A Study to Assess the Effects of DPP-4 Inhibition on Insulin Sensitivity in Type 2 Diabetes

NCT ID: NCT00351546

Last Updated: 2012-05-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-02-28
• Study Completion Date: 2005-12-31

Brief Summary

Type 2 diabetes results when the body does not produce enough insulin and/or is unable to properly use the insulin it makes (insulin resistance). This study was undertaken to assess the effects of vildagliptin on insulin sensitivity in people with type 2 diabetes.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Vildagliptin

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Diagnosed with type 2 diabetes at least 3 months prior to screening
• Blood glucose criteria must be met
• On stable dose of metformin therapy
• BMI less than or equal to 39

Exclusion Criteria

• Type 1 diabetes, diabetes resulting from pancreatic injury or secondary forms of diabetes
• Treatment with thiazolidinediones or use of insulin within the previous 3 months
• Significant illness within 2 weeks prior to dosing
• High fasting triglycerides as defined by the protocol

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis

INDUSTRY

Sponsor Role: lead

Principal Investigators

David Kelley, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Other Identifiers

CLAF237A2352

Identifier Type: -

Identifier Source: org_study_id