Phase 2 Study of HEC88473 Injection in Subjects With Type 2 Diabetes Mellitus
NCT ID: NCT06148649
Last Updated: 2025-04-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
234 participants
INTERVENTIONAL
2023-12-10
2025-04-23
Brief Summary
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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).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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HEC88473 dose1
T2DM subjects, receiving a weekly dose of HEC88473 dose1
HEC88473, Placebo, Dulaglutide
T2DM subjects, receiving a weekly dose of HEC88473, placebo or dulaglutide.
HEC88473 dose2
T2DM subjects, receiving a weekly dose of HEC88473 dose2
HEC88473, Placebo, Dulaglutide
T2DM subjects, receiving a weekly dose of HEC88473, placebo or dulaglutide.
HEC88473 dose3
T2DM subjects, receiving a weekly dose of HEC88473 dose3
HEC88473, Placebo, Dulaglutide
T2DM subjects, receiving a weekly dose of HEC88473, placebo or dulaglutide.
Placebo
T2DM subjects, receiving a weekly dose of placebo
HEC88473, Placebo, Dulaglutide
T2DM subjects, receiving a weekly dose of HEC88473, placebo or dulaglutide.
Dulaglutide
T2DM subjects, receiving a weekly dose of dulaglutide
HEC88473, Placebo, Dulaglutide
T2DM subjects, receiving a weekly dose of HEC88473, placebo or dulaglutide.
Interventions
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HEC88473, Placebo, Dulaglutide
T2DM subjects, receiving a weekly dose of HEC88473, placebo or dulaglutide.
Eligibility Criteria
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Inclusion Criteria
2. Have T2DM for at least 3 months before screening based on the disease diagnostic criteria (WHO 1999).
3. Have an HbA1c value of ≥7.5% and ≤10.5%, fasting blood-glucose ≤13.9 mmoL/L, at screening and visit 3.
Exclusion Criteria
2. 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).
3. 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.
4. Have a personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2) at screening.
5. Have serum calcitonin ≥20 ng/L at screening.
6. Fasted triglycerides \> 5.7 mmol/L at screening.
18 Years
75 Years
ALL
No
Sponsors
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Dongguan HEC Biopharmaceutical R&D Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Peking University People's Hospital
Beijing, Beijing Municipality, China
Shijiazhuang People's Hospital
Shijiazhuang, Hebei, China
Countries
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Other Identifiers
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HEC88473-DM-201
Identifier Type: -
Identifier Source: org_study_id
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