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

T2DM Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03563794
• Other study ID #: CSII vs CSII+DPP-4 inhibitor
• Status: Recruiting
• Phase: Phase 4
• Start date: June 10, 2018
• Est. completion date: December 10, 2019

Study information

• Verified date: June 2018
• Source: The First Affiliated Hospital of Xiamen University
• Contact: Xiulin Shi, MD
• Phone: 13959284763
• Email: shixiulin2002[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 10, 2019
• Est. primary completion date: June 10, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• T2DM

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
China	The first afilliated hospital of Xiamen university	Xiamen	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Xiamen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	blood glucose	changes from baseline in FPG and 2hPBG	7 days
Secondary	hypoglycemia	frequancy of hypoglycemia	7 days