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

Phase 3

Completed

• Conditions: Diabetes Mellitus, Type 2

• Registration Number: NCT00351507
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

This study was designed to directly assess the effects of vildagliptin on gastric emptying in people with type 2 diabetes.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-05
• Primary Completion: 2006-02
• Study Completion: 2006-02
• Study First Submitted: 2006-07-11
• Study First Submitted QC: 2006-07-11
• Study First Posted: 2006-07-13
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-04
• Last Update Posted: 2012-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Effect on gastric emptying

Secondary Outcome Measures

Name	Time	Method
Effect on gastric volume
Effect on satiety
Effect on endogenous glucose appearance, glucose appearance and glucose disposal

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States