A Study to Assess the Effects of Vildagliptin on Gastric... | NCT00351507

Studies
A Study to Assess the Effects of Vildagliptin on Gastric Emptying in Patients With Type 2 Diabetes

NCT00351507

Sponsor

Novartis Pharmaceuticals

Status

Completed

Last Update Posted

May 7, 2012Estimated

Enrollment

10Actual

Phase

Phase 3

Conditions

Diabetes Mellitus, Type 2

Interventions

Vildagliptin

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2005

Primary Completion Date

Feb 2006Actual

Completion Date

Feb 2006Actual

First Submitted Date

Jul 11, 2006

First Submission Date that Met QC Criteria

Jul 11, 2006

First Posted Date

Jul 13, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 4, 2012

Last Update Posted Date

May 7, 2012Estimated

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Name	Type	Description	Arm Group Labels	Other Names
Vildagliptin	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Effect on gastric emptying

Secondary Outcomes

Measure	Description	Time Frame
Effect on gastric volume
Effect on satiety
Effect on endogenous glucose appearance, glucose appearance and glucose disposal

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosed with type 2 diabetes for at least 6 months
Blood glucose criteria must be met
BMI in the range 22-40

Exclusion Criteria:

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

Other protocol-defined inclusion/exclusion criteria may apply

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

35 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Adrian Vella, MD	Mayo Clinic & Foundation	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mayo Clinic		Rochester	Minnesota	55905	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
18931099	Derived	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.

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

ID	Term
D009570	Nitriles
D009930	Organic Chemicals
D011759	Pyrrolidines
D006573	Heterocyclic Compounds, 1-Ring