Trial Profile

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

Status: Not yet recruiting

Phase of Trial: Phase II

Latest Information Update: 07 May 2026

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At a glance

Drugs Insulin aspart biosimilar/long acting insulin fixed dose combination Gan and Lee Pharmaceuticals (Primary) ; Insulin degludec/insulin aspart
Indications Type 2 diabetes mellitus
Focus Therapeutic Use
Sponsors Gan&Lee Pharmaceuticals

15 Apr 2026 Planned number of patients changed from 300 to 345.
15 Apr 2026 Planned End Date changed from 17 Aug 2027 to 23 Sep 2027.
15 Apr 2026 Planned primary completion date changed from 22 Apr 2027 to 11 Feb 2027.

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