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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00351546
• Other study ID #: CLAF237A2352
• Status: Completed
• Phase: Phase 3
• First received: July 11, 2006
• Last updated: May 4, 2012
• Start date: February 2005
• Est. completion date: December 2005

Study information

• Verified date: May 2012
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 2005
• Est. primary completion date: November 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Insulin Resistance

Intervention

Drug:
• Vildagliptin

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect on insulin sensitivity at 6 weeks
Secondary	Lipolysis rate after 6 weeks of treatment
Secondary	Plasma free fatty acid concentration after 6 weeks of treatment
Secondary	Hepatic glucose production after 6 weeks of treatment
Secondary	Glucose disposal after 6 weeks of treatment
Secondary	Gluconeogenesis rate after 6 weeks of treatment