Insulin Resistance as Primary Pathogenesis in Newly Diagnosed, Drug naïve Type 2 Diabetes Patients in Korea

GlaxoSmithKline1,439 enrolled

Overview

The purpose of this study is investigating the clinical characteristics of newly diagnosed, drug naïve type 2 diabetic patients according to insulin secretion and insulin resistance.

Primary Objective:To investigate whether insulin resistance or insulin deficiency is primary in the pathogenesis of type 2 diabetes mellitus in Korea Secondary Objectives:To investigate proportion of patients with severe insulin deficiency at diagnosis,To investigate proportion of metabolic syndrome in patients with newly diagnosed, drug-naïve type 2 diabetes mellitus,To investigate proportion of obesity in patients with newly diagnosed, drug-naïve type 2 diabetes mellitus

Study Type

OBSERVATIONAL

Enrollment

1,439

Conditions

Diabetes Mellitus, Type 2

Interventions

HOMA-IROTHER

Blood sampling for HOMA-IR and HbA1C, fasting glucose, C-peptide, Lipid profile

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria:Newly diagnosed, drug naïve type 2 DM patients who gave informed consent, Diagnosis of type 2 DM will be made according to ADA guideline 2009 Exclusion Criteria:Patients age under 18 years

Locations (2)

GSK Investigational Site

Bucheon-si, South Korea

GSK Investigational Site

Seoul, South Korea

Outcomes

Primary Outcomes

insulin resistance assessed using HOMA-IR

Time frame: within 3months after DM diagnosis

Secondary Outcomes

proportion of patients with severe insulin deficiency assessed using C-peptide

Time frame: within 3months after DM diagnosis

proportion of metabolic syndrome in patients

Time frame: within 3months after DM diagnosis

proportion of obesity in patients

Time frame: within 3months after DM diagnosis

Data from ClinicalTrials.gov

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