type 2 diabetes
Conditions
Interventions
1.0,2.0,3.0,4.0mg:CJC-1134-PC
Sponsors
The first hospital of Jilin University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects between 18 and70 years of age, female or male; 2. Body Mass Index (BMI) between 20-40kg/m2; 3. According to WHO criteria, diagnose of type 2 diabetes with no treatment; 4. Have stable life style, like diet andexercise at least for a month; 5. FPG =7.0% - <=10%; 7. No clinically significant abnormal findings on the ECG results; 8. If subjects are taking drugs that not involved in exclusion criteria, stable levels of drug should be reached 4 weeks before screening; 9. No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening; 10. Ability to understandandprovide written informed consent andvoluntary consent to participate in the study; 11. No birth plan within 6 months after completed the study.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women; 2. Use of diet pills, OTC drug before screen; 3. Have received oral hypoglycemic drugs; 4. Have received insulin treatment; 5. Have received glucagon peptide 1 (glp-1) analogue or other intestinal promote islet hormone therapy; 6. Have received investigational diabete drug within 30 days before the screen; 7. Systolic blood pressure > 160 MMHG and/or diastolic blood pressure > 100 MMHG; 8. Abnormal serum creatinine levels, or creatinine clearance 4.52mmol/ L (400 mg/dL); 11. Patients with acute pancreatitis, active biliary disease or severe high blood triglycerides. 12.History of medullary thyroid cancer; 13. History of skin squamous cell carcinomas andbasal cell carcinoma tumor history; 14. Have symptoms of cardiac insufficiency; 15. Severe neuropathy, including but not limited to 1) severe autonomic neuropathy (such as body posture low blood pressure or treatment of gastric paralysis) or 2) severe peripheral neuropathy; 16. History of laser treatment of proliferative diabetic retinopathy within 6 months prior to screening; 17. Have symptoms of unstable diabetes complications; 18. Daily use of drugs with a history of gastrointestinal symptoms, such as: high dose of acylsalicylic acid, non-steroidal anti-inflammatory drugs (nsaids), two phosphate; Daily low dose (325 mg or less) ,acetylsalicylic acid is allowed; 19. History of the digestive tract surgery (such as gastric diversion); 20. Use of anticoagulant drugs; 21. A positive hepatitis screen including hepatitis B surface antigen (HBsAg) andhepatitis C/HIV antibody; 22. In the stage of screening or before using research medicine, acute disease occurred; 23. No ability to complete the study in compliance with the protocol; 24. Heavy smokers or alcoholics; 25. Donation or loss of a significant volume of blood or plasma (> 450 mL) within 3 months prior to the initial dose of study medication; 26. Use of any medication known to alter hepatic enzyme activity within 28 days prior to the initial dose of study medication; 27. Use of any Vitamins or herbal products within 14 days prior to receiving study drug; 28. Consumption of alcohol within 24 hours prior to receive study drug; 29. Consumption of any grapefruit or grapefruit-containing juices within 7 days prior to receiving study drug; 30. Consumption of any caffeine-containing foods or beverages within 48 hours prior to receiving study drug; 31. Positive screen of drug andalcohol; 32. History of allergic reaction to CJC - 1134 - PC API or accessories. And the investigators believe that patients are not suitable for participating in the clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| blood pressure; | — |
Countries
China
Contacts
Public ContactYanhua Ding
Outcome results
None listed