NCT00325429

Brief Summary

This study is not being conducted in the United States. Vildagliptin is an oral antidiabetic agent. This 52-week clinical study is designed as an open label, long-term study aimed to evaluate the safety of vildagliptin in patients with type 2 diabetes.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at below P25 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

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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

January 7, 2009

Status Verified

January 1, 2009

First QC Date

May 10, 2006

Last Update Submit

January 6, 2009

Conditions

Diabetes Mellitus, Type 2

Keywords

Type 2 diabetesVildagliptinHbA1c

Outcome Measures

Primary Outcomes (1)

  • Adverse events profile after 52 weeks of treatment

Secondary Outcomes (5)

  • Change from baseline to endpoint on HbA1c at 52 weeks

  • Change from baseline to endpoint on fasting plasma glucose at 52 weeks

  • Change from baseline to endpoint in HOMA B at 52 weeks

  • Change from baseline to endpoint in HOMA IR at 52 weeks

  • Change from baseline to endpoint in body weight at 52 weeks

Interventions

VildagliptinDRUG

Eligibility Criteria

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

You may qualify if:

  • Diagnosis of type 2 diabetes
  • Patients who have been placed on diet and exercise therapy without achieving 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

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
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 10, 2006

First Posted

May 12, 2006

Study Start

April 1, 2006

Last Updated

January 7, 2009

Record last verified: 2009-01

Locations

JP(1)