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[Recruitment of newly-onset type 2 diabetes patients] Recruitment of clinical trial information sharing of newly-onset type 2 diabetes patients Background Information

This study is a randomized, double-blind phase III clinical trial of CJC 1134 PC injection versus placebo initiated by Changshan Kaijiejian Biopharmaceutical Research and Development (Hebei) Co., Ltd. It is planned to enroll 450 patients with type 2 diabetes who have not received diabetes medication and cannot control their blood sugar.
This study was approved by the State Food and Drug Administration (Lot No.: 2015L00497), and has been approved by the team leader’s Peking University People’s Hospital Ethical Review Committee. The risks and benefits of your participation in the study will be guaranteed to the greatest extent. The research drug CJC 1134 PC injection is a long-acting GLP-1 receptor agonist type hypoglycemic drug, which belongs to the national 1.1 category innovative drug. In this study, the study drug was used once a week.

Participant selection criteria

Men or women aged 18-70 (including 18 and 70 years old) at the time of screening; 2. Patients with type 2 diabetes; 3. No anti-diabetic treatment (including oral and injection drugs, or later) within 3 months before screening Chinese herbal medicines for the purpose of sugar, and experimental anti-diabetic products, etc.), and the cumulative use of anti-diabetic drugs for no more than 2 weeks since diagnosis; 4. Have a stable lifestyle before screening, such as eating habits and physical exercise are not obvious Change; 5. Fasting plasma blood glucose ≤13.9mmol/L (250mg/dL); 6. The detection value of glycosylated hemoglobin ≥7.0% and ≤11.0%.
2. The above are part of the standards, and the final standards are controlled by the research doctor and subject to the overall examination results. If you meet the above conditions, you will have the opportunity to participate in this research. Whether to participate depends entirely on your willingness. Even if you decide not to participate in this research, you will not be adversely affected.


Post time: Jun-19-2021