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Tests treatment safety and results for Type 2 Diabetes (T2DM)
Official title Evaluate the Efficacy and Safety of GZR33 Injection in Patients With Type 2 Diabetes
ClinicalTrials.gov ID: NCT07527078
What this study is testing
What is GZR33 Injection?
GZR33 Injection is an investigational medicine, given as an once-daily injection under the skin, being studied as a potential treatment for type 2 diabetes (t2dm).
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
- Evaluate the efficacy of GZR33 Injection and Insulin Degludec Injection (Tresiba®) in Patients with Type 2 Diabetes Mellitus Inadequately Controlled with Oral Antidiabetic Drugs.
- Phase 3: a large, late-stage study
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
- people sign the Informed Consent Form (ICF) before the study, fully understand the contents, process and possible adverse reactions of the study, and...
- Male or female, aged ≥18 years at the time of informed consent..
- Body mass index (BMI) ≥18.5 and ≤35.0 kg/m2 at screening.
- According to the diagnostic criteria and classification of diabetes mellitus issued by the World Health Organization (WHO) in 1999, and the...
- Stable treatment with oral antidiabetic drugs for ≥ 90 days prior to screening.
You likely can't join if
- History of hypersensitivity to ≥ 2 drugs with distinct mechanisms of action, or known hypersensitivity, allergic reactions, or intolerance to the...
- Female people who are pregnant, lactating at screening, or planning a pregnancy during the trial period.
- Confirmed or suspected type 1 diabetes mellitus or specific types of diabetes due to other causes (monogenic diabetes syndrome, cystic...
- Presence of any diseases that may affect HbA1c testing at screening, such as hemolytic anemia, aplastic anemia, hemoglobinopathy, etc., and in the...
- History of severe cardiovascular and cerebrovascular diseases within 180 days prior to screening.
- Significant hepatic or renal dysfunction or active infectious diseases at screening.
See the full eligibility criteria
- people sign the Informed Consent Form (ICF) before the study, fully understand the contents, process and possible adverse reactions of the study, and are able to follow the contraindications and restrictions specified...
- Male or female, aged ≥18 years at the time of informed consent..
- Body mass index (BMI) ≥18.5 and ≤35.0 kg/m2 at screening.
- 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...
- Stable treatment with oral antidiabetic drugs for ≥ 90 days prior to screening.
- History of hypersensitivity to ≥ 2 drugs with distinct mechanisms of action, or known hypersensitivity, allergic reactions, or intolerance to the investigational medicinal products or their excipients (glycerol, phenol...
- Female people who are pregnant, lactating at screening, or planning a pregnancy during the trial period.
- Confirmed or suspected type 1 diabetes mellitus or specific types of diabetes due to other causes (monogenic diabetes syndrome, cystic fibrosis-related diabetes, pancreatitis-induced diabetes, drug- or chemical-induced...
- Presence of any diseases that may affect HbA1c testing at screening, such as hemolytic anemia, aplastic anemia, hemoglobinopathy, etc., and in the investigator's judgment unsuitable for participation; or blood donation...
- History of severe cardiovascular and cerebrovascular diseases within 180 days prior to screening.
- Significant hepatic or renal dysfunction or active infectious diseases at screening.
- Lifestyle (diet, exercise, work circadian rhythm, etc.) expected to change significantly during the trial and affect glycemic control; irregular three-meal intake (e.g., habitual skipping of breakfast); or unwillingness...
- Any other conditions that, in the investigator's judgment, may compromise subject safety or interfere with trial conduct, progress, or outcome.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, 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 Beijing, 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.