NCT00351832

Brief Summary

This study is not being conducted in the United States. Vildagliptin is an oral antidiabetic agent. This 12-week clinical study is to evaluate the effect of vildagliptin 50mg qd, 50mg bid or 100mg qd compared to placebo 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
236

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 11, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 13, 2006

Completed
Last Updated

May 9, 2007

Status Verified

May 1, 2007

First QC Date

July 11, 2006

Last Update Submit

May 7, 2007

Conditions

Diabetes Mellitus, Type 2

Keywords

Type 2 diabetesVildagliptinHemoglobin A1c

Outcome Measures

Primary Outcomes (1)

  • Change from baseline on HbA1c at 12 weeks

Secondary Outcomes (5)

  • Change from baseline on fasting plasma glucose at 12 weeks

  • Change from baseline on HOMA B at 12 weeks

  • Change from baseline on HOMA IR at 12 weeks

  • Change from baseline in body weight at 12 weeks

  • Change from baseline on fasting lipids at 12 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 dietary therapy/exercise therapy without achievement of glycemic control
  • Outpatients

You may not qualify if:

  • Type 1 diabetes, diabetes that is a result of pancreatic injury, or secondary forms of diabetes
  • Significant cardiovascular disease
  • Significant diabetic complications

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
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 11, 2006

First Posted

July 13, 2006

Study Start

June 1, 2006

Last Updated

May 9, 2007

Record last verified: 2007-05

Locations

JP(1)