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

June 29, 2010
January 22, 2011
September 2009
July 2010   (final data collection date for primary outcome measure)
insulin resistance assessed using HOMA-IR [ Time Frame: within 3months after DM diagnosis ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01154244 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Insulin Resistance as Primary Pathogenesis in Newly Diagnosed, Drug naïve Type 2 Diabetes Patients in Korea
Insulin Resistance as Primary Pathogenesis in Newly Diagnosed, Drug naïve Type 2 Diabetes Patients in Korea

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

Observational
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Newly diagnosed Type II DM, Drug naive

Diabetes Mellitus, Type 2
Other: HOMA-IR
Blood sampling for HOMA-IR and HbA1C, fasting glucose, C-peptide, Lipid profile
Drug naive type II DM
Newly diagnosed type II Diabetes Mellitus
Intervention: Other: HOMA-IR
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1439
July 2010
July 2010   (final data collection date for primary outcome measure)

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

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01154244
113417
No
E.D. Derilus; Clinical Disclosure Advisor, GSK Clinical Disclosure
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP