Study S003412

A Multicenter Phase 2 Clinical Study to Evaluate the Efficacy and Safety of GZR101-80 Injection in Patients With Type 2 Diabetes Mellitus Inadequately Controlled on Oral Antidiabetic Drugs or Patients With Type 2 Diabetes Mellitus Inadequately Controlled on Basal Insulin

ClinicalTrials.gov record

Registration

Registration: NCT07387003
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE2
Masking: NONE
Status: NOT_YET_RECRUITING
Enrollment: 345
Start: 2026-04-10
Primary completion: 2027-02-11
Lead sponsor: Gan & Lee Pharmaceuticals.
Conditions: Type 2 Diabetes (T2DM)
Interventions: DRUG:GZR101-80; DRUG:GZR33 or Insulin degludec/Insulin aspart or Insulin aspart30 (NovoRapid®30)
Results posted: FALSE

Registered primary outcomes

Change in Hemoglobin A1c (HbA1c) from baseline after 16 weeks of treatment. [Baseline , 16 weeks]

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