NCT00238498

Brief Summary

This study was not conducted in the United States. The purpose of this study was to assess the safety and effectiveness of a number of doses of vildagliptin, an unapproved drug, in the treatment of people with type 2 diabetes.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
291

participants targeted

Target at P75+ for phase_2 diabetes-mellitus-type-2

Timeline
Completed

Started Jul 2004

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

July 1, 2004

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 12, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 13, 2005

Completed
Last Updated

May 2, 2012

Status Verified

April 1, 2012

Enrollment Period

11 months

First QC Date

October 12, 2005

Last Update Submit

April 30, 2012

Conditions

Diabetes Mellitus, Type 2

Keywords

Type 2 diabetesvildagliptinHbA1c

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in HbA1c at 12 weeks

Secondary Outcomes (5)

  • Change from baseline for postprandial glucose at 12 weeks

  • Change from baseline on fasting plasma glucose at 12 weeks

  • Change from baseline on postprandial glucose AUC at 12 weeks

  • Change from baseline in HOMA B at 12 weeks

  • Change from baseline in HOMA IR at 12 weeks

Interventions

vildagliptinDRUG

Eligibility Criteria

Age20 Years - 75 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 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 diseases
  • Significant diabetic complications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 12, 2005

First Posted

October 13, 2005

Study Start

July 1, 2004

Primary Completion

June 1, 2005

Study Completion

June 1, 2005

Last Updated

May 2, 2012

Record last verified: 2012-04