Back to resultsA Study to Assess the Acute Effects of Vildagliptin on Gastric Emptying in Patients With Type 2 Diabetes.
Primary Purpose
Diabetes Mellitus, Type 2
Status
Completed
Phase
Phase 3
Locations
Germany
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, gastric emptying
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
Sites / Locations
- Munich, 81377, Germany
Outcomes
Primary Outcome Measures
Evaluate the effects of acute effects of vildagliptin on gastric emptying
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00380380
Brief Title
A Study to Assess the Acute Effects of Vildagliptin on Gastric Emptying in Patients With Type 2 Diabetes.
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
November 2006 (Actual)
Study Completion Date
November 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis
4. Oversight
5. Study Description
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.
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, gastric emptying
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
Single
Allocation
Randomized
Enrollment
18 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Vildagliptin
Primary Outcome Measure Information:
Title
Evaluate the effects of acute effects of vildagliptin on gastric emptying
Secondary Outcome Measure Information:
Title
Effect on steady state levels of active GLP-1 and GIP
Title
Change in fasting and postprandial glucose levels.
Title
Change in glucagon secretion
Title
Change in postprandial glucose kinetics
Title
Effect on gastric peristalsis
Title
Effect on satiety
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Munich, 81377, Germany
City
Munich
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
17303799
Citation
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.
Results Reference
result
Learn more about this trial
A Study to Assess the Acute Effects of Vildagliptin on Gastric Emptying in Patients With Type 2 Diabetes.
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