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

Phase 3

Completed

• Conditions: Diabetes Mellitus, Type 2

• Registration Number: NCT00351546
• Lead Sponsor: Novartis

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-02
• Primary Completion: 2005-11
• Study Completion: 2005-12
• 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: 12

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

Other protocol-defined inclusion/exclusion criteria may apply

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Effect on insulin sensitivity at 6 weeks

Secondary Outcome Measures

Name	Time	Method
Lipolysis rate after 6 weeks of treatment
Glucose disposal after 6 weeks of treatment
Gluconeogenesis rate after 6 weeks of treatment
Plasma free fatty acid concentration after 6 weeks of treatment
Hepatic glucose production after 6 weeks of treatment