A Study to Evaluate the Efficacy and Safety of DA-302168S Tablets in Subjects With Type 2 Diabetes (NCT07755150) | Clinical Trial Compass
Not Yet RecruitingPhase 2
A Study to Evaluate the Efficacy and Safety of DA-302168S Tablets in Subjects With Type 2 Diabetes
China272 participantsStarted 2026-08-30
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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%).
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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).
. 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.