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
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
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
Observational study model:
Other
Primary completion date:
Not applicable
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

Trial location(s)

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

Study documents

Scientific result summary
Available language(s): English

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

Results overview

Refer to study documents

Recruitment status
Finalized
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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