A Trial to Evaluate Pharmacodynamics, Pharmacokinetics, Safety, and Tolerability of Insulin GZR4 Compared With Insulin Degludec and Insulin Icodec in Participants With Type 2 Diabetes

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
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• 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.

Locations
Other Locations
Germany
Profil
RECRUITING
Neuss
Contact Information
Primary
Andre Feldmann
Andre.Feldmann@profil.com
+49 (0) 2131 4018 409
Time Frame
Start Date: 2025-08-15
Estimated Completion Date: 2026-06-01
Participants
Target number of participants: 14
Treatments
Experimental: All participants will receive all three treatments in a fixed-sequence design.
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.
Related Therapeutic Areas
Sponsors
Collaborators: Profil Institut für Stoffwechselforschung GmbH
Leads: Gan and Lee Pharmaceuticals, USA

This content was sourced from clinicaltrials.gov