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

• Sponsor: Novartis (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00380380
• Collaborator: (none)
• Enrollment: 18
• Location: 1
• Duration (Months): 10
• Patients Per Site Per Month: 1.8

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 2	Drug: Vildagliptin	Phase 3

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single
• Primary Purpose: Treatment
• 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 Start Date: Jan 1, 2006
• Actual Primary Completion Date: Nov 1, 2006
• Actual Study Completion Date: Nov 1, 2006

Outcome Measures

Primary Outcome Measures

1. Evaluate the effects of acute effects of vildagliptin on gastric emptying []

Secondary Outcome Measures

1. Effect on steady state levels of active GLP-1 and GIP []

2. Change in fasting and postprandial glucose levels. []

3. Change in glucagon secretion []

4. Change in postprandial glucose kinetics []

5. Effect on gastric peristalsis []

6. Effect on satiety []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 65 Years
• Sexes Eligible for Study: All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Munich, 81377, Germany	Munich		Germany

Sponsors and Collaborators

• Novartis

Investigators

• Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Novartis
• ClinicalTrials.gov Identifier: NCT00380380
• Other Study ID Numbers: CLAF237A2378
• First Posted: Sep 26, 2006
• Last Update Posted: Feb 23, 2017
• Last Verified: Feb 1, 2017

• Keywords provided by Novartis: Vildagliptin, type 2 diabetes, gastric emptying
• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Vildagliptin

Study Results

No Results Posted as of Feb 23, 2017