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

February 20, 2017 updated by: Novartis

A Randomized, Single-blind, Placebo Controlled, Cross-over Study to Evaluate the Acute Effects of Vildagliptin on Gastric Emptying in Patients With Type 2 Diabetes.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

18

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Munich, Germany
        • Munich, 81377, Germany

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Evaluate the effects of acute effects of vildagliptin on gastric emptying

Secondary Outcome Measures

Outcome Measure
Effect on steady state levels of active GLP-1 and GIP
Change in fasting and postprandial glucose levels.
Change in glucagon secretion
Change in postprandial glucose kinetics
Effect on gastric peristalsis
Effect on satiety

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Actual)

November 1, 2006

Study Completion (Actual)

November 1, 2006

Study Registration Dates

First Submitted

September 22, 2006

First Submitted That Met QC Criteria

September 22, 2006

First Posted (Estimate)

September 26, 2006

Study Record Updates

Last Update Posted (Actual)

February 23, 2017

Last Update Submitted That Met QC Criteria

February 20, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLAF237A2378

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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