Actively Recruiting
Comparison Study of Insulin GZR4 With Insulin Degludec
Led by Gan and Lee Pharmaceuticals, USA · Updated on 2025-08-28
14
Participants Needed
1
Research Sites
41 weeks
Total Duration
On this page
Sponsors
G
Gan and Lee Pharmaceuticals, USA
Lead Sponsor
P
Profil Institut für Stoffwechselforschung GmbH
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Comparison Study of Insulin GZR4 With Insulin Degludec
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent obtained before any trial-related activities
- Male or female with type 2 diabetes mellitus
- Age between 18 and 70 years, inclusive
- Body Mass Index (BMI) between 27.0 and 38.0 kg/m², 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 and 0.7 IU/kg/day, inclusive
- HbA1c less than or equal to 9.0%
- Venous access sufficient for blood sampling as required by the protocol
You will not qualify if you...
- Known or suspected hypersensitivity to investigational medicinal products or their components
- Previous participation in this trial (randomized at Visit 2)
- Use of any medicinal product in clinical development within 30 days or 5 half-lives before randomization
- Use of insulin icodec as basal insulin
- History of multiple or severe allergies or severe anaphylactic reaction
- History or presence of cancer except basal cell or squamous cell skin cancer within last 5 years
- Clinically relevant comorbidity or signs of acute illness
- Serious systemic infection within 4 weeks before randomization
- Clinically significant abnormal hematology, biochemistry, coagulation, or urinalysis
- Estimated glomerular filtration rate (eGFR) less than 60 mL/min/1.73m²
- Blood pressure outside specified ranges at screening
- Heart rate outside 50-90 beats per minute at screening
- Clinically significant abnormal ECG after 5 minutes rest
- Proliferative retinopathy or maculopathy based on recent ophthalmologic exam
- Severe neuropathy, especially autonomic neuropathy
- Recurrent severe hypoglycemia or hypoglycemic unawareness
- Hospitalization for diabetic ketoacidosis within 6 months
- Use of certain oral antidiabetic drugs within 1 month prior to screening except stable metformin, DPP4, SGLT2 inhibitors, and GLP-1 receptor agonists
- Increased risk of thrombosis
- Significant history of alcoholism or drug abuse or high alcohol consumption
- Positive alcohol or drug screen at screening
- Smoking more than 5 cigarettes per day or inability to refrain from smoking during inpatient period
- Positive tests for hepatitis B, hepatitis C (unless liver function normal and PCR negative), or HIV
- Current treatment with systemically effective corticosteroids or other prohibited medications
- Use of non-prescription medications interfering with study drugs within 2 weeks prior to screening
- Blood donation or loss of more than 500 mL within last 3 months
- Mental incapacity, unwillingness, or language barriers
- Commitment to an institution by judicial or administrative order
- Pregnancy or breastfeeding
- Women of childbearing potential not using highly effective contraception
- Men with partners of childbearing potential not willing to use condoms plus contraception
- Investigator judgment of unsuitability for other reasons
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Profil
Neuss, Germany
Actively Recruiting
Research Team
A
Andre Feldmann
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here