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

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Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Diabetes Mellitus, Type 2

Interventions

VildagliptinDRUG

Eligibility

Sex: ALLMin age: 21 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Effect on insulin sensitivity at 6 weeks

Secondary Outcomes

Lipolysis rate after 6 weeks of treatment

Plasma free fatty acid concentration after 6 weeks of treatment

Hepatic glucose production after 6 weeks of treatment

Glucose disposal after 6 weeks of treatment

Gluconeogenesis rate after 6 weeks of treatment

Data from ClinicalTrials.gov

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