type 2 diabetes
Conditions
Interventions
Vilda Group:vildagliptin 50mg qd or 50mg bid
control group:any OAD
Sponsors
The Second affiliated hospital of Fujian Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Agree to participate in the test and sign the informed consent form prior to the test; 2. Accordant with the T2DM diagnostic criteria formulated by WHO in 1999; 3. Aged 18 years old and more; 4. Have accepted any anti-hyperglycemic treatment for at least 8 weeks before the visit 1, with inadequate glycemic control (6.5%<HbA1c <8.5%); 5. Male, female without fertility function or female with fertility function but requiring the use of medically-approved and reliable contraceptive methods; 6. Have accepted the diet and exercise therapy, and can keep the diet and exercise therapy during the test, be able to follow all the test requirements.
Exclusion criteria
Exclusion criteria: 1. Patients with type-1 diabetes or secondary diabetes; 2. CHF NYHA III level or above; 3. Acute infection affecting the blood glucose control or other intercurrent diseases affecting the test effect and safety occurred within 4 weeks prior to the visit 1; 4. Have the history of hepatic diseases such as liver cirrhosis, hepatitis B or hepatitis C, or the ALT and AST exceed 2 times the ULN, or the total bilirubin exceeds 2 times the ULN; 5. Persons with the history of acute or chronic pancreatitis; 6. Have had the malignant tumors including leukemia and lymphoma (excluding preinvasive carcinoma) within the past 5 years; 7. Have applied the glucocorticoid for a long time (more than consecutive 7 days) within 4 weeks prior to the 1st visit; have accepted the treatment with growth hormone or similar drugs; 8. Have applied any known drugs that have common toxic reactions to main organ systems (such as drugs for cell stability) within the past 3 moths; 9. Persons with the history of active substance abuse (including alcohol) within the last 2 years.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| After 12 weeks treatment, the proportion of patients having a treatment response: HbA1c =6.5% and no hypoglycaemic event, no discontinuation because of a gastrointestinal (GI) event, or weight gain = 2%; | — |
Secondary
| Measure | Time frame |
|---|---|
| HbA1c;FPG;insulin level;BMI;blood pressure;blood lipid; | — |
Countries
China
Contacts
Public ContactZhou Jingxiong
The Second affiliated hospital of Fujian Medical University
Outcome results
None listed