NCT00237237

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 long-term safety and effectiveness of vildagliptin, an unapproved drug, compared to that of pioglitazone in lowering overall blood glucose levels when added to metformin in people with type 2 diabetes not at target blood glucose levels on metformin alone.

Trial Health

85
On Track

Trial Health Score

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

Enrollment
588

participants targeted

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

Geographic Reach
2 countries

2 active sites

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

October 1, 2005

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

October 9, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 12, 2005

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2007

Completed
Last Updated

February 7, 2017

Status Verified

February 1, 2017

Enrollment Period

1.3 years

First QC Date

October 9, 2005

Last Update Submit

February 3, 2017

Conditions

Diabetes Mellitus, Type 2

Keywords

Type 2 diabetesvildagliptin

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in HbA1c at 52 weeks

Secondary Outcomes (5)

  • Adverse event profile after 52 weeks of treatment

  • Change from baseline in fasting plasma glucose at 52 weeks

  • Change from baseline in body weight at 52 weeks

  • Patients with endpoint HbA1c < 7% after 52 weeks

  • Patients with reduction in HbA1c >/= to 7% after 52 weeks

Interventions

vildagliptinDRUG

Eligibility Criteria

Age18 Years - 77 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • History of type 1 diabetes
  • Pregnancy or lactation
  • Evidence of significant diabetic complications
  • Serious cardiovascular events within the past 6 months
  • Laboratory value abnormalities as defined by the protocol
  • Known sensitivity to pioglitazone

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Novartis Pharmaceuticals

East Hanover, New Jersey, 07936, United States

Location

Investigative Centers

Nuremberg, Germany

Location

Related Publications (1)

  • Bolli G, Dotta F, Rochotte E, Cohen SE. Efficacy and tolerability of vildagliptin vs. pioglitazone when added to metformin: a 24-week, randomized, double-blind study. Diabetes Obes Metab. 2008 Jan;10(1):82-90. doi: 10.1111/j.1463-1326.2007.00820.x. Epub 2007 Nov 22.

    PMID: 18034842RESULT

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

October 9, 2005

First Posted

October 12, 2005

Study Start

October 1, 2005

Primary Completion

February 1, 2007

Last Updated

February 7, 2017

Record last verified: 2017-02

Locations

US(1)DE(1)