T2DM
Conditions
Brief summary
The randomized, controlled clinical trial investigate the efficacy and safety of vildagliptin added to continuous subcutaneous insulin infusion in uncontrolled type 2 diabetes
Interventions
DRUGCSII+Vildagliptin
Vildagliptin(50mg b.i.d po.) will be added to Continuous Subcutaneous Insulin Infusion(insulin Lispro) treatment in T2DM. Doses of insulin Lispro will be instructed on a titration schedule, adjusted every 2 days.
DRUGCSII(insulin Lispro)
T2DM patients will receive Continuous Subcutaneous Insulin Infusion(insulin Lispro) treatment. Doses of insulin Lispro will be instructed on a titration schedule, adjusted every 2 days.
Sponsors
The First Affiliated Hospital of Xiamen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* T2DM * 30≤ age≤70 years old * BMI 18.0-28.0 Kg/m2 * HbA1c ≥8.5% * Negtive GAD、ICA、IAA * Patients do not use antihyperglycemia drugs * Patients use antihyperglycemia drugs for ≥8 weeks(exclusion of DPP-4 inhibitors and GLP-1 receptor agonist)
Exclusion criteria
* T1DM,GDM * Congestive heart failure (New York Heart Association Functional Classification III-IV) * ALT or AST\> 2 times above normal,GFR \<50ml/min * Severe infection in the previous 3 months * Severely acute or chronic diabetic complications * Patients who were taking medications,known to affect glycaemic control, such as glucocorticoids(aside from antidiabetic medications) * History of pancreatitis * Trauma or patients operating at a scheduled time * Any mental health condition
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| blood glucose | 7 days | changes from baseline in FPG and 2hPBG |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| hypoglycemia | 7 days | frequancy of hypoglycemia |
Countries
China
Contacts
Primary ContactXiulin Shi, MD
Outcome results
None listed