Type 2 diabetes mellitus
Conditions
Interventions
Byetta:Byetta
Sponsors
Peking University Third Hospital
Eligibility
Sex/Gender
All
Age
20 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. To be aged 20 to 70 years; 2. Diagnosis of type 2 diabetes for more than 1 year; 3. Treated with metformin/insulin secretagogue alone or in combination at a stable dosage for at least 3 months; 4. Without exposure to insulin, TZDs, GLP-1R agonist, DPP-4 inhibitor,alpha-Glucosidase during the last 3 months, or exposured to the above medication less than 7 days; 5. HbA1c concentration to be 7% to 10%; 6. Fasting blood glucose concentration to be 7mmol/L to 13.9mmol/L; 7. BMI ratio to be 22kg/m2 to 40kg/m2; 8. Agreed to sign the informed consent file before screening; 9. Agreed to adhere the project (including SMBG and filling the patient follow-up diary.
Exclusion criteria
Exclusion criteria: 1. Histories of diabetic ketoacidosis or diabetic hyperosmolar attact; 2. Histories of severe hypoglycemia coma or frequent hypoglycemia (1 times/week) within 3 months before enrollment; 3. The 2-h blood glucose (BG) of standard meal test or one point of the 7-point SMBG (premeal and postprandial and bed time) is less than or equal to 4.4mmol/L; 4. Progressive diabetic retinopathy (proliferative phase), or macular edema that may need to have laser and other ophthalmological treatment during the study; 5. Untreated or poorly controlled hypertension, SBP >=180mmHg or DBP >=100mmHg; 6. Abnormalities in the following laboratory tests: Blood amylase and / or lipase >3 times the upper limit of local laboratory normal values Hb=5.6 mmol/L); 8. Histories of persistent nausea, vomiting and other gastrointestinal symptoms, or stomach paralysis, uncontrolled gastroesophageal reflux disease, uncontrolled gastric ulcer within 6 months before enrollment; 9. Renal dysfunction, not only limited to: serum creatinine >=1.5mg/dL (133 mol/L) for male >=1.4 mg/dl (124 mol/L) for female; 10. Affected by multiple endocrine neoplasia type 2A or type 2B or with family history of medullary thyroid carcinoma; 11. History of hemoglobulin disease or hemolytic anemia, or had blood donation or transfusion within 3 months before the enrollment; 12. History of treatment for weight control or weight change over 5kg for the last 3 months before enrollment; 13. Systemic steroid therapy (not including focal or inhalation treatment) more than 7 days within 3 months before enrollment; 14. Currently is receiving monoamine oxidase inhibitor treatment; 15. History of strokes, myocardial infarction, angina pectoris, congestive heart failure, coronary bypass operation, percutaneous coronary angioplasty and percutaneous coronary angioplasty within 1 year befrore enrollment; 16. An uncontrolled malignancy within 1 year before enrollment; 17. Companied with serious diseases, including disease of cardiovascular system, liver, nervous system, endocrine system, or other systems, and that lead to the uncompletement of the study or affect the judgment of the study result; 18. Women of childbearing age (WOCBP. Has experience menarche, and did not take the uterus resection and bilateral fallopian tube ligation or bilateral oophorectomy, non postmenopausal women) are unwilling or unable to adopt an effective method of contraception. Menopause refers to no other reasons under the condition of not less than 12 consecutive months without menstruation. Effective contraceptive measures including oral contraceptives, the use of other hormonal contraceptives or mechanical contraceptive measures; 19. an experimental drug and / or a positive control drug was received within the first 3 months of the entry into the group; 20. pregnant or lactating women; 21. there are cases of obstruction of the patient's compliance and completion of the study programme (known as the drug and alcohol abuse, psychosis, etc.); 22. the patient's past allergies to this product; 23. in the screening of patients with adverse events, according to the researchers estimate is not suitable in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HbA1c; | — |
Secondary
| Measure | Time frame |
|---|---|
| percentage of HbA1c <7%;Fasting blood glucose;Seven point glucose spectrum;Post Prandial blood glucose;weight; | — |
Countries
China
Contacts
Public ContactTianpei Hong
Outcome results
None listed