NCT00099892

Brief Summary

Many people with type 2 diabetes cannot maintain target blood glucose levels when taking a single oral drug. The purpose of this study is to assess the safety and effectiveness of two doses of vildagliptin, an unapproved drug, when added to metformin in people with type 2 diabetes who are not at target blood glucose levels on metformin alone.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
544

participants targeted

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

Timeline
Completed

Started May 2004

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

May 1, 2004

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

December 21, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 22, 2004

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2005

Completed
Last Updated

August 2, 2017

Status Verified

July 1, 2017

Enrollment Period

1.3 years

First QC Date

December 21, 2004

Last Update Submit

July 31, 2017

Conditions

Diabetes Mellitus, Type 2

Keywords

type 2 diabetesvildagliptin

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in HbA1c after 24 weeks

Secondary Outcomes (5)

  • Change from baseline in fasting plasma glucose at 24 weeks

  • Patients with endpoint HbA1c <7% after 24 weeks

  • Patients with reduction in HbA1c >/=to 0.7% after 24 weeks

  • Change from baseline in body weight at 24 weeks

  • Change from baseline in fasting lipids at 24 weeks

Interventions

vildagliptinDRUG

Eligibility Criteria

Age18 Years - 78 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Blood glucose criteria must be met
  • On a stable dose of metformin as defined by the protocol
  • Body mass index (BMI) in the range 22-45

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novartis Pharmaceuticals

East Hanover, New Jersey, 07936, United States

Location

Related Publications (1)

  • Bosi E, Camisasca RP, Collober C, Rochotte E, Garber AJ. Effects of vildagliptin on glucose control over 24 weeks in patients with type 2 diabetes inadequately controlled with metformin. Diabetes Care. 2007 Apr;30(4):890-5. doi: 10.2337/dc06-1732. Epub 2007 Feb 2.

    PMID: 17277036DERIVED

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

December 21, 2004

First Posted

December 22, 2004

Study Start

May 1, 2004

Primary Completion

September 1, 2005

Study Completion

September 1, 2005

Last Updated

August 2, 2017

Record last verified: 2017-07

Locations

US(1)