Cardiovascular DiseasesJ-DOIT3NCT00300976
The Japan Diabetes Optimal Integrated Treatment Study for 3 Major Risk Factors of Cardiovascular Diseases
A study of Cardiovascular Diseases and Diabetes Mellitus, Type 2, run by Japan Foundation for the Promotion of International Medical Research Cooperation at 1 site in Japan.
Trial summary
(Intervention study) The objective of the study is to confirm the superiority of the intensive therapy to the conventional therapy concerning the prevention of the incidence or exacerbation of vascular complications caused by diabetes mellitus (DM) by a randomized controlled study in patients with type 2 DM. Read more about this study
- Who is it for?
- Ages 45 to 69 years
- Conditions the study is for
- Cardiovascular Diseases, Diabetes Mellitus, Type 2
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,542 participants
- Where
- 1 siteJapan
- Study dates
- May 2006to Jun 2021
- Phase
- Interventional
- 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 45 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects were considered eligible if they were 45 years old or older but younger than 70 years old at study entry, had type 2 diabetes and met both "(1) and (2)" or both "(1) and (3)" described below. [Note: Those who met all three "(1), (2) and (3)" were also considered eligible for inclusion.](1) Glycemic control Those with HbA1c 6.9% or greater despite treatment with any of the three regimens given below. Diet and exercise therapy alone, Diet and exercise therapy plus 1 oral anti-diabetic drug, Diet and exercise therapy plus, GI and 1 other oral anti-anti-diabetic drug (2) Blood pressure control Those with the following casual blood pressure (BP) level as measured on an outpatient basis, Systolic BP 140 mmHg or diastolic BP 90 mmHg while not on an antihypertensive agent, Systolic BP 130 mmHg or diastolic BP 80 mmHg while on 1 or 2 ARB, ACEI or long-acting CCB Those receiving antihypertensive agents other than ARB, ACEI or long-acting CCB were not eligible for study entry, with the exception of those who were receiving these agents for other purposes than blood pressure lowering. (3) Lipid metabolism Those with the following fasting lipid levels while not on a lipid-lowering agent LDL-cholesterol, 120 mg/dL (as calculated by using the Friedewald formula) Triglycerides, 150 mg/dL HDL-cholesterol, < 40 mg/dL Subjects receiving 1 lipid-lowering agent were judged eligible for study entry if they met any of the above criteria. However, care needs to be taken to ensure that those on fibrates discontinue the fibrate treatment at the start of the study when they are assigned to the intensive therapy arm.
- Of the subjects in the randomized controlled study comparing intensive therapy and conventional therapy in type 2 diabetic patients (J-DOIT3), those who provide written informed consent to participate in the follow-up study will be enrolled regardless of completion or discontinuation from the randomized controlled study (If the subject is unable to provide informed consent for any reason, consent from his/her legal representative is allowed).
Who cannot join
- 1. Those with poorly controlled hypertension despite pharmacological therapy (systolic BP 200 mmHg or diastolic BP 120 mmHg) 2. Those on insulin therapy 3. Those with non-diabetic renal disease 4. Those in whom type 1 and other diabetes due to pathogenic mechanisms other than those associated with type 2 diabetes is strongly suspected 5. Those who tested anti-GAD antibody-positive 6. Those with LDL-cholesterol 200 mg/dL 7. Those suspected of having secondary hypertension other than renal parenchymal hypertension 8. Those suspected of having hereditary lipid disorder with a strong family history of lipid metabolic disorder 9. Those who were receiving antihypertensive agents other than ARB, ACEI, long-acting CCB, except where they were receiving these agents for other purposes than blood pressure lowering 10. Those who were receiving 3 or more antihypertensive agents (i.e., ARB, ACEI, and long-acting CCB), except where they were receiving these agents for other purposes than blood pressure lowering 11. Those with more serious retinopathy than proliferative retinopathy 12. Renal failure (serum Cr: 2.0 mg/dL in men; 1.5 mg/dL in women) 13. Those with a history of cardiac failure or those with cardiac failure 14. Those who were pregnant or potentially pregnant 15. Those who met any of the following criteria and who had BNP 100 pg/mL, Myocardial infarction, Angina pectoris (or a history of disease), History of coronary artery bypass graft (CABG), History of percutaneous coronary angioplasty (PTCA), Other cardiac disease, ECG findings of left ventricular hyperplasia, Abnormal ECG findings (excluding isolated extrasystole or right bundle branch block [RBBB]) 16. Those judged by the physician in charge to be ineligible for study entry
- (Follow-up study)
- A subject who is assessed as ineligible by the investigator will be excluded from the follow-up study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: (Intervention Study) A Randomized Controlled Study of the Intensive Therapy and the Conventional Therapy for the Suppression of the Vascular Complications in the Type 2 Diabetic Patients (Follow-up Study) A Randomized Controlled Study Comparing Intensive Therapy and Conventional Therapy in the Reduction of Vascular Complications in Type 2 Diabetic Patients: A Follow-up Study After Intervention
(Intervention study) The objective of the study is to confirm the superiority of the intensive therapy to the conventional therapy concerning the prevention of the incidence or exacerbation of vascular complications caused by diabetes mellitus (DM) by a randomized controlled study in patients with type 2 DM.
(Follow-up study) The objective of the follow-up study is to evaluate the long-term efficacy of intensive versus conventional therapy in the effect on mortality and the prevention of the incidence or exacerbation of vascular complications caused by diabetes mellitus through a post-intervention follow-up research conducted after the multi-center, open-label, randomized parallel-group study comparing the efficacy of intensive versus conventional therapy in type 2 diabetic patients.
Read the detailed description
(Intervention study) The objective of the study is to confirm the superiority of the intensive therapy to the conventional therapy concerning the prevention of the incidence or exacerbation of vascular complications caused by diabetes mellitus by a randomized controlled study in patients with type 2 DM. The primary outcome measure is occurrence of myocardial infarction, coronary bypass surgery, percutaneous transluminal coronary angioplasty, stroke, carotid endarterectomy, percutaneous transluminal cerebral angioplasty, carotid artery stenting, or death.
(Follow-up study) The objective of the follow-up study is to evaluate the long-term efficacy of intensive versus conventional therapy in the effect on mortality and the prevention of the incidence or exacerbation of vascular complications caused by diabetes mellitus through a post-intervention follow-up research conducted after the multi-center, open-label, randomized parallel-group study comparing the efficacy of intensive versus conventional therapy in type 2 diabetic patients. The primary endpoint is identical to that in the intervention study. In addition, overall survivalall-cause mortality will be evaluated as a key secondary endpoint.
- Conditions
- Cardiovascular Diseases, Diabetes Mellitus, Type 2
- Being tested
- Lifestyle consultation: weight control, diet, exercise
- Keywords
- Blood glucose, Blood pressure, Lipids
- Medical subject headings
- Cardiovascular Diseases, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle consultation: weight control, diet, exerciseBehavioural
Behavioral: Lifestyle modification including weight control, with the goal of BMI 22.
Drug: Drugs are added in a stepwise manner to control blood glucose, blood pressure and lipid metabolism, using mainly hypoglycemic drugs, ACEI/ARB and statins, respectively. Management goals are: HbA1c < 6.2%, BP < 120/75 mmHg, HDL-C 40 mg/dL , LDL-C < 80 mg/dL, TG < 120 mg/dL.
Follow-up study (Not provided)
Lifestyle consultation: weight control, diet, exerciseBehavioural
Behavioral and Drug: The physician in charge is to administer appropriate therapy in accordance with the Guidelines.
Follow-up study (Not provided)
| Study group | Role | What they receive |
|---|---|---|
| Intensive therapy | Experimental | Not described Receives: Behavioral: Lifestyle consultation: weight control, diet, exercise |
| Conventional therapy | Active comparator | Not described Receives: Behavioral: Lifestyle consultation: weight control, diet, exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
The occurrence of myocardial infarction, coronary bypass surgery, percutaneous transluminal coronary angioplasty, stroke, carotid endarterectomy, percutaneous transluminal cerebral angioplasty, carotid artery stenting, or death
Measured: Every 12 months, at the end of the study.
Secondary outcomes (5)
Occurrence of myocardial infarction, stroke or death
Measured: Every 12 months, at the end of the study.
Onset or progression of nephropathy
Measured: Every 6 months, at the end of the study.
Lower limb vascular events (amputation or revascularization of lower limb)
Measured: Every 12 months, at the end of the study.
Onset or progression of retinopathy
Measured: Every 12 months, at the end of the study.
All-cause mortality (deaths due to any cause)
This measure is only evaluated with follow-up study.
Measured: Every 12 months, at the end of the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2006 (estimated)
- Study startMay 2006
- Primary completionMar 2016
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- (Intervention study) A multi-center, open-label, randomized controlled study, which compared the efficacy of intensive therapy and conventional therapy in type 2 diabetic patients (Follow-up study) A prospective cohort study with a 5-year long-term follow-up period
- Masking
- None (open label)
- Enrolment
- 2,542 participants (actual)
Sponsor and investigators
- Lead sponsor
- Japan Foundation for the Promotion of International Medical Research Cooperation
- Sponsor type
- University, hospital or other
- Collaborators
- Japan Diabetes Foundation
- Responsible party
- Sponsor
- Investigators
- Takashi Kadowaki, Principal investigator, Tokyo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00300976
- Sponsor's protocol ID
- J-DOIT3
- Acronym
- J-DOIT3
- Status last verified
- Aug 2017
- First submitted
- 8 Mar 2006
- Last updated
- 3 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Noda M, Ueki K, Sasako T, Ishizuka N, Miyake K, Miyoshi K, Aoyama T, Okazaki Y, Ohashi Y, Yamauchi T, Kadowaki T; J-DOIT3 Study Group. Search for the glycated hemoglobin target minimizing mortality among people with type 2 diabetes with rare incidence of treatment-related severe hypoglycemia - Epidemiologic analysis of J-DOIT3 randomized controlled trial. PLoS One. 2026 Oct 23;21(10):e0360295. doi: 10.1371/journal.pone.0360295. eCollection 2026.
PubMed 42912779Sasako T, Ueki K, Miyoshi K, Miyake K, Aoyama T, Okazaki Y, Ishizuka N, Yamauchi T, Noda M, Kadowaki T; J-DOIT3 Study Group. Effect of a Multifactorial Intervention on Retinopathy in People With Type 2 Diabetes: A Secondary Analysis of the J-DOIT3 Randomized Clinical Trial. JAMA Ophthalmol. 2025 Dec 1;143(12):989-997. doi: 10.1001/jamaophthalmol.2025.3819.
PubMed 41129145Sasako T, Ueki K, Miyake K, Okazaki Y, Takeuchi Y, Ohashi Y, Noda M, Kadowaki T. Effect of a Multifactorial Intervention on Fracture in Patients With Type 2 Diabetes: Subanalysis of the J-DOIT3 Study. J Clin Endocrinol Metab. 2021 Apr 23;106(5):e2116-e2128. doi: 10.1210/clinem/dgab013.
PubMed 33491087Ueki K, Sasako T, Okazaki Y, Kato M, Okahata S, Katsuyama H, Haraguchi M, Morita A, Ohashi K, Hara K, Morise A, Izumi K, Ishizuka N, Ohashi Y, Noda M, Kadowaki T; J-DOIT3 Study Group. Effect of an intensified multifactorial intervention on cardiovascular outcomes and mortality in type 2 diabetes (J-DOIT3): an open-label, randomised controlled trial. Lancet Diabetes Endocrinol. 2017 Dec;5(12):951-964. doi: 10.1016/S2213-8587(17)30327-3. Epub 2017 Oct 24.
PubMed 29079252Ueki K, Sasako T, Kato M, Okazaki Y, Okahata S, Katsuyama H, Haraguchi M, Morita A, Ohashi K, Hara K, Morise A, Izumi K, Ohashi Y, Noda M, Kadowaki T; J-DOIT3 Study Group. Design of and rationale for the Japan Diabetes Optimal Integrated Treatment study for 3 major risk factors of cardiovascular diseases (J-DOIT3): a multicenter, open-label, randomized, parallel-group trial. BMJ Open Diabetes Res Care. 2016 Jan 25;4(1):e000123. doi: 10.1136/bmjdrc-2015-000123. eCollection 2016.
PubMed 26843962
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- (Intervention Study) A Randomized Controlled Study of the Intensive Therapy and the Conventional Therapy for the Suppression of the Vascular Complications in the Type 2 Diabetic Patients (Follow-up Study) A Randomized Controlled Study Comparing Intensive Therapy and Conventional Therapy in the Reduction of Vascular Complications in Type 2 Diabetic Patients: A Follow-up Study After Intervention
- ClinicalTrials.gov ID
- NCT00300976
- Acronym / sponsor ID
- J-DOIT3 / J-DOIT3
- Conditions
- Cardiovascular Diseases, Diabetes Mellitus, Type 2
- Keywords
- Blood glucose, Blood pressure, Lipids
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,542 participants (actual)
- Lead sponsor
- Japan Foundation for the Promotion of International Medical Research CooperationUniversity, hospital or other
- Collaborators
- Japan Diabetes Foundation
- Study start
- May 2006 (actual)
- Primary completion
- Mar 2016 (actual)
- Study completion
- Jun 2021 (estimated)
- First posted
- 10 Mar 2006 (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.
(Intervention study) The objective of the study is to confirm the superiority of the intensive therapy to the conventional therapy concerning the prevention of the incidence or exacerbation of vascular complications caused by diabetes mellitus (DM) by a randomized controlled study in patients with type 2 DM.
(Follow-up study) The objective of the follow-up study is to evaluate the long-term efficacy of intensive versus conventional therapy in the effect on mortality and the prevention of the incidence or exacerbation of vascular complications caused by diabetes mellitus through a post-intervention follow-up research conducted after the multi-center, open-label, randomized parallel-group study comparing the efficacy of intensive versus conventional therapy in type 2 diabetic patients.
Detailed description
(Intervention study) The objective of the study is to confirm the superiority of the intensive therapy to the conventional therapy concerning the prevention of the incidence or exacerbation of vascular complications caused by diabetes mellitus by a randomized controlled study in patients with type 2 DM. The primary outcome measure is occurrence of myocardial infarction, coronary bypass surgery, percutaneous transluminal coronary angioplasty, stroke, carotid endarterectomy, percutaneous transluminal cerebral angioplasty, carotid artery stenting, or death.
(Follow-up study) The objective of the follow-up study is to evaluate the long-term efficacy of intensive versus conventional therapy in the effect on mortality and the prevention of the incidence or exacerbation of vascular complications caused by diabetes mellitus through a post-intervention follow-up research conducted after the multi-center, open-label, randomized parallel-group study comparing the efficacy of intensive versus conventional therapy in type 2 diabetic patients. The primary endpoint is identical to that in the intervention study. In addition, overall survivalall-cause mortality will be evaluated as a key secondary endpoint.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- (Intervention study) A multi-center, open-label, randomized controlled study, which compared the efficacy of intensive therapy and conventional therapy in type 2 diabetic patients (Follow-up study) A prospective cohort study with a 5-year long-term follow-up period
| Arm | Type | Receives |
|---|---|---|
| Intensive therapy | Experimental | Behavioral: Lifestyle consultation: weight control, diet, exercise |
| Conventional therapy | Active comparator | Behavioral: Lifestyle consultation: weight control, diet, exercise |
Who may qualify
- Ages
- 45 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects were considered eligible if they were 45 years old or older but younger than 70 years old at study entry, had type 2 diabetes and met both "(1) and (2)" or both "(1) and (3)" described below. [Note: Those who met all three "(1), (2) and (3)" were also considered eligible for inclusion.](1) Glycemic control Those with HbA1c 6.9% or greater despite treatment with any of the three regimens given below. Diet and exercise therapy alone, Diet and exercise therapy plus 1 oral anti-diabetic drug, Diet and exercise therapy plus, GI and 1 other oral anti-anti-diabetic drug (2) Blood pressure control Those with the following casual blood pressure (BP) level as measured on an outpatient basis, Systolic BP 140 mmHg or diastolic BP 90 mmHg while not on an antihypertensive agent, Systolic BP 130 mmHg or diastolic BP 80 mmHg while on 1 or 2 ARB, ACEI or long-acting CCB Those receiving antihypertensive agents other than ARB, ACEI or long-acting CCB were not eligible for study entry, with the exception of those who were receiving these agents for other purposes than blood pressure lowering. (3) Lipid metabolism Those with the following fasting lipid levels while not on a lipid-lowering agent LDL-cholesterol, 120 mg/dL (as calculated by using the Friedewald formula) Triglycerides, 150 mg/dL HDL-cholesterol, < 40 mg/dL Subjects receiving 1 lipid-lowering agent were judged eligible for study entry if they met any of the above criteria. However, care needs to be taken to ensure that those on fibrates discontinue the fibrate treatment at the start of the study when they are assigned to the intensive therapy arm.
- Of the subjects in the randomized controlled study comparing intensive therapy and conventional therapy in type 2 diabetic patients (J-DOIT3), those who provide written informed consent to participate in the follow-up study will be enrolled regardless of completion or discontinuation from the randomized controlled study (If the subject is unable to provide informed consent for any reason, consent from his/her legal representative is allowed).
Key exclusion criteria (3 listed)
- 1. Those with poorly controlled hypertension despite pharmacological therapy (systolic BP 200 mmHg or diastolic BP 120 mmHg) 2. Those on insulin therapy 3. Those with non-diabetic renal disease 4. Those in whom type 1 and other diabetes due to pathogenic mechanisms other than those associated with type 2 diabetes is strongly suspected 5. Those who tested anti-GAD antibody-positive 6. Those with LDL-cholesterol 200 mg/dL 7. Those suspected of having secondary hypertension other than renal parenchymal hypertension 8. Those suspected of having hereditary lipid disorder with a strong family history of lipid metabolic disorder 9. Those who were receiving antihypertensive agents other than ARB, ACEI, long-acting CCB, except where they were receiving these agents for other purposes than blood pressure lowering 10. Those who were receiving 3 or more antihypertensive agents (i.e., ARB, ACEI, and long-acting CCB), except where they were receiving these agents for other purposes than blood pressure lowering 11. Those with more serious retinopathy than proliferative retinopathy 12. Renal failure (serum Cr: 2.0 mg/dL in men; 1.5 mg/dL in women) 13. Those with a history of cardiac failure or those with cardiac failure 14. Those who were pregnant or potentially pregnant 15. Those who met any of the following criteria and who had BNP 100 pg/mL, Myocardial infarction, Angina pectoris (or a history of disease), History of coronary artery bypass graft (CABG), History of percutaneous coronary angioplasty (PTCA), Other cardiac disease, ECG findings of left ventricular hyperplasia, Abnormal ECG findings (excluding isolated extrasystole or right bundle branch block [RBBB]) 16. Those judged by the physician in charge to be ineligible for study entry
- (Follow-up study)
- A subject who is assessed as ineligible by the investigator will be excluded from the follow-up study
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 |
|---|---|---|
| Lifestyle consultation: weight control, diet, exerciseBehavioral: Lifestyle modification including weight control, with the goal of BMI 22. Drug: Drugs are added in a stepwise manner to control blood glucose, blood pressure and lipid metabolism, using mainly hypoglycemic drugs, ACEI/ARB and statins, respectively. Management goals are: HbA1c < 6.2%, BP < 120/75 mmHg, HDL-C 40 mg/dL , LDL-C < 80 mg/dL, TG < 120 mg/dL. Follow-up study (Not provided) | Behavioural | Intensive therapy |
| Lifestyle consultation: weight control, diet, exerciseBehavioral and Drug: The physician in charge is to administer appropriate therapy in accordance with the Guidelines. Follow-up study (Not provided) | Behavioural | Conventional therapy |
Primary outcome
The occurrence of myocardial infarction, coronary bypass surgery, percutaneous transluminal coronary angioplasty, stroke, carotid endarterectomy, percutaneous transluminal cerebral angioplasty, carotid artery stenting, or death
Time frame: Every 12 months, at the end of the study.
5 secondary outcomes
Occurrence of myocardial infarction, stroke or death
Time frame: Every 12 months, at the end of the study.
Onset or progression of nephropathy
Time frame: Every 6 months, at the end of the study.
Lower limb vascular events (amputation or revascularization of lower limb)
Time frame: Every 12 months, at the end of the study.
Onset or progression of retinopathy
Time frame: Every 12 months, at the end of the study.
All-cause mortality (deaths due to any cause)
Time frame: Every 12 months, at the end of the study.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2017.
- Derived from this study: PubMed 42912779Noda M, Ueki K, Sasako T, Ishizuka N, Miyake K, Miyoshi K, Aoyama T, Okazaki Y, Ohashi Y, Yamauchi T, Kadowaki T; J-DOIT3 Study Group. Search for the glycated hemoglobin target minimizing mortality among people with type 2 diabetes with rare incidence of treatment-related severe hypoglycemia - Epidemiologic analysis of J-DOIT3 randomized controlled trial. PLoS One. 2026 Oct 23;21(10):e0360295. doi: 10.1371/journal.pone.0360295. eCollection 2026.
- Derived from this study: PubMed 41129145Sasako T, Ueki K, Miyoshi K, Miyake K, Aoyama T, Okazaki Y, Ishizuka N, Yamauchi T, Noda M, Kadowaki T; J-DOIT3 Study Group. Effect of a Multifactorial Intervention on Retinopathy in People With Type 2 Diabetes: A Secondary Analysis of the J-DOIT3 Randomized Clinical Trial. JAMA Ophthalmol. 2025 Dec 1;143(12):989-997. doi: 10.1001/jamaophthalmol.2025.3819.
- Derived from this study: PubMed 33491087Sasako T, Ueki K, Miyake K, Okazaki Y, Takeuchi Y, Ohashi Y, Noda M, Kadowaki T. Effect of a Multifactorial Intervention on Fracture in Patients With Type 2 Diabetes: Subanalysis of the J-DOIT3 Study. J Clin Endocrinol Metab. 2021 Apr 23;106(5):e2116-e2128. doi: 10.1210/clinem/dgab013.
- Derived from this study: PubMed 29079252Ueki K, Sasako T, Okazaki Y, Kato M, Okahata S, Katsuyama H, Haraguchi M, Morita A, Ohashi K, Hara K, Morise A, Izumi K, Ishizuka N, Ohashi Y, Noda M, Kadowaki T; J-DOIT3 Study Group. Effect of an intensified multifactorial intervention on cardiovascular outcomes and mortality in type 2 diabetes (J-DOIT3): an open-label, randomised controlled trial. Lancet Diabetes Endocrinol. 2017 Dec;5(12):951-964. doi: 10.1016/S2213-8587(17)30327-3. Epub 2017 Oct 24.
- Derived from this study: PubMed 26843962Ueki K, Sasako T, Kato M, Okazaki Y, Okahata S, Katsuyama H, Haraguchi M, Morita A, Ohashi K, Hara K, Morise A, Izumi K, Ohashi Y, Noda M, Kadowaki T; J-DOIT3 Study Group. Design of and rationale for the Japan Diabetes Optimal Integrated Treatment study for 3 major risk factors of cardiovascular diseases (J-DOIT3): a multicenter, open-label, randomized, parallel-group trial. BMJ Open Diabetes Res Care. 2016 Jan 25;4(1):e000123. doi: 10.1136/bmjdrc-2015-000123. eCollection 2016.
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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.
Takashi Kadowaki principal investigator
Tokyo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Cardiovascular Diseases and Diabetes Mellitus, Type 2, run by Japan Foundation for the Promotion of International Medical Research Cooperation at 1 site in Japan.
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 3 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: status not confirmed, as of the sponsor's last update on 3 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. 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?
Results are not available in the source record.
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?
The occurrence of myocardial infarction, coronary bypass surgery, percutaneous transluminal coronary angioplasty, stroke, carotid endarterectomy, percutaneous transluminal cerebral angioplasty, carotid artery stenting, or death (time frame: Every 12 months, at the end of the study.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00300976, which also lists 5 linked publications.
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 3 Aug 2017.