NCT00325117

Brief Summary

This study is not being conducted in the United States. Vildagliptin is an oral antidiabetic agent. This 12-week clinical study is designed as a multicenter, randomized, double-blind, parallel-group, placebo-controlled study aimed to evaluate the efficacy and safety of vildagliptin as add-on therapy to a sulfonylurea in patients with type 2 diabetes inadequately controlled with sulfonylurea monotherapy.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P25-P50 for phase_3 diabetes-mellitus-type-2

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

April 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 10, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 12, 2006

Completed
Last Updated

May 14, 2007

Status Verified

May 1, 2007

First QC Date

May 10, 2006

Last Update Submit

May 10, 2007

Conditions

Diabetes Mellitus, Type 2

Keywords

Type 2 diabetesVildagliptinHbA1c

Outcome Measures

Primary Outcomes (1)

  • Change from baseline to endpoint on HbA1c at 12 weeks

Secondary Outcomes (5)

  • Change from baseline to endpoint on fasting plasma glucose at 12 weeks

  • Change from baseline to endpoint in HOMA B at 12 weeks

  • Change from baseline to endpoint in HOMA IR at 12 weeks

  • Change from baseline to endpoint on fasting lipids at 12 weeks

  • Adverse events profile after 12 weeks of treatment

Interventions

VildagliptinDRUG

Eligibility Criteria

Age20 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of type 2 diabetes and treated with a stable dose of sulfonylurea
  • Patients on diet and exercise who have not reached target blood glucose levels
  • Outpatients

You may not qualify if:

  • Type 1 diabetes, diabetes that is a result of pancreatic injury, or secondary forms of diabetes
  • Significant cardiovascular complications as defined by the protocol
  • Significant diabetic complications as defined by the protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novartis Pharmaceuticals

Tokyo, Japan

Location

Related Publications (1)

  • Kikuchi M, Haneda M, Koya D, Tobe K, Onishi Y, Couturier A, Mimori N, Inaba Y, Goodman M. Efficacy and tolerability of vildagliptin as an add-on to glimepiride in Japanese patients with Type 2 diabetes mellitus. Diabetes Res Clin Pract. 2010 Sep;89(3):216-23. doi: 10.1016/j.diabres.2010.04.017.

    PMID: 20537746DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Vildagliptin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

NitrilesOrganic ChemicalsPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 10, 2006

First Posted

May 12, 2006

Study Start

April 1, 2006

Last Updated

May 14, 2007

Record last verified: 2007-05

Locations

JP(1)