Back to resultsA Study to Assess the Effects of Vildagliptin on Gastric Emptying in Patients With Type 2 Diabetes
Primary Purpose
Diabetes Mellitus, Type 2
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Vildagliptin
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring Vildagliptin, Type 2 diabetes
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
Sites / Locations
- Mayo Clinic
Outcomes
Primary Outcome Measures
Effect on gastric emptying
Secondary Outcome Measures
Effect on gastric volume
Effect on satiety
Effect on endogenous glucose appearance, glucose appearance and glucose disposal
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00351507
Brief Title
A Study to Assess the Effects of Vildagliptin on Gastric Emptying in Patients With Type 2 Diabetes
Official Title
A Double-blind, Crossover, Placebo-Controlled, Multiple-dose Study to Evaluate the Effects of Vildagliptin on Gastric Emptying, Gastric Volume and Satiety in Patients With Type 2 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
May 2005 (undefined)
Primary Completion Date
February 2006 (Actual)
Study Completion Date
February 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals
4. Oversight
5. Study Description
Brief Summary
This study was designed to directly assess the effects of vildagliptin on gastric emptying in people with type 2 diabetes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
Vildagliptin, Type 2 diabetes
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Vildagliptin
Primary Outcome Measure Information:
Title
Effect on gastric emptying
Secondary Outcome Measure Information:
Title
Effect on gastric volume
Title
Effect on satiety
Title
Effect on endogenous glucose appearance, glucose appearance and glucose disposal
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adrian Vella, MD
Organizational Affiliation
Mayo Clinic & Foundation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
18931099
Citation
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.
Results Reference
derived
Learn more about this trial
A Study to Assess the Effects of Vildagliptin on Gastric Emptying in Patients With Type 2 Diabetes
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