Gan & Lee Pharmaceuticals: Diabetes Mellitus trials

The registry lists 16 Diabetes Mellitus studies with Gan & Lee Pharmaceuticals as lead sponsor. 1 are open to participants now and 2 have results posted.

Phase 1 7Phase 2 3Phase 3 7(a study in two phases counts in both)

Studies

Open to participants first, then studies with results posted, then the rest; newest registration first within each.

• A Phase IIIb Clinical Study to Assess the Efficacy and Safety of GZR4 in Subjects With Type 2 Diabetes Mellitus Treated With Basal InsulinRecruitingNCT07165223Phase 3
• Gan & Lee Insulin Glargine Target Type (2) Evaluating ResearchCompletedNCT03371108Phase 3Results posted
• Gan & Lee Insulin Glargine Target Type (1) Evaluating ResearchCompletedNCT03371082Phase 3Results posted
• Pharmacokinetic and Safety Study of GZR4 Injection in Subjects With Hepatic ImpairmentActive, not recruitingNCT07193147Phase 1
• A Phase III Clinical Study to Assess the Efficacy and Safety of GZR4 in Type 2 Diabetes Mellitus Subjects (T2DM) Treated With Basal + Prandial InsulinActive, not recruitingNCT06767761Phase 3
• A Phase III Clinical Study to Assess the Efficacy and Safety of GZR4 in Subjects With Type 2 Diabetes Mellitus Treated With Basal InsulinActive, not recruitingNCT06767748Phase 3
• A Phase III Clinical Study to Assess the Efficacy and Safety of GZR4 in Insulin-naive Subjects With Type 2 Diabetes Mellitus (T2DM)Active, not recruitingNCT06767735Phase 3
• A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GZR4 in Subjects With Type 2 DiabetesCompletedNCT06553248Phase 1
• A Study of GZR18 Injection in Chinese Patients With Type 2 Diabetes MellitusActive, not recruitingNCT06256549Phase 2
• A Study of GZR18 Injection in Chinese Adult Patients With Type 2 Diabetes Mellitus (T2DM)CompletedNCT06256523Phase 1/2
• A Trial Comparing the Efficacy and Safety of GZR4 Injection Versus Insulin Degludec in Subjects with Type 2 Diabetes MellitusCompletedNCT06202079Phase 2
• Gan & Lee Evaluation of New Biosimilar for Type 1 LisproWithdrawnNCT04254380Phase 3
• PK/PD Study of Gan & Lee Insulin Aspart Injection vs. US & EU NovoLog®/NovoRapid® in Healthy MalesCompletedNCT04237129Phase 1
• PK/PD Biosimilarity Study of Gan & Lee Insulin Glargine Injection vs.US & EU Lantus® in Type 1 Diabetes Mellitus PatientsCompletedNCT04236895Phase 1
• PK/PD Biosimilarity Study of Gan & Lee Insulin Lispro Injection vs. EU and US Humalog® in Healthy MalesCompletedNCT04235439Phase 1
• PK/PD Study of Gan & Lee's Insulin Glargine Injection in Comparison to Lantus in Type 1 DiabetesCompletedNCT02506647Phase 1