Comparison Study of Insulin GZR4 With Insulin Degludec
NCT07146347 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14
Last updated 2025-08-28
Summary
In this study, the investigational product will be compared with insulin degludec (Tresiba®) and insulin icodec (Awiqli®). The comparator products are approved for the treatment of T2DM in the European Union.
Conditions
Interventions
- DRUG
-
GZR4 injection
GZR4 is a new ultra-long-acting insulin analog
Sponsors & Collaborators
-
Profil Institut für Stoffwechselforschung GmbH
collaborator INDUSTRY -
Gan and Lee Pharmaceuticals, USA
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-08-15
- Primary Completion
- 2026-04-01
- Completion
- 2026-06-01
Countries
- Germany
Study Locations
More Related Trials
-
Insulin Glulisine in Diabetes Mellitus, Type 2
NCT00174668 ·Status: COMPLETED ·Phase: PHASE3
-
A Comparative Study of LY900014 to Insulin Lispro (Humalog) in Healthy Participants
NCT03286751 ·Status: COMPLETED ·Phase: PHASE1
-
A Phase III Clinical Study to Assess the Efficacy and Safety of GZR4 in Type 2 Diabetes Mellitus Subjects (T2DM) Treated With Basal + Prandial Insulin
NCT06767761 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
A Research Study to See How Switching From a Daily Basal Insulin to a New Weekly Insulin, Insulin Icodec, Helps in Reducing the Blood Sugar Compared to Daily Insulin Glargine in Adults With Type 2 Diabetes
NCT06340854 ·Status: COMPLETED ·Phase: PHASE3
-
A Research Study to Compare Two Types of Insulin, a New Insulin, Insulin Icodec and an Available Insulin, Insulin Degludec, in People With Type 2 Diabetes Who Have Not Used Insulin Before (ONWARDS 3)
NCT04795531 ·Status: COMPLETED ·Phase: PHASE3
-
Comparing Pharmacodynamic and Pharmacokinetic Properties of Insulin Degludec and Insulin Glargine 300 U/mL at Steady-state Conditions in Subjects With Type 1 Diabetes Mellitus
NCT02536859 ·Status: COMPLETED ·Phase: PHASE1
-
A Research Study to Compare Two Types of Insulin, a New Insulin, Insulin Icodec and an Available Insulin, Insulin Glargine, in People With Type 2 Diabetes Who Have Not Used Insulin Before
NCT04460885 ·Status: COMPLETED ·Phase: PHASE3
-
A Study Comparing Subcutaneous Rapid Acting Insulin and One Formulation of Inhaled Insulin in Subjects With Type 2 Diabetes
NCT00570687 ·Status: COMPLETED ·Phase: PHASE2
-
A Trial Comparing the Efficacy and Safety of Insulin Degludec/Liraglutide Versus Insulin Glargine in Subjects With Type 2 Diabetes Mellitus
NCT01952145 ·Status: COMPLETED ·Phase: PHASE3
-
Liraglutide or Insulin in Real Life Usage in Patients With Diabetes Mellitus Type 2
NCT01484262 ·Status: COMPLETED
-
Insulin Glargine Plus Insulin Glulisine Multiple Daily Injections (MDI) Versus Premix Insulin Treatment in Subjects With Diabetes Mellitus (Type 1 or Type 2)
NCT00135941 ·Status: COMPLETED ·Phase: PHASE3
-
Insulin Glargine in Type 2 Diabetic Patients
NCT00347100 ·Status: COMPLETED ·Phase: PHASE4
-
A Trial Comparing the Efficacy and Safety of Insulin Degludec/Liraglutide, Insulin Degludec and Liraglutide in Japanese Subjects With Type 2 Diabetes Mellitus.
NCT02607306 ·Status: COMPLETED ·Phase: PHASE3
-
Insulin Glulisine, Insulin Lispro and Insulin Glargine in Type 1 or 2 Diabetes Mellitus
NCT00467376 ·Status: COMPLETED ·Phase: PHASE3
-
The Effect of Insulin Degludec in Combination With Liraglutide and Metformin in Subjects With Type 2 Diabetes Qualifying for Treatment Intensification
NCT01664247 ·Status: COMPLETED ·Phase: PHASE3
-
A Research Study to Compare Two Types of Insulin, a New Weekly Insulin, Insulin Icodec and an Available Daily Insulin, Insulin Degludec, in People With Type 2 Diabetes Who Use Daily Insulin
NCT04770532 ·Status: COMPLETED ·Phase: PHASE3
-
Insulin Glulisine in Type 2 Diabetes Mellitus
NCT00310297 ·Status: COMPLETED ·Phase: PHASE1
-
A Trial Comparing the Efficacy of Insulin Degludec With Insulin Glargine on Glycaemic Control Using Continuous Glucose Monitoring in Patients With Type 1 Diabetes
NCT01569841 ·Status: COMPLETED ·Phase: PHASE3
-
Insulin Glulisine in Type 2 Diabetic Patients
NCT00360698 ·Status: COMPLETED ·Phase: PHASE4
-
A Study of LY900014 Compared to Insulin Lispro in Participants With Type 2 Diabetes
NCT03214380 ·Status: COMPLETED ·Phase: PHASE3
-
Effect of Treatment With Insulin VIAjectTM Compared to Regular Human Insulin and Insulin Lispro on Mealtime Blood Vessel Stress in Patients With Type 2 Diabetes Mellitus.
NCT00849576 ·Status: COMPLETED ·Phase: PHASE3
-
PK/PD Biosimilarity Study of Gan & Lee Insulin Lispro Injection vs. EU and US Humalog® in Healthy Males
NCT04235439 ·Status: COMPLETED ·Phase: PHASE1
-
A Clinical Study to Compare the Efficacy and Safety of a Novel Medicine (NNC0268-0965) With Insulin Glargine
NCT04575181 ·Status: COMPLETED ·Phase: PHASE1
-
PK/PD Biosimilarity Study of Gan & Lee Insulin Glargine Injection vs.US & EU Lantus® in Type 1 Diabetes Mellitus Patients
NCT04236895 ·Status: COMPLETED ·Phase: PHASE1
-
Dose Range Finding Study of MK-0941 in Patients With Type 2 Diabetes Mellitus on Insulin (MK-0941-007 AM3 EXT1 AM1)(TERMINATED)
NCT00767000 ·Status: TERMINATED ·Phase: PHASE2