NCT00351585

Brief Summary

Type 2 diabetes results when the body does not produce enough insulin to regulate blood sugar. This study is designed to measure the effect of vildagliptin on the maximum insulin secretion by the pancreas.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
39

participants targeted

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

Timeline
Completed

Started Jul 2004

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

July 1, 2004

Completed
1.2 years 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
10 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

1.2 years

First QC Date

July 11, 2006

Last Update Submit

May 4, 2012

Conditions

Diabetes Mellitus, Type 2

Keywords

VildagliptinType 2 diabetesInsulin secretionBeta cell

Outcome Measures

Primary Outcomes (2)

  • Change from baseline in maximal insulin secretory capacity at 12 weeks

  • Durability of this effect after a 2-week washout

Secondary Outcomes (3)

  • Change from baseline in beta-cell sensitivity to glucose at 12 weeks

  • Durability of this effect after a 2-week washout

  • Chance from baseline in glucagon secretion at 12 weeks

Interventions

VildagliptinDRUG

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed with type 2 diabetes for at least 6 months
  • Patients whose diabetes is controlled by diet and exercise only or patients taking metformin
  • BMI in the range 22-45
  • Blood glucose criteria must be met

You may not qualify if:

  • Pregnancy or lactation
  • Type 1 diabetes or diabetes resulting from pancreatic injury
  • Cardiovascular complications as defined by the protocol
  • Significant diabetic complications as defined by the protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • D'Alessio DA, Denney AM, Hermiller LM, Prigeon RL, Martin JM, Tharp WG, Saylan ML, He Y, Dunning BE, Foley JE, Pratley RE. Treatment with the dipeptidyl peptidase-4 inhibitor vildagliptin improves fasting islet-cell function in subjects with type 2 diabetes. J Clin Endocrinol Metab. 2009 Jan;94(1):81-8. doi: 10.1210/jc.2008-1135. Epub 2008 Oct 28.

    PMID: 18957505DERIVED

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

  • David D'Alessio, MD

    University of Cincinnati

    PRINCIPAL INVESTIGATOR

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

July 11, 2006

First Posted

July 13, 2006

Study Start

July 1, 2004

Primary Completion

September 1, 2005

Study Completion

September 1, 2005

Last Updated

May 7, 2012

Record last verified: 2012-05