Efficacy and Safety of Vildagliptin Added to Continuous Subcutaneous Insulin Infusion in Uncontrolled Type 2 Diabetes
NCT ID: NCT03563794
Last Updated: 2018-06-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
400 participants
INTERVENTIONAL
2018-06-10
2019-12-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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CSII(insulin Lispro)+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.
CSII+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.
CSII(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.
CSII(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.
Interventions
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CSII+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.
CSII(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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
30 Years
70 Years
ALL
No
Sponsors
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The First Affiliated Hospital of Xiamen University
OTHER
Responsible Party
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Locations
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The first afilliated hospital of Xiamen university
Xiamen, Fujian, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CSII vs CSII+DPP-4 inhibitor
Identifier Type: -
Identifier Source: org_study_id
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