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

NCT ID: NCT00380380

Last Updated: 2017-02-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2006-11-30

Brief Summary

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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

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Interventions

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Vildagliptin

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Munich, 81377, Germany

Munich, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type RESULT
PMID: 17303799 (View on PubMed)

Other Identifiers

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CLAF237A2378

Identifier Type: -

Identifier Source: org_study_id

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