Last updated: 11/03/2018 15:00:26

Insulin resistance as primary pathogenesis in newly diagnosed, drug naïve type 2 diabetes patients in KoreaSURPRISE

GSK study ID
113417
See study documents
Clinicaltrials.gov ID
NCT01154244
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Insulin resistance as primary pathogenesis in newly diagnosed, drug naïve type 2 diabetes patients in Korea
Trial description: 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 purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

insulin resistance assessed using HOMA-IR

Timeframe: within 3months after DM diagnosis

Secondary outcomes:

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

Timeframe: within 3months after DM diagnosis

proportion of metabolic syndrome in patients

Timeframe: within 3months after DM diagnosis

proportion of obesity in patients

Timeframe: within 3months after DM diagnosis

Interventions:
  • Other: HOMA-IR
    • Enrollment:
    1439
    Primary completion date:
    Not applicable
    Observational study model:
    Other
    Time perspective:
    Prospective
    Clinical publications:
    Not applicable
    Medical condition
    Diabetes Mellitus, Type 2
    Product
    Not applicable
    Collaborators
    Not applicable
    Study date(s)
    September 2009 to May 2010
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    No
    • 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
    • Patients age under 18 years
    Inclusion and exclusion 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

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Seoul, South Korea, 110-749
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Bucheon, South Korea, 150-713
    Status
    Study Complete
    Contact us

    Study documents

    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2010-27-05

    Plain language summaries

    Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

    Not applicable
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    Access to clinical trial data by researchers
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