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

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ClinicalTrials.gov Identifier: NCT01154244
Recruitment Status : Completed
First Posted : June 30, 2010
Last Update Posted : January 25, 2011
Sponsor:
Information provided by:
GlaxoSmithKline

Brief Summary:
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.

Condition or disease Intervention/treatment
Diabetes Mellitus, Type 2 Other: HOMA-IR

Detailed Description:
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
Actual Enrollment : 1439 participants
Time Perspective: Prospective
Official Title: Insulin Resistance as Primary Pathogenesis in Newly Diagnosed, Drug naïve Type 2 Diabetes Patients in Korea
Study Start Date : September 2009
Actual Primary Completion Date : July 2010
Actual Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Insulin

Group/Cohort Intervention/treatment
Drug naive type II DM
Newly diagnosed type II Diabetes Mellitus
Other: HOMA-IR
Blood sampling for HOMA-IR and HbA1C, fasting glucose, C-peptide, Lipid profile




Primary Outcome Measures :
  1. insulin resistance assessed using HOMA-IR [ Time Frame: within 3months after DM diagnosis ]

Secondary Outcome Measures :
  1. proportion of patients with severe insulin deficiency assessed using C-peptide [ Time Frame: within 3months after DM diagnosis ]
  2. proportion of metabolic syndrome in patients [ Time Frame: within 3months after DM diagnosis ]
  3. proportion of obesity in patients [ Time Frame: within 3months after DM diagnosis ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Newly diagnosed Type II DM, Drug naive
Criteria
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01154244


Locations
Korea, Republic of
GSK Investigational Site
Bucheon, Korea, Republic of, 150-713
GSK Investigational Site
Seoul, Korea, Republic of, 110-749
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline

Responsible Party: E.D. Derilus; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT01154244     History of Changes
Other Study ID Numbers: 113417
First Posted: June 30, 2010    Key Record Dates
Last Update Posted: January 25, 2011
Last Verified: January 2011

Keywords provided by GlaxoSmithKline:
Insulin resistance
Insulin deficiency
HOMA-IR
Drug naive
Diabetes mellitus, type II

Additional relevant MeSH terms:
Diabetes Mellitus
Insulin Resistance
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperinsulinism
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs