low dose), plus metformin XR, Prusogliptin, Dapagliflozin (high dose) placebo, Dapagliflozin(low dose) placebo, plus metformin XR
- 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.
Prusogliptin, Dapagliflozin(high dose), Dapagliflozin (low dose) placebo, plus metformin XRDrug
Prusogliptin, Dapagliflozin(high dose) and Dapagliflozin (low dose) placebo, once a day, 1 tablet per dose; Metformin XR, Once a day, the dosage remains the same as the pre-screening dose.
Prusogliptin placebo, Dapagliflozin(high dose), Dapagliflozin (low dose) placebo, plus metformin XRDrug
Prusogliptin placebo, Dapagliflozin (high dose), Dapagliflozin (low dose) placebo, once a day, 1 tablet per dose; Metformin XR, Once a day, the dosage remains the same as the pre-screening dose
Prusogliptin, Dapagliflozin(high dose) placebo, Dapagliflozin (low dose), plus metformin XRDrug
Prusogliptin, Dapagliflozin (high dose) placebo, Dapagliflozin (low dose), once a day, 1 tablet per dose; Metformin XR, Once a day, the dosage remains the same as the pre-screening dose
Prusogliptin placebo, Dapagliflozin (high dose) placebo, Dapagliflozin (low dose), plus metformin XRDrug
Prusogliptin placebo, Dapagliflozin (high dose) placebo, Dapagliflozin (low dose), once a day, 1 tablet per dose; Metformin XR, Once a day, the dosage remains the same as the pre-screening dose
Prusogliptin, Dapagliflozin (high dose) placebo, Dapagliflozin(low dose) placebo, plus metformin XRDrug
Prusogliptin, Dapagliflozin (high dose) placebo, Dapagliflozin (low dose) placebo, once a day, 1 tablet per dose; Metformin XR, Once a day, the dosage remains the same as the pre-screening dose
| Study group | Role | What they receive |
|---|---|---|
| Prusogliptin, Dapagliflozin(high dose), plus metformin XR | Experimental | Not described Receives: Drug: Prusogliptin, Dapagliflozin(high dose), Dapagliflozin (low dose) placebo, plus metformin XR |
| Dapagliflozin(high dose), plus metformin XR | Active comparator | Not described Receives: Drug: Prusogliptin placebo, Dapagliflozin(high dose), Dapagliflozin (low dose) placebo, plus metformin XR |
| Prusogliptin, Dapagliflozin(low dose), plus metformin XR | Experimental | Not described Receives: Drug: Prusogliptin, Dapagliflozin(high dose) placebo, Dapagliflozin (low dose), plus metformin XR |
| Dapagliflozin(low dose), plus metformin XR | Active comparator | Not described Receives: Drug: Prusogliptin placebo, Dapagliflozin (high dose) placebo, Dapagliflozin (low dose), plus metformin XR |
| Prusogliptin, plus metformin XR | Active comparator | Not described Receives: Drug: Prusogliptin, Dapagliflozin (high dose) placebo, Dapagliflozin(low dose) placebo, plus metformin XR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change from baseline in HbA1c at Week 24
Measured: From baseline to week 24
Secondary outcomes (9)
Proportion of participants with HbA1c of ≤6.5% and HbA1c of ≤7% at week 24
Measured: From baseline to week 24
Relative change from baseline in HbA1c at week 12
Measured: From baseline to week 12
Relative change from baseline in FPG at week 12 and week 24
Measured: From baseline to week 12 and week 24
Relative change from baseline in 2h-PPG at week 12 and week 24
Measured: From baseline to week 12 and week 24
Relative change from baseline in weight at week 12 and week 24
Measured: From baseline to week 12 and week 24
Relative change from baseline in blood pressure at week 12 and week 24
Measured: From baseline to week 12 and week 24
Relative change from baseline in blood lipid level at week 12 and week 24
Measured: From baseline to week 12 and week 24
Relative change from baseline in 7-point blood glucose levels and average post-meal blood glucose increments at week 24
Measured: From baseline to week 24
Proportion of participants who received rescue treatment after 24 weeks of treatment
Measured: From baseline to week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2025
- Study start20 Jun 2025
- Primary completion30 Oct 2026 (estimated)
- Study completion13 Nov 2026 (estimated)
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 CSPC Ouyi Pharmaceutical 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicenter, Randomized, Double-blind, Parallel-controlled
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 815 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CSPC Ouyi Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07026968
- Sponsor's protocol ID
- HA1118-015
- Status last verified
- Jun 2025
- First submitted
- 10 Jun 2025
- Last updated
- 6 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Parallel-controlled, Phase III Clinical Trial to Evaluate the Efficacy and Safety of the Triple Combination Therapy of Prusogliptin , Dapagliflozin and Metformin in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Alone
- ClinicalTrials.gov ID
- NCT07026968
- Acronym / sponsor ID
- HA1118-015
- Conditions
- Type 2 Diabetes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 815 participants (estimated)
- Lead sponsor
- CSPC Ouyi Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 Jun 2025 (actual)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 13 Nov 2026 (estimated)
- First posted
- 18 Jun 2025 (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 a multicenter, randomized, double-blind, parallel-controlled, phase III clinical trial to evaluate efficacy and safety of the triple combination therapy of prusogliptin, dapagliflozin and metformin in subjects with type 2 diabetes who have inadequate glycemic control on metformin alone.
Detailed description
Avoid duplicating information that will be entered elsewhere, such as Eligibility Criteria or Outcome Measures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
- Model description
- Multicenter, Randomized, Double-blind, Parallel-controlled
| Arm | Type | Receives |
|---|---|---|
| Prusogliptin, Dapagliflozin(high dose), plus metformin XR | Experimental | Drug: Prusogliptin, Dapagliflozin(high dose), Dapagliflozin (low dose) placebo, plus metformin XR |
| Dapagliflozin(high dose), plus metformin XR | Active comparator | Drug: Prusogliptin placebo, Dapagliflozin(high dose), Dapagliflozin (low dose) placebo, plus metformin XR |
| Prusogliptin, Dapagliflozin(low dose), plus metformin XR | Experimental | Drug: Prusogliptin, Dapagliflozin(high dose) placebo, Dapagliflozin (low dose), plus metformin XR |
| Dapagliflozin(low dose), plus metformin XR | Active comparator | Drug: Prusogliptin placebo, Dapagliflozin (high dose) placebo, Dapagliflozin (low dose), plus metformin XR |
| Prusogliptin, plus metformin XR | Active comparator | Drug: Prusogliptin, Dapagliflozin (high dose) placebo, Dapagliflozin(low dose) placebo, plus metformin XR |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects with type 2 diabetes was confirmed at least 10 weeks prior to the screening;
- Male or female, 18 years ≤ age ≤ 75 years;
- Body Mass Index (BMI) ≥ 18.5 kg/m^2, and ≤40 kg/m^2;
- Stable metformin therapy for at least 10 weeks prior to screening at a dose ≥ 1500 mg per day;
- The glycated hemoglobin must meet the following standards:During screening: 7.5% ≤ HbA1c ≤ 11.0% (local laboratory);Before random sampling: 7.0% ≤ HbA1c ≤ 10.5% (central laboratory);
Key exclusion criteria (16 listed)
- Type 1 diabetes or other special types of diabetes;
- ≥2 episodes of Grade 3 hypoglycemia within 6 months prior to screening, or any Grade 3 hypoglycemia occurring from screening to randomization;
- ≥1 episode of acute diabetic complications (e.g., diabetic ketoacidosis, hyperglycemic hyperosmolar state) within 6 months prior to screening or prior to randomization;
- Severe chronic diabetic complications (e.g., proliferative diabetic retinopathy, severe diabetic neuropathy, diabetic foot) within 6 months prior to screening;
- History of acute or chronic pancreatitis at screening or prior to randomization;
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 |
|---|---|---|
| Prusogliptin, Dapagliflozin(high dose), Dapagliflozin (low dose) placebo, plus metformin XRPrusogliptin, Dapagliflozin(high dose) and Dapagliflozin (low dose) placebo, once a day, 1 tablet per dose; Metformin XR, Once a day, the dosage remains the same as the pre-screening dose. | Drug | Prusogliptin, Dapagliflozin(high dose), plus metformin XR |
| Prusogliptin placebo, Dapagliflozin(high dose), Dapagliflozin (low dose) placebo, plus metformin XRPrusogliptin placebo, Dapagliflozin (high dose), Dapagliflozin (low dose) placebo, once a day, 1 tablet per dose; Metformin XR, Once a day, the dosage remains the same as the pre-screening dose | Drug | Dapagliflozin(high dose), plus metformin XR |
| Prusogliptin, Dapagliflozin(high dose) placebo, Dapagliflozin (low dose), plus metformin XRPrusogliptin, Dapagliflozin (high dose) placebo, Dapagliflozin (low dose), once a day, 1 tablet per dose; Metformin XR, Once a day, the dosage remains the same as the pre-screening dose | Drug | Prusogliptin, Dapagliflozin(low dose), plus metformin XR |
| Prusogliptin placebo, Dapagliflozin (high dose) placebo, Dapagliflozin (low dose), plus metformin XRPrusogliptin placebo, Dapagliflozin (high dose) placebo, Dapagliflozin (low dose), once a day, 1 tablet per dose; Metformin XR, Once a day, the dosage remains the same as the pre-screening dose | Drug | Dapagliflozin(low dose), plus metformin XR |
| Prusogliptin, Dapagliflozin (high dose) placebo, Dapagliflozin(low dose) placebo, plus metformin XRPrusogliptin, Dapagliflozin (high dose) placebo, Dapagliflozin (low dose) placebo, once a day, 1 tablet per dose; Metformin XR, Once a day, the dosage remains the same as the pre-screening dose | Drug | Prusogliptin, plus metformin XR |
Primary outcome
Mean change from baseline in HbA1c at Week 24
Time frame: From baseline to week 24
9 secondary outcomes
Proportion of participants with HbA1c of ≤6.5% and HbA1c of ≤7% at week 24
Time frame: From baseline to week 24
Relative change from baseline in HbA1c at week 12
Time frame: From baseline to week 12
Relative change from baseline in FPG at week 12 and week 24
Time frame: From baseline to week 12 and week 24
Relative change from baseline in 2h-PPG at week 12 and week 24
Time frame: From baseline to week 12 and week 24
Relative change from baseline in weight at week 12 and week 24
Time frame: From baseline to week 12 and week 24
Relative change from baseline in blood pressure at week 12 and week 24
Time frame: From baseline to week 12 and week 24
Relative change from baseline in blood lipid level at week 12 and week 24
Time frame: From baseline to week 12 and week 24
Relative change from baseline in 7-point blood glucose levels and average post-meal blood glucose increments at week 24
Time frame: From baseline to week 24
Proportion of participants who received rescue treatment after 24 weeks of treatment
Time frame: From baseline to week 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
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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 3 study of Type 2 Diabetes, run by CSPC Ouyi Pharmaceutical 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: under way, not looking for participants, as of the sponsor's last update on 6 Apr 2026. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Mean change from baseline in HbA1c at Week 24 (time frame: From baseline to week 24). 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 6 Apr 2026.