Efficacy and Safety of Vildagliptin Added to Continuous Subcutaneous Insulin Infusion in Uncontrolled Type 2 Diabetes
1 other identifier
interventional
400
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jun 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 10, 2018
CompletedStudy Start
First participant enrolled
June 10, 2018
CompletedFirst Posted
Study publicly available on registry
June 20, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 10, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 10, 2019
CompletedJune 20, 2018
June 1, 2018
1 year
June 10, 2018
June 10, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
blood glucose
changes from baseline in FPG and 2hPBG
7 days
Secondary Outcomes (1)
hypoglycemia
7 days
Study Arms (2)
CSII(insulin Lispro)+Vildagliptin
EXPERIMENTALVildagliptin(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)
ACTIVE COMPARATORT2DM 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
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.
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
You may qualify if:
- T2DM
- ≤ age≤70 years old
- BMI 18.0-28.0 Kg/m2
- HbA1c ≥8.5%
- Negtive GAD、ICA、IAA
- Patients do not use antihyperglycemia drugs
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The first afilliated hospital of Xiamen university
Xiamen, Fujian, 361003, China
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 10, 2018
First Posted
June 20, 2018
Study Start
June 10, 2018
Primary Completion
June 10, 2019
Study Completion
December 10, 2019
Last Updated
June 20, 2018
Record last verified: 2018-06