Insulin Resistance as Primary Pathogenesis in Newly Diagn... | NCT01154244

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

NCT01154244

Sponsor

GlaxoSmithKline

Status

Completed

Last Update Posted

Jan 25, 2011Estimated

Enrollment

1,439Actual

Phase

Not provided

Conditions

Diabetes Mellitus, Type 2

Interventions

HOMA-IR

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2009

Primary Completion Date

Jul 2010Actual

Completion Date

Jul 2010Actual

First Submitted Date

Jun 29, 2010

First Submission Date that Met QC Criteria

Jun 29, 2010

First Posted Date

Jun 30, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 22, 2011

Last Update Posted Date

Jan 25, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,439Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Drug naive type II DM		Newly diagnosed type II Diabetes Mellitus	Other: HOMA-IR

Interventions

Name	Type	Description	Arm Group Labels	Other Names
HOMA-IR	Other	Blood sampling for HOMA-IR and HbA1C, fasting glucose, C-peptide, Lipid profile	Drug naive type II DM

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
insulin resistance assessed using HOMA-IR		within 3months after DM diagnosis

Secondary Outcomes

Measure	Description	Time Frame
proportion of patients with severe insulin deficiency assessed using C-peptide		within 3months after DM diagnosis
proportion of metabolic syndrome in patients		within 3months after DM diagnosis

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Newly diagnosed Type II DM, Drug naive

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Bucheon-si		150-713	South Korea
GSK Investigational Site

Condition Browse Module

MeSH Terms

ID	Term
D003924	Diabetes Mellitus, Type 2
D007333	Insulin Resistance

Ancestor Terms

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided