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

Sponsor
Seoul National University Bundang Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT01099137
Collaborator
(none)
344
Enrollment
1
Location
2
Arms
40
Duration (Months)
8.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
344 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
The Study About Glucose Lowering Effect of Vildagliptin in Type 2 Diabetes Patients Who Are Uncontrolled With Metformin and a Sulphonylurea
Study Start Date :
Jan 1, 2010
Actual Primary Completion Date :
Dec 1, 2012
Actual Study Completion Date :
May 1, 2013

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. The change of HbA1c [24weeks]

    Secondary Outcome Measures

    1. Fasting Plasma Glucose (FPG) [24 weeks]

    2. Postprandial Plasma Glucose (PPG) [24 weeks]

    3. Hypoglycemia [24 weeks]

    4. Body weight [24 weeks]

    5. HbA1c < 7.0% without hypoglycemia [24 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Seoul National University Bundang Hospital Seongnam Korea, Republic of

    Sponsors and Collaborators

    • Seoul National University Bundang Hospital

    Investigators

    • Principal Investigator: Soo Lim, MD,PHD, Seoul National University Bundang Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Soo Lim, Professor, Seoul National University Bundang Hospital
    ClinicalTrials.gov Identifier:
    NCT01099137
    Other Study ID Numbers:
    • SNUBH_ENDO3
    First Posted:
    Apr 6, 2010
    Last Update Posted:
    May 28, 2014
    Last Verified:
    May 1, 2014
    Keywords provided by Soo Lim, Professor, Seoul National University Bundang Hospital
    Diabetes
    Vildagliptin
    insulin
    C-peptide
    Additional relevant MeSH terms:
    Diabetes Mellitus
    Vildagliptin

    Study Results

    No Results Posted as of May 28, 2014