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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 19, 2014