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

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01154244
First received: June 29, 2010
Last updated: January 22, 2011
Last verified: January 2011
History of Changes
  Purpose

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 Intervention
Diabetes Mellitus, Type 2
 Other: HOMA-IR

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Insulin Resistance as Primary Pathogenesis in Newly Diagnosed, Drug naïve Type 2 Diabetes Patients in Korea

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • insulin resistance assessed using HOMA-IR [ Time Frame: within 3months after DM diagnosis ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • proportion of patients with severe insulin deficiency assessed using C-peptide [ Time Frame: within 3months after DM diagnosis ] [ Designated as safety issue: No ]
  • proportion of metabolic syndrome in patients [ Time Frame: within 3months after DM diagnosis ] [ Designated as safety issue: No ]
  • proportion of obesity in patients [ Time Frame: within 3months after DM diagnosis ] [ Designated as safety issue: No ]

Enrollment: 1439
Study Start Date: September 2009
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: E.D. Derilus; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT01154244     History of Changes
Other Study ID Numbers: 113417
Study First Received: June 29, 2010
Last Updated: January 22, 2011
Health Authority: Korea: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on May 23, 2013