Diabetes Mellitus, Type 2SURPRISENCT01154244
Insulin Resistance as Primary Pathogenesis in Newly Diagnosed, Drug naïve Type 2 Diabetes Patients in Korea
An observational study of Diabetes Mellitus, Type 2, run by GlaxoSmithKline at 2 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- HOMA-IR
- How many people
- 1,439 participants
- Where
- 2 sitesSouth Korea
- Study dates
- Sep 2009to Jul 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Newly diagnosed Type II DM, Drug naive
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 locations and contacts
2 sites in 1 country.
South Korea2 sites
GSK Investigational Site
Bucheon-si, 150-713
GSK Investigational Site
Seoul, 110-749
About this study
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.
Read the 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
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- HOMA-IR
- Keywords
- Insulin resistance, Insulin deficiency, HOMA-IR, Drug naive, Diabetes mellitus, type II
- Medical subject headings
- Diabetes Mellitus, Type 2, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HOMA-IROther
Blood sampling for HOMA-IR and HbA1C, fasting glucose, C-peptide, Lipid profile
| Study group | Role | What they receive |
|---|---|---|
| Drug naive type II DM | Newly diagnosed type II Diabetes Mellitus Receives: Other: HOMA-IR |
What is being measured
The primary outcome is the main question the study is designed to answer.
insulin resistance assessed using HOMA-IR
Measured: within 3months after DM diagnosis
Secondary outcomes (3)
proportion of patients with severe insulin deficiency assessed using C-peptide
Measured: within 3months after DM diagnosis
proportion of metabolic syndrome in patients
Measured: within 3months after DM diagnosis
proportion of obesity in patients
Measured: within 3months after DM diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2010 (estimated)
- Study startSep 2009
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 1,439 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01154244
- Sponsor's protocol ID
- 113417
- Acronym
- SURPRISE
- Status last verified
- Jan 2011
- First submitted
- 29 Jun 2010
- Last updated
- 25 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Insulin Resistance as Primary Pathogenesis in Newly Diagnosed, Drug naïve Type 2 Diabetes Patients in Korea
- ClinicalTrials.gov ID
- NCT01154244
- Acronym / sponsor ID
- SURPRISE / 113417
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Insulin resistance, Insulin deficiency, HOMA-IR, Drug naive, Diabetes mellitus, type II
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,439 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 30 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Drug naive type II DM | – | Other: HOMA-IRNewly diagnosed type II Diabetes Mellitus |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Newly diagnosed Type II DM, Drug naive
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HOMA-IRBlood sampling for HOMA-IR and HbA1C, fasting glucose, C-peptide, Lipid profile | Other | Drug naive type II DM |
Primary outcome
insulin resistance assessed using HOMA-IR
Time frame: within 3months after DM diagnosis
3 secondary outcomes
proportion of patients with severe insulin deficiency assessed using C-peptide
Time frame: within 3months after DM diagnosis
proportion of metabolic syndrome in patients
Time frame: within 3months after DM diagnosis
proportion of obesity in patients
Time frame: within 3months after DM diagnosis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 2, run by GlaxoSmithKline at 2 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
insulin resistance assessed using HOMA-IR (time frame: within 3months after DM diagnosis). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2011; AzTrials last refreshed its copy on 7 Nov 2026.