Type 2 Diabetes MellitusPhase 2NCT07755150
A Study to Evaluate the Efficacy and Safety of DA-302168S Tablets in Subjects With Type 2 Diabetes
A Phase 2 study testing DA-302168S in people with Type 2 Diabetes Mellitus, run by Chendu DIAO Pharmaceutical Group CO., LTD. at 1 site in China.
Trial summary
This Phase II, multicenter, randomized, double-blind, placebo-controlled, parallel-group study aims to assess the efficacy, safety, and PK characteristics of DA-302168S tablets in Chinese T2DM participants, and to provide dose-selection evidence for the Phase III confirmatory trial. 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?
- DA-302168S
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 272 participants
- Where
- 1 siteChina
- Study dates
- 30 Aug 2026to 20 Oct 2027
- Phase
- Phase 2
- 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
- Age 18 to 75 years (inclusive), both sexes.
- Diagnosed with T2DM according to the Chinese Diabetes Prevention and Treatment Guidelines (2024 Edition) for at least 3 months at screening, and meeting one of the following: (1) on stable metformin monotherapy for ≥8 weeks prior to screening, with a daily dose of ≥1500 mg/day or maximum tolerated dose ≥1000 mg/day, in addition to diet and exercise; stable treatment defined as no change in daily dose; (2) glycemic control by diet and exercise alone for ≥8 weeks prior to screening.
- HbA1c (local laboratory) ≥7.5% and ≤11.0% at screening; and HbA1c (central laboratory) ≥7.5% and ≤10.5% at randomization.
- BMI 22.5-40 kg/m² (inclusive), and stable body weight for 3 months prior to screening (weight change <5%, calculated as [max weight - min weight] / max weight × 100%).
Who cannot join
- History of type 1 diabetes, diabetes due to pancreatic injury, or other types of diabetes (excluding gestational diabetes) other than T2DM.
- Acute diabetic complications (e.g., diabetic ketoacidosis, lactic acidosis, or hyperosmolar nonketotic coma) within 6 months prior to ICF signing; history of grade 3 hypoglycemia within 6 months prior to ICF signing, or ≥3 episodes of hypoglycemia (blood glucose <3.9 mmol/L) from 1 month before screening to randomization.
- Clinically significant active infection or other diseases (including but not limited to neurological, psychiatric, cardiovascular, endocrine, digestive, respiratory, urinary, hematological, or immunological disorders, except those related to T2DM) within 6 months prior to screening that, in the investigator's judgment, may interfere with trial results or pose additional risks with study drug administration.
- Endocrine diseases or history that may significantly affect body weight (e.g., Cushing's syndrome, obesity due to pituitary or hypothalamic disorders), or obesity due to monogenic mutations or genetic obesity syndromes.
- Evidence of significant active autoimmune abnormalities (e.g., lupus or rheumatoid arthritis) requiring systemic glucocorticoid therapy during the trial, as judged by the investigator.
- Severe chronic diabetic complications at screening (e.g., proliferative retinopathy or maculopathy, painful diabetic neuropathy, intermittent claudication, or diabetic foot).
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- History or family history of medullary thyroid carcinoma, thyroid C-cell hyperplasia, or multiple endocrine neoplasia type 2.
- Hyperthyroidism (including clinical and subclinical) at screening, or hypothyroidism not controlled with stable medication dose (defined as stable dose for ≥3 months with normal thyroid function tests) based on local laboratory reference ranges.
- History of acute pancreatitis, or prior chronic pancreatitis or pancreatic injury, or other high-risk factors for pancreatitis.
- Acute cholecystitis within 3 months prior to ICF signing, or presence of cholecystitis/cholangitis/bile duct stones/multiple gallstones at screening, or gallbladder-related conditions at screening that, in the investigator's judgment, may predispose to cholecystitis (except those who have undergone cholecystectomy and are deemed eligible by the investigator).
- Dysphagia or history of gastrointestinal disorders affecting drug absorption, including but not limited to gastrectomy or resection of any intestinal segment, severe gastrointestinal disease, or clinically evident gastric emptying abnormalities.
- Uncontrolled or unstable hypertension at screening, defined as SBP ≥160 mmHg and/or DBP ≥100 mmHg despite regular antihypertensive treatment, or evidence of renal artery stenosis or unstable blood pressure (including orthostatic hypotension).
- Clinically significant cardiovascular or cerebrovascular diseases, including but not limited to the following events within 6 months prior to ICF signing or during the run-in period: a. unstable angina; b. heart failure (NYHA class III or IV); c. myocardial infarction; d. coronary artery bypass grafting or percutaneous coronary intervention; e. uncontrolled severe arrhythmias, such as sick sinus syndrome, second- or third-degree atrioventricular block; f. cerebrovascular accidents, such as cerebral infarction or transient ischemic attack.
- Hemoglobinopathies or anemia, such as hemolytic anemia or sickle cell anemia.
- History of moderate or severe depression, or PHQ-9 score ≥15 at screening (see Appendix 2), or psychiatric disorders that, in the investigator's opinion, may affect participation.
- Electrocardiogram abnormalities during screening or run-in: heart rate <50 bpm or >100 bpm; QTcF (Fridericia-corrected) >450 ms (male) or >470 ms (female).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Peking University People's Hospital
Beijing
linong ji, 13910978815, jiln@bjmu.edu.cn
About this study
Official title: A Multicenter, Randomized, Double-blind, Parallel, Placebo-controlled Phase II Study Assessing the Efficacy and Safety of DA-302168S Tablets in Subjects With Type 2 Diabetes Mellitus.
This Phase II, multicenter, randomized, double-blind, placebo-controlled, parallel-group study aims to assess the efficacy, safety, and PK characteristics of DA-302168S tablets in Chinese T2DM participants, and to provide dose-selection evidence for the Phase III confirmatory trial.
Read the detailed description
This Phase II study is designed to enroll approximately 272 adult participants with T2DM. A total of 260 participants will be randomized in a 1:1:1:1:1 ratio to receive DA-302168S at 5 mg, 10 mg, 15 mg, or 20 mg, or matching placebo. An additional open-label cohort (Cohort 5) will enroll 12 participants, all treated with the investigational product at the target dose of 20 mg. The study comprises a screening period of up to 2 weeks, a 4-week run-in period, a 16-week treatment phase, and a 2-week safety follow-up.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- DA-302168S, Placebo of DA-302168S
- 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.
DA-302168SDrug
A small molecule GLP-1R agonist tablet, orally administration, once daily，16weeks.
Placebo of DA-302168SDrug
Matching placebo tablet will be provided
| Study group | Role | What they receive |
|---|---|---|
| DA-302168S | Experimental | Cohort 1-5mg dose group：Participants will receive DA-302168S tablets once daily orally, 16weeks.
Cohort 2-10mg dose group：Participants will receive DA-302168S tablets once daily orally, 16weeks.
Cohort 3-15mg dose group：Participants will receive DA-302168S tablets once daily orally, 16weeks.
Cohort 4-20mg dose group：Participants will receive DA-302168S tablets once daily orally, 16weeks.
Cohort 5-20mg dose group：Participants will receive DA-302168S tablets once daily orally, 10weeks. Receives: Drug: DA-302168S |
| Placebo of DA-302168S | Placebo comparator | Cohort 1-5mg dose group：Participants will receive matching placebo tablets orally once daily for 16 weeks.
Cohort 2-10mg dose group：Participants will receive matching placebo tablets orally once daily for 16 weeks.
Cohort 3-15mg dose group：Participants will receive matching placebo tablets orally once daily for 16 weeks.
Cohort 4-20mg dose group：Participants will receive matching placebo tablets orally once daily for 16 weeks. Receives: Drug: Placebo of DA-302168S |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in HbA1c
measured in %
Measured: From baseline (week 1) to week 16
Secondary outcomes (9)
Percentage of participants with HbA1c <7.0% and ≤6.5%
percentage-point
Measured: From baseline (week 1) to week 16
Change from baseline in fasting blood glucose
Measured: From baseline (week 1) to week 16
Change from baseline in fasting lipid profile
Measured: From baseline (week 1) to week 16
Change from baseline in systolic and diastolic blood pressure
Measured: From baseline (week 1) to week 16
Percent changes from baseline in body weight
Measured: From baseline (week 1) to week 16
Adverse events, including treatment-emergent adverse events (TEAEs), serious adverse events (SAEs)
Measured: From baseline (week 1) to week 18
Change from baseline in fasting C-peptide
Measured: From baseline (week 1) to week 16
Change from baseline in fasting insulin
Measured: From baseline (week 1) to week 16
Change from baseline in fasting glucagon
Measured: From baseline (week 1) to week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2026
- Study start30 Aug 2026 (estimated)
- Primary completion20 Oct 2027 (estimated)
- Study completion20 Oct 2027 (estimated)
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.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 272 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chendu DIAO Pharmaceutical Group CO., LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07755150
- Sponsor's protocol ID
- 2025-CP-DA168-08
- Status last verified
- Aug 2026
- First submitted
- 5 Aug 2026
- Last updated
- 31 Aug 2026
- 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 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Parallel, Placebo-controlled Phase II Study Assessing the Efficacy and Safety of DA-302168S Tablets in Subjects With Type 2 Diabetes Mellitus.
- ClinicalTrials.gov ID
- NCT07755150
- Acronym / sponsor ID
- 2025-CP-DA168-08
- Conditions
- Type 2 Diabetes Mellitus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 272 participants (estimated)
- Lead sponsor
- Chendu DIAO Pharmaceutical Group CO., LTD.Industry (pharma, biotech, devices)
- Study start
- 30 Aug 2026 (estimated)
- Primary completion
- 20 Oct 2027 (estimated)
- Study completion
- 20 Oct 2027 (estimated)
- First posted
- 10 Aug 2026 (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 Phase II, multicenter, randomized, double-blind, placebo-controlled, parallel-group study aims to assess the efficacy, safety, and PK characteristics of DA-302168S tablets in Chinese T2DM participants, and to provide dose-selection evidence for the Phase III confirmatory trial.
Detailed description
This Phase II study is designed to enroll approximately 272 adult participants with T2DM. A total of 260 participants will be randomized in a 1:1:1:1:1 ratio to receive DA-302168S at 5 mg, 10 mg, 15 mg, or 20 mg, or matching placebo. An additional open-label cohort (Cohort 5) will enroll 12 participants, all treated with the investigational product at the target dose of 20 mg. The study comprises a screening period of up to 2 weeks, a 4-week run-in period, a 16-week treatment phase, and a 2-week safety follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DA-302168S | Experimental | Drug: DA-302168SCohort 1-5mg dose group：Participants will receive DA-302168S tablets once daily orally, 16weeks. Cohort 2-10mg dose group：Participants will receive DA-302168S tablets once daily orally, 16weeks. Cohort 3-15mg dose group：Participants will receive DA-302168S tablets once daily orally, 16weeks. Cohort 4-20mg dose group：Participants will receive DA-302168S tablets once daily orally, 16weeks. Cohort 5-20mg dose group：Participants will receive DA-302168S tablets once daily orally, 10weeks. |
| Placebo of DA-302168S | Placebo comparator | Drug: Placebo of DA-302168SCohort 1-5mg dose group：Participants will receive matching placebo tablets orally once daily for 16 weeks. Cohort 2-10mg dose group：Participants will receive matching placebo tablets orally once daily for 16 weeks. Cohort 3-15mg dose group：Participants will receive matching placebo tablets orally once daily for 16 weeks. Cohort 4-20mg dose group：Participants will receive matching placebo tablets orally once daily for 16 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 to 75 years (inclusive), both sexes.
- Diagnosed with T2DM according to the Chinese Diabetes Prevention and Treatment Guidelines (2024 Edition) for at least 3 months at screening, and meeting one of the following: (1) on stable metformin monotherapy for ≥8 weeks prior to screening, with a daily dose of ≥1500 mg/day or maximum tolerated dose ≥1000 mg/day, in addition to diet and exercise; stable treatment defined as no change in daily dose; (2) glycemic control by diet and exercise alone for ≥8 weeks prior to screening.
- HbA1c (local laboratory) ≥7.5% and ≤11.0% at screening; and HbA1c (central laboratory) ≥7.5% and ≤10.5% at randomization.
- BMI 22.5-40 kg/m² (inclusive), and stable body weight for 3 months prior to screening (weight change <5%, calculated as [max weight - min weight] / max weight × 100%).
Key exclusion criteria (16 listed)
- History of type 1 diabetes, diabetes due to pancreatic injury, or other types of diabetes (excluding gestational diabetes) other than T2DM.
- Acute diabetic complications (e.g., diabetic ketoacidosis, lactic acidosis, or hyperosmolar nonketotic coma) within 6 months prior to ICF signing; history of grade 3 hypoglycemia within 6 months prior to ICF signing, or ≥3 episodes of hypoglycemia (blood glucose <3.9 mmol/L) from 1 month before screening to randomization.
- Clinically significant active infection or other diseases (including but not limited to neurological, psychiatric, cardiovascular, endocrine, digestive, respiratory, urinary, hematological, or immunological disorders, except those related to T2DM) within 6 months prior to screening that, in the investigator's judgment, may interfere with trial results or pose additional risks with study drug administration.
- Endocrine diseases or history that may significantly affect body weight (e.g., Cushing's syndrome, obesity due to pituitary or hypothalamic disorders), or obesity due to monogenic mutations or genetic obesity syndromes.
- Evidence of significant active autoimmune abnormalities (e.g., lupus or rheumatoid arthritis) requiring systemic glucocorticoid therapy during the trial, as judged by the investigator.
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 |
|---|---|---|
| DA-302168SA small molecule GLP-1R agonist tablet, orally administration, once daily，16weeks. | Drug | DA-302168S |
| Placebo of DA-302168SMatching placebo tablet will be provided | Drug | Placebo of DA-302168S |
Primary outcome
Change from baseline in HbA1c
Time frame: From baseline (week 1) to week 16
measured in %
9 secondary outcomes
Percentage of participants with HbA1c <7.0% and ≤6.5%
Time frame: From baseline (week 1) to week 16
Change from baseline in fasting blood glucose
Time frame: From baseline (week 1) to week 16
Change from baseline in fasting lipid profile
Time frame: From baseline (week 1) to week 16
Change from baseline in systolic and diastolic blood pressure
Time frame: From baseline (week 1) to week 16
Percent changes from baseline in body weight
Time frame: From baseline (week 1) to week 16
Adverse events, including treatment-emergent adverse events (TEAEs), serious adverse events (SAEs)
Time frame: From baseline (week 1) to week 18
Change from baseline in fasting C-peptide
Time frame: From baseline (week 1) to week 16
Change from baseline in fasting insulin
Time frame: From baseline (week 1) to week 16
Change from baseline in fasting glucagon
Time frame: From baseline (week 1) to week 16
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 31 Aug 2026.
- 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.
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 DA-302168S in people with Type 2 Diabetes Mellitus, run by Chendu DIAO 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 4 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: opening soon, as of the sponsor's last update on 31 Aug 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. 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?
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?
Contact xiaolong qin (+8618781997925, qinxiaolong.cn@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in HbA1c (time frame: From baseline (week 1) to week 16). 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 31 Aug 2026.