Efficacy and Safety of Vildagliptin Added to Continuous Subcutaneous Insulin Infusion in Uncontrolled Type 2 Diabetes

Study Overview
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Brief Summary
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The randomized, controlled clinical trial investigate the efficacy and safety of vildagliptin added to continuous subcutaneous insulin infusion in uncontrolled type 2 diabetes

Official Title
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Efficacy and Safety of Vildagliptin Added to Continuous Subcutaneous Insulin Infusion in Uncontrolled Type 2 Diabetes

Conditions
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T2DM

Intervention / Treatment
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* Drug: CSII+Vildagliptin
* Drug: CSII(insulin Lispro)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CSII(insulin Lispro)+Vildagliptin<br>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. | Drug: CSII+Vildagliptin<br>* 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.<br>|
| Active Comparator: CSII(insulin Lispro)<br>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. | Drug: CSII(insulin Lispro)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood glucose | changes from baseline in FPG and 2hPBG | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hypoglycemia | frequancy of hypoglycemia | 7 days |