A Study to Assess the Acute Effects of Vildagliptin on Ga... | NCT00380380

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

NCT00380380

Sponsor

Novartis

Status

Completed

Last Update Posted

Feb 23, 2017Actual

Enrollment

Phase

Phase 3

Conditions

Diabetes Mellitus, Type 2

Interventions

Vildagliptin

Countries

Germany

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

Feb 2017

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

Jan 2006

Primary Completion Date

Nov 2006Actual

Completion Date

Nov 2006Actual

First Submitted Date

Sep 22, 2006

First Submission Date that Met QC Criteria

Sep 22, 2006

First Posted Date

Sep 26, 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

Feb 20, 2017

Last Update Posted Date

Feb 23, 2017Actual

Description Module

Brief Summary

Please note this study is not being conducted in the United States. The purpose of this study is to assess the acute effects of vildagliptin, an unapproved drug, in reducing post-meal glucose levels by delaying gastric emptying.

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

Name	Type	Description	Arm Group Labels	Other Names
Vildagliptin	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Evaluate the effects of acute effects of vildagliptin on gastric emptying

Secondary Outcomes

Measure	Description	Time Frame
Effect on steady state levels of active GLP-1 and GIP
Change in fasting and postprandial glucose levels.
Change in glucagon secretion

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Must be able to complete a 1-week wash-out of current anti-diabetic medications
Cannot take any medications which may alter gastric motility except for cardiac medication at a stable dose
Blood glucose criteria must be met
BMI <40

Exclusion Criteria:

History of type 1 diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes
Need for insulin within 3 months or patients on thiazolidinediones
Significant concommitant disease or complications of diabetes
Patients with any history of gastrointestinal surgery or positive gastrointestinal symptons
Abnormal liver function tests as defined by the protocol
Other protocol-defined inclusion/exclusion criteria may apply

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 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
Novartis Pharmaceuticals	Novartis Pharmaceuticals	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Munich, 81377, Germany		Munich			Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17303799	Result	Vella A, Bock G, Giesler PD, Burton DB, Serra DB, Saylan ML, Dunning BE, Foley JE, Rizza RA, Camilleri M. Effects of dipeptidyl peptidase-4 inhibition on gastrointestinal function, meal appearance, and glucose metabolism in type 2 diabetes. Diabetes. 2007 May;56(5):1475-80. doi: 10.2337/db07-0136. Epub 2007 Feb 15.

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