A Phase 2 interventional study of HEC88473, Placebo, Dulaglutide in Type 2 Diabetes, sponsored by Dongguan HEC Biopharmaceutical R&D Co., Ltd.. Completed at 2 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-04-29.
Sponsored by Dongguan HEC Biopharmaceutical R&D Co., Ltd. · Phase 2, Interventional, and Treatment
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.
Patients treated with diet and exercise alone, or in combination with stable metformin monotherapy (≥1500 mg/day or maximum tolerated dose ≥1000 mg/ day.), will be enrolled. Approximately 225 participants will be randomized. The study includes four stages: screening period (up to 2 weeks), lead-in period (2 weeks), treatment period (12 weeks) and safety follow-up period (3 weeks after treatment).
10,923 studies on the registry are indexed under Diabetes Mellitus; 1,318 are open to participants now.
This study's enrollment of 234 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Dongguan HEC Biopharmaceutical R&D Co., Ltd. is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
T2DM subjects, receiving a weekly dose of HEC88473 dose1
Drug: HEC88473, Placebo, Dulaglutide
T2DM subjects, receiving a weekly dose of HEC88473 dose2
Drug: HEC88473, Placebo, Dulaglutide
T2DM subjects, receiving a weekly dose of HEC88473 dose3
Drug: HEC88473, Placebo, Dulaglutide
T2DM subjects, receiving a weekly dose of placebo
Drug: HEC88473, Placebo, Dulaglutide
T2DM subjects, receiving a weekly dose of dulaglutide
Drug: HEC88473, Placebo, Dulaglutide
T2DM subjects, receiving a weekly dose of HEC88473, placebo or dulaglutide.
Change from baseline of HbA1c at week 12
HbA1c
Time frame: Baseline to week 12
Change from baseline of weight at week 12
weight
Time frame: Baseline to week 12
Change from baseline of fasting blood-glucose at week 12
fasting blood-glucose
Time frame: Baseline to week 12
Frequency and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Baseline to week 15
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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Dongguan HEC Biopharmaceutical R&D Co., Ltd.