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

• Status: Unknown status
• Trial end date: 2019-12-10
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The First Affiliated Hospital of Xiamen University
• Treatments: Insulin; Insulin Lispro; Insulin, Globin Zinc; Vildagliptin

Criteria

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