Actively Recruiting
Study to Evaluate HDM1002 Tablets in Adults With Type 2 Diabetes Mellitus
Led by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. · Updated on 2025-09-25
360
Participants Needed
1
Research Sites
76 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study, which aims to provide data on the efficacy and safety of HDM1002 tablets in adults with type 2 diabetes mellitus (T2DM) inadequately controlled with diet and exercise only
CONDITIONS
Official Title
Study to Evaluate HDM1002 Tablets in Adults With Type 2 Diabetes Mellitus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 to 75 years inclusive
- Diagnosed with type 2 diabetes mellitus for at least 10 weeks
- Treated with diet and exercise only for at least 10 weeks before signing consent
- Not treated with any hypoglycemic drugs in the 10 weeks before signing consent
- HbA1c between 7.5% and 10.5% at screening and before randomization
- Body mass index (BMI) between 22.5 and 40.0 kg/m2 inclusive
- Agree to use highly effective contraception from consent signing until 30 days (female) or 90 days (male) after final dose
- Able to understand and comply with protocol, maintain diet and exercise habits, and provide informed consent
You will not qualify if you...
- Diagnosed with type 1 diabetes, special types of diabetes, or gestational diabetes
- Had acute diabetes complications in past 6 months (e.g., ketoacidosis, lactosidosis, coma)
- Known personal or family history of medullary thyroid carcinoma, thyroid C-cell hyperplasia, or MEN2
- History of pancreatitis, pancreatic injury, or symptomatic gallbladder disease needing treatment during trial
- Conditions affecting gastric emptying or nutrient absorption (e.g., surgery, reflux disease, bowel syndrome)
- Had unstable angina, severe heart failure, heart attack, heart surgery, severe arrhythmias, or stroke within 3 months before screening
- History of severe diabetic eye disease requiring treatment
- Known liver disease including active hepatitis B or C or primary biliary cholangitis
- Used certain enzyme inhibitors or inducers or narrow therapeutic index drugs within 14 days or 5 half-lives before randomization
- Used any glucose-lowering medication within 10 weeks before consent (except short-term insulin under 14 days)
- Used GLP-1 analogues within 3 months prior or discontinued due to safety or lack of efficacy
- Pregnant or breastfeeding
- Known allergy to GLP-1 receptor agonists or severe drug allergies
- Participated in other clinical trials within 3 months or 5 half-lives before consent
- Any other condition deemed unsuitable by investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Peking University People's Hospital
Beijing, Beijing Municipality, China, 100000
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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