NCT00351546

Brief Summary

Type 2 diabetes results when the body does not produce enough insulin and/or is unable to properly use the insulin it makes (insulin resistance). This study was undertaken to assess the effects of vildagliptin on insulin sensitivity in people with type 2 diabetes.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
12

participants targeted

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

Timeline
Completed

Started Feb 2005

Shorter than P25 for phase_3 diabetes-mellitus-type-2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2005

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2005

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 11, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 13, 2006

Completed
Last Updated

May 7, 2012

Status Verified

May 1, 2012

Enrollment Period

9 months

First QC Date

July 11, 2006

Last Update Submit

May 4, 2012

Conditions

Diabetes Mellitus, Type 2

Keywords

VildagliptinType 2 diabetesInsulin sensitivityInsulin action

Outcome Measures

Primary Outcomes (1)

  • Effect on insulin sensitivity at 6 weeks

Secondary Outcomes (5)

  • Lipolysis rate after 6 weeks of treatment

  • Plasma free fatty acid concentration after 6 weeks of treatment

  • Hepatic glucose production after 6 weeks of treatment

  • Glucose disposal after 6 weeks of treatment

  • Gluconeogenesis rate after 6 weeks of treatment

Interventions

VildagliptinDRUG

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed with type 2 diabetes at least 3 months prior to screening
  • Blood glucose criteria must be met
  • On stable dose of metformin therapy
  • BMI less than or equal to 39

You may not qualify if:

  • Type 1 diabetes, diabetes resulting from pancreatic injury or secondary forms of diabetes
  • Treatment with thiazolidinediones or use of insulin within the previous 3 months
  • Significant illness within 2 weeks prior to dosing
  • High fasting triglycerides as defined by the protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Insulin Resistance

Interventions

Vildagliptin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperinsulinism

Intervention Hierarchy (Ancestors)

NitrilesOrganic ChemicalsPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • David Kelley, MD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 11, 2006

First Posted

July 13, 2006

Study Start

February 1, 2005

Primary Completion

November 1, 2005

Study Completion

December 1, 2005

Last Updated

May 7, 2012

Record last verified: 2012-05