Type 2 Diabetes
Conditions
Brief summary
The aim of this trial is to evaluate the efficacy and safety of HRS-7535 in subjects with type 2 diabetes mellitus.
Interventions
DRUGHRS-7535
HRS-7535
DRUGPlacebo
Placebo
Sponsors
Shandong Suncadia Medicine Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Intervention model description
HRS-7535 tablet compared with placebo
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Male or female, 18-75 age years, both inclusive; 2. Type 2 diabetes mellitus diagnosed for at least 3 months before the screening visit; 3. HbA1c 7.5-11.0% (both inclusive) by local laboratory analysis; 4. Treated with conventional lifestyle intervention and stable treatment with metformin (≥1000 mg/day) at least 8 weeks prior to screening. 5. Body weight of at least 50 kg; and Body Mass Index (BMI) within the range of 19 to 40 kg/m2 (inclusive);
Exclusion criteria
1. Known or suspected allergy to the investigational drug or its components or excipients. 2. Diagnosed or suspected with type 1 diabetes mellitus, special types of diabetes or secondary diabetes. 3. Have a history of acute complications of diabetes (diabetic ketoacidosis, lactic acidosis, hyperglycaemic hyperosmolar state, etc.) within 6 months prior to screening. 4. Proliferative retinopathy, maculopathy, painful diabetic neuropathy, diabetic foot ulcer or intermittent claudication requiring acute treatment; 5. History or presence of vital organ primary diseases, including but not limited to neuropsychiatric, cardiovascular, digestive, respiratory, urinary, endocrine, blood, immune and other diseases, judged by researchers to be unsuitable for this study. 6. Discontinuation of previous glucagon-like peptide-1 receptor agonist therapy due to safety/tolerability reasons or lack of efficacy reasons. 7. Previous history of significant gastrointestinal disease (e.g. gastroesophageal reflux, gastric outlet obstruction, inflammatory bowel disease, active ulcers, etc.), or previous gastrointestinal surgery (except gastrointestinal polypectomy and appendectomy). 8. Pregnancy, breast-feeding, intention of becoming pregnant during the trial; or women of childbearing potential (WOCBP) or male subject not using adequate contraceptive measures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean Change From Baseline in HbA1c at Week 16 | at Week 16] |
Secondary
| Measure | Time frame |
|---|---|
| Change From Baseline in fasting plasma glucose (FPG) at Week 16 | at Week 16 |
| Change From Baseline in Mixed meal test at Week 16 | at Week 16 |
| Change From Baseline in body weight at Week 16 | at Week 16 |
| Proportion of subjects reaching HbA1c targets (<7.0%) at Week 16 | at Week 16 |
| Change From Baseline in 7-point SMBG at Week 16 | at Week 16 |
| Proportion of subjects receiving glycemic rescue medicine at Week 16 | at Week 16 |
| A summary of adverse events, including serious adverse events (SAEs), and Hypoglycemic Event[ | at Week 18 |
| Change From Baseline in waist circumference at Week 16 | at Week 16 |
Contacts
Primary ContactYimei Xu
Backup ContactShujin Cheng
Outcome results
None listed