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

Xiamen University

Status and phase: Unknown; Phase 4

Conditions: T2DM

Treatments: Drug: CSII+Vildagliptin; Drug: CSII(insulin Lispro)

Study type: Interventional

Funder types: Other

Identifiers

NCT03563794

CSII vs CSII+DPP-4 inhibitor

Details and patient eligibility

About

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

Enrollment: 400 estimated patients

Sex: All

Ages: 30 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 2 patient groups

CSII(insulin Lispro)+Vildagliptin

Experimental group

Description:

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.

Treatment:

Drug: CSII+Vildagliptin

CSII(insulin Lispro)

Active Comparator group

Description:

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.

Treatment:

Drug: CSII(insulin Lispro)