Status:
COMPLETED
Phase 2 Study of HEC88473 Injection in Subjects With Type 2 Diabetes Mellitus
Lead Sponsor:
Dongguan HEC Biopharmaceutical R&D Co., Ltd.
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
This is a multicenter, randomized, parallel, placebo- and active comparator-controlled phase 2 trial to evaluate the efficacy, safety, pharmacokinetics and immunogenicity in subjects with T2DM. Patie...
Eligibility Criteria
Inclusion
- Male or female patients 18 to 75 years of age, inclusive.
- Have T2DM for at least 3 months before screening based on the disease diagnostic criteria (WHO 1999).
- Have an HbA1c value of ≥7.5% and ≤10.5%, fasting blood-glucose ≤13.9 mmoL/L, at screening and visit 3.
Exclusion
- Have type 1 diabetes mellitus.
- Have had ≥1 episode of severe hypoglycemia within 6 months before screening, or history of recurrent hypoglycemia (history of hypoglycemia more than 3 times in 3 months).
- Have acute or chronic hepatitis, signs and symptoms of any other liver disease other than nonalcoholic fatty liver disease (NAFLD), or alanine aminotransferase (ALT) level \>2.5 times the upper limit of the reference range at screening.
- Have a personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2) at screening.
- Have serum calcitonin ≥20 ng/L at screening.
- Fasted triglycerides \> 5.7 mmol/L at screening.
Key Trial Info
Start Date :
December 10 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 23 2025
Estimated Enrollment :
234 Patients enrolled
Trial Details
Trial ID
NCT06148649
Start Date
December 10 2023
End Date
April 23 2025
Last Update
April 29 2025
Active Locations (2)
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1
Peking University People's Hospital
Beijing, Beijing Municipality, China, 100044
2
Shijiazhuang People's Hospital
Shijiazhuang, Hebei, China, 050000