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The Effectivity and Safety Study of rExenatide-4 in Chinese Type 2 Diabetes Mellitus
A Phase 3, Randomized, Double-Blind,Placebo-Controlled, Multicenter Study to Examine the Effect on Glucose Control (HbA1c) and Safety of rE-4 in Subjects With Type 2 Diabetes Mellitus Treated With Metformin, a Sulfonylurea, or Metformin and Sulfonylurea Combination
Lead sponsor
Asset
Exenatide
GLP-1 agonist
Listed sites
0
Recruiting sites
—
Enrollment
456
estimated
Study population
Type 2 diabetes
Key I/E criteria
•BMI ≤35•HbA1c ≤11%
Primary endpoint
•HbA1c, change
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
1. T2DM
2. 7.0% ≤ HbA1c ≤ 11.0% at screening
3. FPG ≤13.8 mmol/L
4. 19 kg/m2 < BMI <35.0 kg/m2 at screening
5. All subjects provided written informed consent before participation
Exclusion criteria
1. T1DM
2. Patients treated previously with Exenatide or GLP-1 similar
3. At screening visit alanine aminotransferase (ALT) or alkaline phosphatase (AST) more than 2.5 ULN
4. At screening visit estimated glomerular filtration rate (eGFR) ≤ 60 mL/min or Triglyceride(TG)≥ 5 mmol/L
5. Pancreatitis, cholecystitis, gallstones and other gastrointestinal diseases
6. Within the last 12 months prior to screening visit: history of stroke, myocardial infarction, unstable angina, or heart failure requiring hospitalization. Planned coronary, carotid or peripheral artery revascularisation procedures to be performed during the study period
7. History of digestive diseases (e.g.pancreatitis, cholecystitis or gallstones)
8. Patients with severe renal impairment or end-stage renal disease
9. Uncontrolled or inadequately controlled hypertension (systolic blood pressure above 180 mmHg or diastolic blood pressure above 110 mmHg) at screening visit.
10. Use of weight loss drugs within 3 months prior to screening visit
11. Have been treated with exogenous insulin, α-glucosidase, corticosteroid, DPP-4 inhibitor or pramlintide acetate within the 3 months prior to screening.
12. Severe gastrointestinal disease (e.g., gastroparesis)
13. Pregnancy or lactation, women of childbearing potential with no effective contraceptive method
14. Participant who participated in any drug clinical trial within the last 3 months prior to screening visit
15. History of severe hypersensitivity to rExenatide-4 or any product components
Endpoints (5)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Weight & body composition
1 endpointChange in body weight from Baseline to each intermediate visit and Week 30
Time frame:Baseline (Day 1), Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 30
Body weight, absolute change (kg)
change from baseline, improvement
Glycemic / diabetes
4 endpointsChange in HbA1c from Baseline to Week 30
Time frame:Baseline (Day 1) to Week 30
HbA1c, change
change from baseline, improvement
LOINC 4548-4
The number of subjects achieving HbA1c target values of < 7% and ≤ 6.5% by Week 30
Time frame:Baseline (Day 1) and Week 30
HbA1c <7.0% achievement
threshold achievement, improvement
LOINC 4548-4
Change in FPG from Baseline to each intermediate visit and Week 30
Time frame:Baseline (Day 1), Week 2, Week 4, Week, 6, Week 12, Week 18, Week 24, Week 30
Fasting glucose, change
change from baseline, improvement
LOINC 1558-6
Change in 7-SMBG from Baseline to Week 16，Week 24 and Week 30
Time frame:Baseline, Week 16，Week 24 and Week 30
Postprandial glucose
change from baseline, improvement
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.