NCT06558708 A Trial Comparing Efficacy, Tolerability, and Safety of GZR101 Injection Once Daily (OD) and GZR33-70 Injection OD
| NCT ID | NCT06558708 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Gan and Lee Pharmaceuticals, USA |
| Condition | Type 2 Diabetes |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-06-28 |
| Primary Completion | 2024-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 60 participants in total. It began in 2024-06-28 with a primary completion date of 2024-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This trial is conducted in China. The aim of the trial is to compare the efficacy, tolerability, and safety of GZR101 Injection and GZR33-70 Injection in type 2 diabetes inadequately controlled on basal/ premixed insulin once daily at least with or without pre-dinner meal-time insulin.
Eligibility Criteria
Inclusion Criteria: * 1\. Signed the informed consent form (ICF) before the trial, fully understanding the trial content, process and possible adverse reactions, and being able to comply with the contraindications and restrictions specified in this protocol. * 2.At the age of 18-75 (inclusive) at the time of informed consent, male or female. * 3.Negative pregnancy test results for serum human chorionic gonadotropin (HCG) in women of childbearing potential at screening. * 4.Diagnosed with type 2 diabetes mellitus above or equal to 6 months. Exclusion Criteria: * 1.Presence or history of malignant neoplasm prior to screening. * 2.Known or suspected hypersensitivity to investigational medical product(s) or related products. * 3.Severe hypoglycemia (Level 3 hypoglycemia) within 6 months prior to screening. * 4.History of acute heart failure within 6 months prior to screening or hospitalization for coronary heart disease, myocardial infarction, unstable angina, stroke within 6 months prior to screening. * 5\. Participated in another interventional clinical study within 4 weeks prior to randomization.
Contact & Investigator
Clinical Transparency
STUDY DIRECTOR
Gan & Lee Pharmaceuticals.
Frequently Asked Questions
Who can join the NCT06558708 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Type 2 Diabetes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06558708 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06558708 currently recruiting?
Yes, NCT06558708 is actively recruiting participants. Contact the research team at baozhuo.wang@ganlee.com for enrollment information.
Where is the NCT06558708 trial being conducted?
This trial is being conducted at Tianjin, China.
Who is sponsoring the NCT06558708 clinical trial?
NCT06558708 is sponsored by Gan and Lee Pharmaceuticals, USA. The principal investigator is Clinical Transparency at Gan & Lee Pharmaceuticals.. The trial plans to enroll 60 participants.
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