Type 2 Diabetes mellitus
Conditions
Interventions
Vildagliptin group:add on vildagliptin 50mg bid
Acarbose group:add on acarbose 50mg tid
Sponsors
The second people's hospital of Shenzhen
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 100 T2DM outpatients or inpatients with poor blood glucose control using the insulin (metformin combined or not combined) therapy in the endocrinology department are collected from Oct 1, 2015 to July 1, 2016. inclusion criteria as following: 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. >= 18 years old; 4. Have applied with various insulins (melbine combined or not combined) of fixed dose before the visit 1, and accepted the treatment for at least 8 weeks with poor blood glucose control (7.0%<=HbA1c <=10%); 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. eGFR<50 mL/min/1.73 m2; 4. 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; 5. 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; 6. Persons with the history of acute or chronic pancreatitis; 7. Have had the malignant tumors including leukemia and lymphoma (excluding preinvasive carcinoma) within the past 5 years; 8. 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; 9. Have applied any known drugs that have common toxic reactions to main organ systems (such as drugs for cell stability) within the past 3 months; 10. Patients who applied other studying drugs within 30 days prior to the 1st visit or within 5 half-life periods of such drugs, whichever is longer, unless a much longer time duration is required by the local medical management department; 11. Persons with the history of active substance abuse (including alcohol) within the last 2 years; 12. Potentially unreliable patients, and those patients who are considered by researchers as unsuitable for this test.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| compare the difference in ?MAGE of the two groups (value of change in MAG before and after treatment); | — |
Secondary
| Measure | Time frame |
|---|---|
| HbA1c;adverse event;insulin dosage;beta cell function;blood pressure;plasma lipids; | — |
Countries
China
Contacts
Public ContactYan Dewen
Outcome results
None listed