A Trial Comparing Efficacy and Safety of GZR101 and IDegAsp in Insulin Naïve or Insulin Treated Subjects with T2DM
NCT ID: NCT06199505
Last Updated: 2025-01-17
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
153 participants
INTERVENTIONAL
2023-11-21
2024-07-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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GZR101
GZR101 injection s.c., once daily, treat-to-target dose
GZR101
Once daily
insulin degludec/insulin aspart,
insulin degludec/insulin aspart injection s.c., once or twice daily, treat-to-target dose
insulin degledec/insulin aspart
Once daily or twice daily
Interventions
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GZR101
Once daily
insulin degledec/insulin aspart
Once daily or twice daily
Eligibility Criteria
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Inclusion Criteria
* BMI = 18.5-35 kg/m2 (inclusive) at screening.
* Diagnosed with type 2 diabetes mellitus for ≥ 6 months.
* 7.0% ≤ HbA1c ≤ 11.0% at screening.
Exclusion Criteria
* Subjects with any malignancy diagnosed prior to screening or documented history of malignancy.
* Those with the following diseases within 6 months prior to screening: diabetic ketoacidosis, diabetic lactic acidosis, or hyperosmolar nonketotic diabetic coma.
* Subjects experiencing serious hypoglycaemic events (Level 3 hypoglycaemia) within 3 months prior to screening.
* Subjects with with history of acute heart failure or having been hospitalized for coronary heart disease, myocardial infarction, unstable angina, or stroke within 6 months prior to screening.
* Known or suspected hypersensitivity to trial product(s).
* Participation in a clinical study of another study drug within 1 month prior to randomization.
18 Years
75 Years
ALL
No
Sponsors
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Gan and Lee Pharmaceuticals, USA
INDUSTRY
Responsible Party
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Principal Investigators
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Chunyue Hao, PhD
Role: STUDY_DIRECTOR
Gan & Lee Pharmaceuticals.
Locations
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Gan & Lee Pharmaceuticals Co., Ltd
Beijing, Beijing Municipality, China
Countries
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Other Identifiers
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GL-GZR-CH2006
Identifier Type: -
Identifier Source: org_study_id
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