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
Overview
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- Gan and Lee Pharmaceuticals, USA
- Enrollment
- 14
- Locations
- 1
- Primary Endpoint
- To investigate the PD of GZR4 compared to insulin degludec at steady state
Overview
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.
Detailed Description
This trial intends to investigate the pharmacodynamics, pharmacokinetics, safety, and tolerability of insulin GZR4 (hereafter referred to as GZR4) and estimate its potency in comparison with insulin degludec.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
- •Male or female person with type 2 diabetes mellitus.
- •Age between 18 and 70 years, both inclusive.
- •Body Mass Index (BMI) between 27.0 and 38.0 kg/m\^2, both inclusive.
- •Diabetes duration of at least 12 months.
- •Stable basal insulin regimen for at least 3 months.
- •Total daily basal insulin dose between 0.2-0.7 (I)U/kg/day, both inclusive.
- •HbA1c \<= 9.0%.
- •Have venous access sufficient to allow cannulation for blood sampling as required by the protocol.
Exclusion Criteria
- •Known or suspected hypersensitivity to IMPs or any of the excipients or to any component of the IMP formulations.
- •Previous participation in this trial. Participation is defined as randomized at Visit
- •3\. Receipt of any medicinal product in clinical development within 30 days or at least 5 half-lives of the related substances and their metabolites (whichever is longer) before randomization in this trial.
- •Use of insulin icodec as basal insulin.
- •History of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction.
- •Any history or presence of cancer except basal cell skin cancer or squamous cell skin cancer as judged by the investigator during the last 5 years prior to screening.
- •Clinically relevant comorbidity, capable of constituting a risk for the participant when participating in the trial or of interfering with the interpretation of data. Signs of acute illness as judged by the investigator.
- •Any serious systemic infectious disease during four weeks before randomization in this trial, as judged by the investigator.
- •Clinically significant abnormal values for hematology, biochemistry, coagulation, or urinalysis as judged by the investigator.
- •Estimated glomerular filtration rate (eGFR) \< 60.0 mL/min/1.73m
Arms & Interventions
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.
Intervention: GZR4 injection (Drug)
Outcomes
Primary Outcomes
To investigate the PD of GZR4 compared to insulin degludec at steady state
Time Frame: 0 - 24 hours for Degulec 0-168 hours for GZR4
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
Secondary Outcomes
No secondary outcomes reported