Type 2 Diabetes
Conditions
Brief summary
The main purpose of this study is to evaluate the efficacy and safety of HRS-4729 Injection in participants with type 2 diabetes who failed to achieve adequate glycemic control on diet and exercise alone or on a stable dose of metformin.
Interventions
Sponsors
Fujian Shengdi Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
A Phase II, Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled, Parallel-Group Clinical Study
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Have Type 2 Diabetes 2. Treated with diet and exercise alone or with a stable dose of metformin 3. Have an HbA1c value at screening of ≥7.5% and ≤10.5%
Exclusion criteria
1. Have uncontrolled hypertension 2. Have Type 1 Diabetes, or specific types of diabetes 3. History of acute diabetic complications or severe hypoglycemic events 4. History of severe chronic diabetic complications, or non-proliferative diabetic retinopathy requiring treatment 5. History of any condition affecting gastric emptying, long-term use of medications directly affecting gastrointestinal motility, severe gastrointestinal disease, or prior gastrointestinal surgery 6. History or known history of acute or chronic pancreatitis, or pancreatic injury 7. History or known history of acute cholecystitis, or symptomatic/treatment-requiring gallbladder disease 8. Personal or family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia type 2 (MEN2)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change From Baseline in HbA1c | Baseline, Week 28 |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of Participants Reaching HbA1c <7.0%, ≤6.5%, and <5.7% | Baseline, Week 28 |
| Percent Change From Baseline in Body Weight | Baseline, Week 28 |
| Change From Baseline in Fasting Plasma Glucose | Baseline, Week 28 |
| TEAEs | Baseline, Week 32 |
Countries
China
Contacts
CONTACTMengshan Ni, M.D.
Outcome results
None listed