NCT00351507

Brief Summary

This study was designed to directly assess the effects of vildagliptin on gastric emptying in people with type 2 diabetes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

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

Timeline
Completed

Started May 2005

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, 2005

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2006

Completed
5 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 diabetes

Outcome Measures

Primary Outcomes (1)

  • Effect on gastric emptying

Secondary Outcomes (3)

  • Effect on gastric volume

  • Effect on satiety

  • Effect on endogenous glucose appearance, glucose appearance and glucose disposal

Interventions

VildagliptinDRUG

Eligibility Criteria

Age35 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
  • Blood glucose criteria must be met
  • BMI in the range 22-40

You may not qualify if:

  • History of type 1 diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes
  • Use of thiazolidinediones or need for insulin within 3 months prior to screening
  • Significant concomitant diseases or complications of diabetes
  • High fasting triglycerides as defined by the protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

  • Dalla Man C, Bock G, Giesler PD, Serra DB, Ligueros Saylan M, Foley JE, Camilleri M, Toffolo G, Cobelli C, Rizza RA, Vella A. Dipeptidyl peptidase-4 inhibition by vildagliptin and the effect on insulin secretion and action in response to meal ingestion in type 2 diabetes. Diabetes Care. 2009 Jan;32(1):14-8. doi: 10.2337/dc08-1512. Epub 2008 Oct 17.

    PMID: 18931099DERIVED

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

  • Adrian Vella, MD

    Mayo Clinic & Foundation

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

July 11, 2006

First Posted

July 13, 2006

Study Start

May 1, 2005

Primary Completion

February 1, 2006

Study Completion

February 1, 2006

Last Updated

May 7, 2012

Record last verified: 2012-05

Locations

US(1)