Type 2 diabetes
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. newly-diagnosed type 2 diabetic patients, drug naive; 2. age 30~70 years; 3. HbA1c 7.0-10.0%; 4. BMI 20~35 kg/m2, stable body weight (<=10% variation) for at least 3 months prior to screening; 5. female patients of reproductive age should practice a reliable method of birth control throughout the study.
Exclusion criteria
Exclusion criteria: 1. acute or severe chronic diabetic complications; 2. congestive heart failure (NYHA grade III-IV); 3. severe gastrointestinal disease; 4. severe osteoporosis or history of pathological fracture, or use of bisphosphonates preparation; 5. other severe intercurrent illness; 6. serum aminotransferase (ALT and AST) level higher than 2 times of the upper normal limits and/or serum creatinie>=133umol/L (1.5mg/dL); 7. tested positive for glutamic acid decarboxylase antibody; 8. use of weight loss drugs, corticosteroids, drugs known to affect gastrointestinal motility, transplantation medications, or any investigational drug; 9. history of pancreatitis; 10. serum triglyceride >=5.0 mmol/L; 11. pregnancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Glycemic control, as assessed by HbA1; | — |
Secondary
| Measure | Time frame |
|---|---|
| (2)beta-cell function (first-phase insulin response;early-phase and late-phase insulin response;(1) Percentage of patients achieving HbA1c <=6.5% and effect of different interventions on fasting; | — |
Countries
China