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

Novartis

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Vildagliptin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00351507

CLAF237A2343

Details and patient eligibility

About

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

Enrollment: 10 patients

Sex: All

Ages: 35 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind