NCT00110240

Brief Summary

This study is not being conducted in the United States. The purpose of this study is to assess the safety and effectiveness of vildagliptin, an unapproved drug, compared to acarbose in lowering overall blood glucose levels in people with type 2 diabetes who have not been previously treated with drug therapy to lower their blood sugar.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
594

participants targeted

Target at P50-P75 for phase_3 diabetes-mellitus-type-2

Timeline
Completed

Started Apr 2005

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, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 4, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 5, 2005

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2006

Completed
Last Updated

May 7, 2012

Status Verified

May 1, 2012

Enrollment Period

1.5 years

First QC Date

May 4, 2005

Last Update Submit

May 4, 2012

Conditions

Diabetes Mellitus, Type 2

Keywords

Type 2 diabetesvildagliptin

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in HbA1c at 24 weeks

Secondary Outcomes (5)

  • Change from baseline in HbA1c at 24 weeks for subset of Chinese patients

  • Overall adverse event profile after 24 weeks of treatment

  • Gastrointestinal side effect profiles after 24 weeks of treatment

  • Change from baseline in fasting plasma glucose at 24 weeks

  • Patients with endpoint HbA1c <7% after 24 weeks

Interventions

vildagliptinDRUG

Eligibility Criteria

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

You may qualify if:

  • Not currently on drug therapy for type 2 diabetes
  • Body mass index (BMI) in the range 20-40
  • Blood glucose criteria must be met

You may not qualify if:

  • Pregnancy or lactation
  • Type 1 diabetes
  • Evidence of significant diabetic complications
  • Evidence of serious cardiovascular conditions
  • Laboratory value abnormalities as defined by the protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novartis Pharmaceuticals

Basel, Switzerland

Location

Related Publications (1)

  • Pan C, Yang W, Barona JP, Wang Y, Niggli M, Mohideen P, Wang Y, Foley JE. Comparison of vildagliptin and acarbose monotherapy in patients with Type 2 diabetes: a 24-week, double-blind, randomized trial. Diabet Med. 2008 Apr;25(4):435-41. doi: 10.1111/j.1464-5491.2008.02391.x. Epub 2008 Mar 13.

    PMID: 18341596DERIVED

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
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 4, 2005

First Posted

May 5, 2005

Study Start

April 1, 2005

Primary Completion

October 1, 2006

Study Completion

October 1, 2006

Last Updated

May 7, 2012

Record last verified: 2012-05

Locations

CH(1)