Comparison Study of Insulin GZR4 With Insulin Degludec

NCT07146347 | Recruiting Phase 1

• 1 other identifier: GL-ULI-1001
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• To investigate the PD of GZR4 compared to insulin degludec at steady state

  AUCGIR.0-24h.ss, area under the glucose infusion rate curve over one dosing interval from 0 to 24 hours at steady state for insulin degludec AUCGIR.0-168h.ss, area under the glucose infusion rate curve over one dosing interval from 0 to 168 hours at steady state for GZR4

  0 - 24 hours for Degulec 0-168 hours for GZR4

Study Arms (1)

All participants will receive all three treatments in a fixed-sequence design.

EXPERIMENTAL

Each participant will undergo 3 treatment periods in a fixed-sequence design. In treatment Period 1, participants will receive insulin degludec once-daily for 7 days. In treatment Period 2, participants will receive GZR4, in treatment Period 3, participants will receive insulin icodec. Both GZR4 insulin and insulin icodec will be given once weekly over 6 weeks during two treatment periods.

Drug: GZR4 injection

Interventions

GZR4 injection DRUG

GZR4 is a new ultra-long-acting insulin analog

Also known as: Degludec, Icodec

All participants will receive all three treatments in a fixed-sequence design.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed and dated informed consent obtained before any trial-related activities. Trial-related activities are any procedures that would not have been done during normal management of the participant. 2. Male or female person with type 2 diabetes mellitus. 3. Age between 18 and 70 years, both inclusive. 4. Body Mass Index (BMI) between 27.0 and 38.0 kg/m\^2, both inclusive. 5. Diabetes duration of at least 12 months. 6. Stable basal insulin regimen for at least 3 months. 7. Total daily basal insulin dose between 0.2-0.7 (I)U/kg/day, both inclusive. 8. HbA1c \<= 9.0%. 9. Have venous access sufficient to allow cannulation for blood sampling as required by the protocol.

You may not qualify if:

• Known or suspected hypersensitivity to IMPs or any of the excipients or to any component of the IMP formulations. 2. Previous participation in this trial. Participation is defined as randomized at Visit 2.
• \. Recurrent severe hypoglycemia (more than 1 severe hypoglycemic episode requiring assistance from another person within 180 days before screening). 18. Hypoglycemic unawareness as judged by the investigator. 19. Hospitalization for diabetic ketoacidosis during the previous 6 months. 20. Use of oral antidiabetic drugs (OADs) within 1 month or 5 half-times (whichever is longer) prior to screening with the exception of stable doses (for at least 3 months prior to screening) of metformin, DPP4, SGLT2 inhibitors and GLP-1 receptor agonists. 21. Increased risk of thrombosis, e.g. participants with a history of deep leg vein thrombosis or family history of deep leg vein thrombosis, as judged by the investigator. 22. Significant history of alcoholism or drug abuse as judged by the investigator or consuming more than 24.0 grams alcohol/day (for males), 12.0 grams alcohol/day (for females) on average. 23. A positive result in the alcohol and/or urine drug screen at the screening visit.
• \. Mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation. 33. Committed to an institution by virtue of an order issued either by the judicial or the administrative authorities. 34. If female, pregnancy or breast-feeding. 35. Women of childbearing potential who are not using a highly effective contraceptive method.

Sponsors & Collaborators

• Gan and Lee Pharmaceuticals, USA: lead
• Profil Institut für Stoffwechselforschung GmbH: collaborator

Study Sites (1)

Profil

Neuss, Germany

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

insulin degludec; insulin icodec

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Andre Feldmann

CONTACT

+49 (0) 2131 4018 409; Andre.Feldmann@profil.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2025
• First Posted: August 28, 2025
• Study Start: August 15, 2025
• Primary Completion: April 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: August 28, 2025

Record last verified: 2025-08

Locations

DE (1)