NCT01099137

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
344

participants targeted

Target at P75+ for phase_4 diabetes

Timeline
Completed

Started Jan 2010

Longer than P75 for phase_4 diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 5, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 6, 2010

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

May 28, 2014

Status Verified

May 1, 2014

Enrollment Period

2.9 years

First QC Date

April 5, 2010

Last Update Submit

May 26, 2014

Conditions

Diabetes

Keywords

DiabetesVildagliptininsulinC-peptide

Outcome Measures

Primary Outcomes (1)

  • The change of HbA1c

    24weeks

Secondary Outcomes (5)

  • Fasting Plasma Glucose (FPG)

    24 weeks

  • Postprandial Plasma Glucose (PPG)

    24 weeks

  • Hypoglycemia

    24 weeks

  • Body weight

    24 weeks

  • HbA1c < 7.0% without hypoglycemia

    24 weeks

Study Arms (2)

Vildagliptin

EXPERIMENTAL

Vildagliptin will be added to uncontrolled diabetic patients with sulphonylurea and metformin

Drug: Vildagliptin

Sulphonylurea dose-up

ACTIVE COMPARATOR

Sulphonylurea dose will be increased to uncontrolled diabetic patients with sulphonylurea and metformin

Drug: Sulphonylurea dose-up

Interventions

VildagliptinDRUG

Vildagliptin 50mg twice a day, orally, for 24 weeks

Also known as: Galvus
Vildagliptin
Sulphonylurea dose-upDRUG

glimepiride dose will be increased by 50% to uncontrolled diabetic patients with glimepiride and metformin

Also known as: Amaryl
Sulphonylurea dose-up

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam, South Korea

Location

Related Publications (1)

  • Hong AR, Lee J, Ku EJ, Hwangbo Y, Kim KM, Moon JH, Choi SH, Jang HC, Lim S. Comparison of vildagliptin as an add-on therapy and sulfonylurea dose-increasing therapy in patients with inadequately controlled type 2 diabetes using metformin and sulfonylurea (VISUAL study): A randomized trial. Diabetes Res Clin Pract. 2015 Jul;109(1):141-8. doi: 10.1016/j.diabres.2015.04.019. Epub 2015 May 5.

    PMID: 26003889DERIVED

MeSH Terms

Conditions

Diabetes MellitusInsulin Resistance

Interventions

Vildagliptinglimepiride

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperinsulinism

Intervention Hierarchy (Ancestors)

NitrilesOrganic ChemicalsPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Soo Lim, MD,PHD

    Seoul National University Bundang Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 5, 2010

First Posted

April 6, 2010

Study Start

January 1, 2010

Primary Completion

December 1, 2012

Study Completion

May 1, 2013

Last Updated

May 28, 2014

Record last verified: 2014-05

Locations

KR(1)