A Phase 3 Study to Evaluate the Efficacy of JY09 Compared With Dulaglutide in Combination Therapy Diabetes Mellitus Type 2 Patients With Metformin

Launched by BEIJING DONGFANG BIOTECH CO., LTD. · Feb 6, 2024

Keywords

ClinConnect Summary

This clinical trial is testing a new medication called JY09 to see how well it works in controlling blood sugar levels for people with type 2 diabetes who are already taking metformin, a common diabetes medication. The study is comparing two different doses of JY09 with another medication called dulaglutide. It aims to find out which treatment is more effective and safe for managing diabetes.

To participate in this study, individuals need to be between 18 and 75 years old and have been diagnosed with type 2 diabetes for at least 12 weeks. They should be currently taking a stable dose of metformin and have specific blood sugar levels that meet the study's criteria. Participants will receive either JY09 or dulaglutide and will be monitored for their health and how well their blood sugar is controlled. This research is important as it may lead to better treatment options for managing type 2 diabetes. If you or someone you know is interested in joining, it’s a good idea to discuss it with a healthcare provider.

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Eligibility criteria

• Inclusion Criteria:
• • 1. Male or female subjects ≥18 years of age and ≤75 years of age at the time of signing the informed consent form.
• • 2. Those who meet the World Health Organization（WHO）1999 diagnostic criteria for type 2 diabetes mellitus and the WHO Recommendations for the Use of Glycosylated Haemoglobin (HbA1c) for Diagnosis (2011) supplemental diagnostic criteria for a diagnosis of T2DM for ≥ 12 weeks.
• • 3. Received a stable dose of metformin monotherapy with a metformin dose ≥1500 mg/day or a maximally tolerated dose (\<1500 mg/day but ≥1000 mg/day) on the basis of dietary and exercise interventions during the 8 weeks prior to screening.
• • 4. HbA1c ≥7.5% and ≤11.0% at screening (local laboratory) and HbA1c ≥7.0% and ≤10.5% before randomization (V3) (central laboratory).
• • 5. FPG 13.9 mmol/L at screening (local laboratory) and FPG 13.9 mmol/L before randomization (V3) (central laboratory).
• • 6. Body mass index (BMI) ≥18.5 kg/m2 and ≤35.0 kg/m2 at screening and before randomization (V4).
• • 7. Able to understand and willing to sign a written informed consent form (ICF) and comply with the study protocol.
• Exclusion Criteria:
• • 1. People diagnosed with type 1 diabetes or other types of diabetes.
• • 2. Those who have used glucose-lowering drugs other than metformin within 8 weeks prior to screening or prior to randomization (V4), or those who have used drugs that may affect glucose metabolism, such as systemic glucocorticosteroids (except for inhalation or topical topical use) and growth hormone.
• • 3. Those who have used glucose-dependent insulinotropic polypeptide (GIP) and/or glucagon-like peptide-1 (GLP-1) receptor agonists (including single-target, multi-target agonists, and insulin-containing GLP-1 combinations) within 3 months prior to screening.
• • 4. More than 14 days of continuous insulin use in the 6 months prior to screening.
• • 5. Acute complications of diabetes such as diabetic ketoacidosis or hyperglycemic hyperosmolar state within 6 months prior to screening or prior to randomization .
• • 6. Severe chronic complications of diabetes mellitus (e.g., proliferative diabetic retinopathy, severe diabetic neuropathy, diabetic foot, etc.) within 6 months prior to screening, which are assessed by the investigator to be unsuitable for participation in this clinical study.
• • 7. Individuals who have had severe gastrointestinal disease (e.g., active ulcer, gastroparesis, pyloric obstruction, inflammatory bowel disease, etc.) or have undergone gastrointestinal surgery within 6 months prior to screening or prior to randomization or who have been using long-term medications for chronic gastrointestinal disease that have a direct effect on gastrointestinal motility are not suitable for participation in this clinical study, as assessed by the investigator.
• • 8. Other conditions that, in the judgment of the investigator, make the subject unsuitable for participation in this clinical study.