A Study to Assess the Acute Effects of Vildagliptin on Gastric Emptying in Patients With Type 2 Diabetes.
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.
1 other identifier
interventional
18
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 diabetes-mellitus-type-2
Started Jan 2006
Shorter than P25 for phase_3 diabetes-mellitus-type-2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2006
CompletedFirst Submitted
Initial submission to the registry
September 22, 2006
CompletedFirst Posted
Study publicly available on registry
September 26, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2006
CompletedFebruary 23, 2017
February 1, 2017
10 months
September 22, 2006
February 20, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Evaluate the effects of acute effects of vildagliptin on gastric emptying
Secondary Outcomes (6)
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
- +1 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novartislead
Study Sites (1)
Munich, 81377, Germany
Munich, Germany
Related Publications (1)
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.
PMID: 17303799RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 22, 2006
First Posted
September 26, 2006
Study Start
January 1, 2006
Primary Completion
November 1, 2006
Study Completion
November 1, 2006
Last Updated
February 23, 2017
Record last verified: 2017-02