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Tests treatment safety and results for Diabetes
Official title A Phase IIIb Clinical Study to Assess the Efficacy and Safety of GZR4 in Subjects With Type 2 Diabetes Mellitus Treated With Basal Insulin
ClinicalTrials.gov ID: NCT07165223
What this study is testing
What is GZR4?
GZR4 is an investigational medicine, given as an once-weekly injection under the skin, being studied as a potential treatment for diabetes.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study will be conducted to compare the efficacy, safety and patient-reported outcome of GZR4 and Insulin Icodec with or without Non-Insulin Antidiabetic Agents in subjects with Type 2 Diabetes Mellitus (T2DM) treated with basal insulin.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Sign the Informed Consent Form (ICF) before the study, fully understand the contents, process and possible adverse reactions of the study, and be...
- Males and females age ≥ 18 years at the time of informed consent.
- The pregnancy test for β-human chorionic gonadotropin (hCG) must be negative for women of childbearing potential during the screening period and...
- From signing the Informed Consent Form until 3 weeks after the end of treatment, female people of childbearing potential and male people and their...
- According to the diagnostic criteria and classification of diabetes mellitus issued by the World Health Organization (WHO) in 1999, and the...
You likely can't join if
- A history of allergy to drugs with two or more mechanisms of action in the past, or known allergies, hypersensitivity, or intolerance to the...
- people who are pregnant, lactating or planning to become pregnant during the study at screening.
- Participated in any drug clinical study (received non-placebo medication during the study) within a recent period of time (90 days or 5 half-lives of...
- Underwent invasive cardiovascular or cerebrovascular procedures within 180 days before screening; or experienced acute heart failure, myocardial...
- History of malignant tumors within 5 years before screening (excluding adequately treated or resected non-metastatic basal or squamous cell skin...
- The patient with SBP ≥ 160 mmHg or DBP ≥ 100 mmHg during screening.
See the full eligibility criteria
- Sign the Informed Consent Form (ICF) before the study, fully understand the contents, process and possible adverse reactions of the study, and be able to follow the contraindications and restrictions specified in this...
- Males and females age ≥ 18 years at the time of informed consent.
- The pregnancy test for β-human chorionic gonadotropin (hCG) must be negative for women of childbearing potential during the screening period and prior to randomization.
- From signing the Informed Consent Form until 3 weeks after the end of treatment, female people of childbearing potential and male people and their partners must agree to use reliable contraceptive measures and not...
- According to the diagnostic criteria and classification of diabetes mellitus issued by the World Health Organization (WHO) in 1999, and the supplementary diagnostic criteria recommended by WHO for diagnosis with...
- Before screening, basal insulin was given once or twice a day. Or Insulin Icodec was given once-weeekly before screening.
- A history of allergy to drugs with two or more mechanisms of action in the past, or known allergies, hypersensitivity, or intolerance to the investigational medicinal product or its excipients.
- people who are pregnant, lactating or planning to become pregnant during the study at screening.
- Participated in any drug clinical study (received non-placebo medication during the study) within a recent period of time (90 days or 5 half-lives of the previous investigational medicinal product, whichever is longer)...
- Underwent invasive cardiovascular or cerebrovascular procedures within 180 days before screening; or experienced acute heart failure, myocardial infarction, stroke, or hospitalization due to angina unstable, transient...
- History of malignant tumors within 5 years before screening (excluding adequately treated or resected non-metastatic basal or squamous cell skin cancer, cervical carcinoma in situ, or prostate cancer in situ) or the...
- The patient with SBP ≥ 160 mmHg or DBP ≥ 100 mmHg during screening.
- people who are unable to comply with the requirements of this protocol as judged by the investigator, or have any other conditions that the investigator considers inappropriate to participate in this study.
The study team makes the final eligibility decision.
Where it's taking place
- Linyi, Shandong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Linyi, Shandong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.