NCT00099931

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
254

participants targeted

Target at P25-P50 for phase_3 diabetes-mellitus-type-2

Timeline
Completed

Started May 2004

Shorter than P25 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

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
5 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
Last Updated

May 7, 2012

Status Verified

May 1, 2012

Enrollment Period

1.1 years

First QC Date

December 21, 2004

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 fasting plasma glucose at 24 weeks

  • Adverse event profile after 24 weeks of treatment

  • Change from baseline in mean daily insulin dose at 24 weeks

  • Change from baseline in mean daily number of insulin injections at 24 weeks

  • Patients with endpoint <7% after 24 weeks

Interventions

vildagliptinDRUG

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Blood glucose criteria must be met
  • On a stable dose of insulin as defined by the protocol
  • Body mass inde (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 Investigative Site

Investigative Sites, Germany

Location

Related Publications (1)

  • Fonseca V, Schweizer A, Albrecht D, Baron MA, Chang I, Dejager S. Addition of vildagliptin to insulin improves glycaemic control in type 2 diabetes. Diabetologia. 2007 Jun;50(6):1148-55. doi: 10.1007/s00125-007-0633-0. Epub 2007 Mar 27.

    PMID: 17387446DERIVED

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

June 1, 2005

Study Completion

June 1, 2005

Last Updated

May 7, 2012

Record last verified: 2012-05

Locations

DE(1)