Effect of Vildagliptin in Type 2 Diabetes Treated With Sulphonylurea and Metformin

May 26, 2014 updated by: Soo Lim, Seoul National University Bundang Hospital

The Study About Glucose Lowering Effect of Vildagliptin in Type 2 Diabetes Patients Who Are Uncontrolled With Metformin and a Sulphonylurea

Dual combination therapy with metformin and sulphonylurea is the most commonly used combination regimen to treat patients with type 2 diabetes. But, treatment with the dual combination therapy is often unsuccessful at achieving glycaemic control in patients with type 2 diabetes. In this setting, use of insulin is often the next therapeutic step.

Recently, dipeptidyl peptidase (DPP)-IV inhibitor is increasingly being used in clinical practice. It is well established that DPP-IV inhibitor improve glycemic control in patients with type 2 diabetes.

But, there have been few studies about the glucose lowering effect of DPP-IV inhibitors (vildagliptin) in Type 2 diabetes patients on the dual combination therapy with a sulfonylurea agent and metformin.The researchers hypothesized that DPP-IV inhibitor as add-on therapy to combination of a sulfonylurea agent and metformin have favorable glucose lowering effect in type 2 diabetic patients. The researchers plan to investigate the change in HbA1C and fasting glucose of 24 weeks treatment with vildagliptin (DPP-IV inhibitor) in combination with a sulfonylurea agent and metformin in type 2 diabetic patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

344

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 Locations

  • Korea, Republic of
      • Seongnam, Korea, Republic of
        • Seoul National University Bundang Hospital

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

18 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Type 2 diabetes
  • HbA1c ≥ 7%
  • Age ≥ 18

Exclusion Criteria:

  • Contraindication to Vildagliptin
  • Pregnant or breast feeding women
  • Type 1 diabetes, gestational diabetes, or diabetes with secondary cause
  • Chronic hepatitis B or C (except healthy carrier of HBV)
  • Liver disease (AST/ALT > 3-fold the upper limit of normal)
  • Renal failure (Cr > 2.0)
  • Cancer within 5 years
  • Not appropriate for oral antidiabetic agent
  • Medication which affect glycemic control
  • Disease which affect efficacy and safety of drugs
  • Other clinical trial within 30 days

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: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Vildagliptin
Vildagliptin will be added to uncontrolled diabetic patients with sulphonylurea and metformin
Drug: Vildagliptin
Vildagliptin 50mg twice a day, orally, for 24 weeks
Other Names:
  • Galvus
ACTIVE_COMPARATOR: Sulphonylurea dose-up
Sulphonylurea dose will be increased to uncontrolled diabetic patients with sulphonylurea and metformin
Drug: Sulphonylurea dose-up
glimepiride dose will be increased by 50% to uncontrolled diabetic patients with glimepiride and metformin
Other Names:
  • Amaryl

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The change of HbA1c
Time Frame: 24weeks
24weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Fasting Plasma Glucose (FPG)
Time Frame: 24 weeks
24 weeks
Postprandial Plasma Glucose (PPG)
Time Frame: 24 weeks
24 weeks
Hypoglycemia
Time Frame: 24 weeks
24 weeks
Body weight
Time Frame: 24 weeks
24 weeks
HbA1c < 7.0% without hypoglycemia
Time Frame: 24 weeks
24 weeks

Collaborators and Investigators

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

Sponsor

Seoul National University Bundang Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

January 1, 2010

Primary Completion (ACTUAL)

December 1, 2012

Study Completion (ACTUAL)

May 1, 2013

Study Registration Dates

First Submitted

April 5, 2010

First Submitted That Met QC Criteria

April 5, 2010

First Posted (ESTIMATE)

April 6, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

May 28, 2014

Last Update Submitted That Met QC Criteria

May 26, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SNUBH_ENDO3

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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