Comparing two injections for managing type 2 diabetes
A Phase II Trial Comparing Efficacy, Tolerability, and Safety of GZR101 Injection and GZR33-70 Injection in Type 2 Diabetes Inadequately Controlled on Basal Insulin or Premixed Insulin Once Daily at Least With or Without Pre-dinner Meal-time Insulin
This study tests which of two daily injections can help adults with type 2 diabetes better manage their blood sugar when insulin isn't enough.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Gan and Lee Pharmaceuticals, USA Industry-sponsored |
| Locations | 1 site (Tianjin) |
| Trial ID | NCT06558708 on ClinicalTrials.gov |
What this trial studies
This trial aims to evaluate the efficacy, tolerability, and safety of two different injections, GZR101 and GZR33-70, in patients with type 2 diabetes who are inadequately controlled on insulin. Participants will receive one of the injections once daily, with the goal of determining which treatment provides better management of their diabetes. The study is being conducted in China and includes adults aged 18 to 75 who have been diagnosed with type 2 diabetes for at least six months.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 with type 2 diabetes who are not adequately controlled on their current insulin regimen.
Not a fit: Patients with a history of severe hypoglycemia or acute heart failure may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options for patients with type 2 diabetes, enhancing their blood sugar control.
How similar studies have performed: Other studies have shown promise in comparing different insulin therapies, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Tianjin
- Study Site 01 — Tianjin, China (Recruiting)
Study contacts
- Study coordinator: Baozhuo Wang
- Email: baozhuo.wang@ganlee.com
- Phone: 01056456746
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.