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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00380380
First received: September 22, 2006
Last updated: February 20, 2017
Last verified: February 2017

September 22, 2006
February 20, 2017
January 2006
November 2006   (Final data collection date for primary outcome measure)
Evaluate the effects of acute effects of vildagliptin on gastric emptying
Same as current
Complete list of historical versions of study NCT00380380 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
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.
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (masked role unspecified)
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
Drug: Vildagliptin
Not Provided
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. Epub 2007 Feb 15.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
November 2006
November 2006   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
30 Years to 65 Years   (Adult)
Not Provided
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT00380380
CLAF237A2378
Not Provided
Not Provided
Not Provided
Not Provided
Novartis
Novartis
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP