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

• Status: Completed
• Trial end date: 2005-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis
• Treatments: Insulin; Insulin, Globin Zinc; Vildagliptin

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

Other protocol-defined inclusion/exclusion criteria may apply