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

Phase 4

• Conditions: T2DM
• Interventions: Drug: CSII+Vildagliptin; Drug: CSII(insulin Lispro)

• Registration Number: NCT03563794
• Lead Sponsor: The First Affiliated Hospital of Xiamen University

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2018-06
• Study Start: 2018-06-10
• Study First Submitted: 2018-06-10
• Study First Submitted QC: 2018-06-10
• Last Update Submitted: 2018-06-10
• Study First Posted: 2018-06-20
• Last Update Posted: 2018-06-20
• Primary Completion: 2019-06-10
• Study Completion: 2019-12-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CSII(insulin Lispro)+Vildagliptin	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)	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.

Primary Outcome Measures

Name	Time	Method
blood glucose	7 days	changes from baseline in FPG and 2hPBG

Secondary Outcome Measures

Name	Time	Method
hypoglycemia	7 days	frequancy of hypoglycemia

Trial Locations

Locations (1)

The first afilliated hospital of Xiamen university; 🇨🇳 Xiamen, Fujian, China