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

June 10, 2018 updated by: The First Affiliated Hospital of Xiamen University
The randomized, controlled clinical trial investigate the efficacy and safety of vildagliptin added to continuous subcutaneous insulin infusion in uncontrolled type 2 diabetes

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

400

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Fujian
      • Xiamen, Fujian, China, 361003
        • Recruiting
        • The first afilliated hospital of Xiamen university
        • Contact:
        • Principal Investigator:
          • Xue-jun Li, MD,PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: CSII(insulin Lispro)+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.
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.
ACTIVE_COMPARATOR: 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.
Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
blood glucose
Time Frame: 7 days
changes from baseline in FPG and 2hPBG
7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
hypoglycemia
Time Frame: 7 days
frequancy of hypoglycemia
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital of Xiamen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

June 10, 2018

Primary Completion (ANTICIPATED)

June 10, 2019

Study Completion (ANTICIPATED)

December 10, 2019

Study Registration Dates

First Submitted

June 10, 2018

First Submitted That Met QC Criteria

June 10, 2018

First Posted (ACTUAL)

June 20, 2018

Study Record Updates

Last Update Posted (ACTUAL)

June 20, 2018

Last Update Submitted That Met QC Criteria

June 10, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSII vs CSII+DPP-4 inhibitor

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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