Type 2 Diabetes MellitusPhase 4KIITNCT00474838
Study To Evaluate Beta Cell Function and Glycemic Outcome by Intensive Insulin Therapy
A Phase 4 study testing intensive insulin group and Oral AntiDiabetic Drug (glimepiride and metformin) in people with Type 2 Diabetes Mellitus and Pancreatic Beta Cell Function, run by Kyunghee University Medical Center at 8 sites in South Korea.
Trial summary
This randomized controlled prospective study aims to evaluate the efficacy of intensive insulin therapy for long term glycemic control and improvement or preservation of beta cell function in newly diagnosed type 2 diabetes patients. Read more about this study
- Who is it for?
- Ages 25 to 70 years
- Conditions the study is for
- Type 2 Diabetes Mellitus, Pancreatic Beta Cell Function, Glucotoxicity
- What is being tested?
- intensive insulin group and Oral AntiDiabetic Drug (glimepiride and metformin)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 8 sitesSouth Korea
- Study dates
- Apr 2007to Dec 2012
- Phase
- Phase 4
- 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 25 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Newly diagnosed drug naïve type 2 diabetic patient with typical diabetic symptom (polydipsia, polyuria, unexplained weight loss) within recent 1 year
- Initial HbA1c : 8.0 % ≤ HbA1c < 12.0%
Who cannot join
- Known contraindication to insulin glargine, insulin glulisine, metformin, glimepiride
- Patients with proliferative diabetic retinopathy
- Severe liver disease or AST, ALT ≥ 2.5 x ULN
- History of lactic acidosis
- Unstable or severe angina
- Congestive heart failure
Show all 9Show fewer
- Chronic disease treated with continuous corticosteroid therapy
- Diagnosis of cancer
- Positive urine pregnancy test or plan to become pregnant during the clinical trial
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
South Korea8 sites
The Catholic University of Korea Bucheon St.Mary's Hospital
Bucheon-si
Hanyang University Medical Center
Guri-si, Gyeonggi-do, 471-020
Inha University Hospital
Incheon, 400-711
Jeju National University Hospital
Jeju-do
Kyunghee University Medical Center
Seoul, 130-702
Korea University Guro Hospital
Seoul, 152-730
Kyung Hee University East Weast Neo Medicalcenter
Seoul
Ajou University Medical Center
Suwon, 443-721
About this study
Official title: The Effect of Intensive and Short-term Insulin Treatment on Long-term Pancreatic β-cell Function in Newly Diagnosed People With Type 2 Diabetes in Korea
This randomized controlled prospective study aims to evaluate the efficacy of intensive insulin therapy for long term glycemic control and improvement or preservation of beta cell function in newly diagnosed type 2 diabetes patients.
Read the detailed description
Type 2 diabetes is associated with beta cell dysfunction and insulin action at diagnosis of diabetes. Although the relative importance of these two alterations is controversial, growing evidence is swinging to the concept that there is no hyperglycemia without β-cell dysfunction. Also there is agreement that deterioration of glucose tolerance over time is associated with a progressive decrease of beta cell function.
Beside the role of genetic factor, the continuous decline in β-cell function is affected by glucotoxicity generated by hyperglycemia and lipotoxicity due to high fatty acid. A vicious cycle of hyperglycemia per se further impairs and may destroy β-cell. Recently, many reports have shown that early intensive glycemic control plays a role in the prevention of progressive ß-cell function and worsening of diabetes.
Some studies have shown that early intensive insulin therapy(IIT) to achieve near normoglycemia in new onset type 2 diabetes gives short term and long term improvement in glycemic control after discontinuation of insulin. It is suggested that long term glycemic control is associated with improvement of β-cell function.
In the unpublished previous pilot study, the investigators found that early intensive insulin therapy using multiple daily injection (MDI) or daily twice injection in newly diagnosed type 2 diabetes can significantly improve the beta cell function and facilitate further long term glycemic control. To establish the effectiveness of intensive insulin therapy for long term glycemic control and improvement of β-cell function, the investigators will perform a randomized controlled prospective study in newly diagnosed type 2 diabetes in Korea.
- Being tested
- intensive insulin group, Oral AntiDiabetic Drug (glimepiride and metformin)
- Keywords
- type 2 diabetes mellitus, intensive insulin therapy
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intensive insulin groupDrug
Once daily long acting insulin and preprandial rapid acting insulin injection
Oral AntiDiabetic Drug (glimepiride and metformin)Drug
Also called glimepiride(amaryl), metformin(diabex)
glimepiride and metformin combined therapy
| Study group | Role | What they receive |
|---|---|---|
| Oral AntiDiabetic Drug | Active comparator | glimepiride and metformin and/or once daily glargine Receives: Drug: Oral AntiDiabetic Drug (glimepiride and metformin) |
| intensive insulin group | Experimental | insulin glargine insulin glulisine Receives: Drug: intensive insulin group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Long-term glycemic control
Measured: up to 2 years
Change of pancreatic beta cell function
Measured: up to 2 years
Secondary outcomes (2)
Inflammatory marker and insulin sensitivity
Measured: up to 2 years
Time to reach target goal of blood glucose level
Measured: up to 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2007 (estimated)
- Study startApr 2007
- Primary completionAug 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyunghee University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Korea University Guro Hospital, Hanyang University, Inha University Hospital, Ajou University, Sanofi, East West Neo Medical Center, The Catholic University of Korea, Jeju National University Hospital
- Responsible party
- Principal investigator, Jeong-taek Woo, Kyunghee University Medical Center
- Investigators
- Jeong-taek Woo, MD, PhD, Principal investigator, Kyunghee University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00474838
- Sponsor's protocol ID
- KIIT-KMC-0701
- Acronym
- KIIT
- Status last verified
- Sep 2013
- First submitted
- 16 May 2007
- Last updated
- 26 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Intensive and Short-term Insulin Treatment on Long-term Pancreatic β-cell Function in Newly Diagnosed People With Type 2 Diabetes in Korea
- ClinicalTrials.gov ID
- NCT00474838
- Acronym / sponsor ID
- KIIT / KIIT-KMC-0701
- Keywords
- type 2 diabetes mellitus, intensive insulin therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Kyunghee University Medical CenterUniversity, hospital or other
- Collaborators
- Korea University Guro Hospital, Hanyang University, Inha University Hospital, Ajou University, Sanofi, East West Neo Medical Center, The Catholic University of Korea, Jeju National University Hospital
- Study start
- Apr 2007
- Primary completion
- Aug 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 17 May 2007 (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.
This randomized controlled prospective study aims to evaluate the efficacy of intensive insulin therapy for long term glycemic control and improvement or preservation of beta cell function in newly diagnosed type 2 diabetes patients.
Detailed description
Type 2 diabetes is associated with beta cell dysfunction and insulin action at diagnosis of diabetes. Although the relative importance of these two alterations is controversial, growing evidence is swinging to the concept that there is no hyperglycemia without β-cell dysfunction. Also there is agreement that deterioration of glucose tolerance over time is associated with a progressive decrease of beta cell function.
Beside the role of genetic factor, the continuous decline in β-cell function is affected by glucotoxicity generated by hyperglycemia and lipotoxicity due to high fatty acid. A vicious cycle of hyperglycemia per se further impairs and may destroy β-cell. Recently, many reports have shown that early intensive glycemic control plays a role in the prevention of progressive ß-cell function and worsening of diabetes.
Some studies have shown that early intensive insulin therapy(IIT) to achieve near normoglycemia in new onset type 2 diabetes gives short term and long term improvement in glycemic control after discontinuation of insulin. It is suggested that long term glycemic control is associated with improvement of β-cell function.
In the unpublished previous pilot study, the investigators found that early intensive insulin therapy using multiple daily injection (MDI) or daily twice injection in newly diagnosed type 2 diabetes can significantly improve the beta cell function and facilitate further long term glycemic control. To establish the effectiveness of intensive insulin therapy for long term glycemic control and improvement of β-cell function, the investigators will perform a randomized controlled prospective study in newly diagnosed type 2 diabetes in Korea.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral AntiDiabetic Drug | Active comparator | Drug: Oral AntiDiabetic Drug (glimepiride and metformin)glimepiride and metformin and/or once daily glargine |
| intensive insulin group | Experimental | Drug: intensive insulin groupinsulin glargine insulin glulisine |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Newly diagnosed drug naïve type 2 diabetic patient with typical diabetic symptom (polydipsia, polyuria, unexplained weight loss) within recent 1 year
- Initial HbA1c : 8.0 % ≤ HbA1c < 12.0%
Key exclusion criteria (9 listed)
- Known contraindication to insulin glargine, insulin glulisine, metformin, glimepiride
- Patients with proliferative diabetic retinopathy
- Severe liver disease or AST, ALT ≥ 2.5 x ULN
- History of lactic acidosis
- Unstable or severe angina
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 |
|---|---|---|
| intensive insulin groupOnce daily long acting insulin and preprandial rapid acting insulin injection | Drug | intensive insulin group |
| Oral AntiDiabetic Drug (glimepiride and metformin)Also: glimepiride(amaryl), metformin(diabex)glimepiride and metformin combined therapy | Drug | Oral AntiDiabetic Drug |
Primary outcome
Long-term glycemic control
Time frame: up to 2 years
Change of pancreatic beta cell function
Time frame: up to 2 years
2 secondary outcomes
Inflammatory marker and insulin sensitivity
Time frame: up to 2 years
Time to reach target goal of blood glucose level
Time frame: up to 2 year
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 26 Sep 2013.
Related trials for Type 2 Diabetes Mellitus
Not yet recruiting
Efficacy, Safety, and Treatment Satisfaction of Once-Weekly Tirzepatide in Obese Type 2 Diabetic Patients
Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
Active, not recruiting
Helping Adults With Type 2 Diabetes Use Their Health Data for Healthy Diabetes Self-Management
Type 2 Diabetes Mellitus (T2DM)
Not yet recruiting
Care COMPASS Study
Diabetes Mellitus ( Type 1 and Type 2), Hypertension
Enrolling by invitationObservational study
Personalizing A1c Using Hematologic Indices and CGM for Accurate Diabetes Diagnosis
Type 2 Diabetes
RecruitingObservational study
Investigating the Link Between Advanced Glycation End Products (AGEs) and Muscle Wasting in Sarcobesity
Sarcopenia, Obesity
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.
Jeong-taek Woo, MD, PhD principal investigator
Kyunghee University Medical Center
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing intensive insulin group and Oral AntiDiabetic Drug (glimepiride and metformin) in people with Type 2 Diabetes Mellitus and Pancreatic Beta Cell Function, run by Kyunghee University Medical Center at 8 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?
The sponsor lists 2 inclusion and 9 exclusion criteria. 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 26 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Long-term glycemic control (time frame: up to 2 years). The study lists 2 primary outcomes in all. 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 26 Sep 2013.