NCT00300976

Brief 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. (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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,542

participants targeted

Target at P75+ for not_applicable cardiovascular-diseases

Timeline
Completed

Started May 2006

Longer than P75 for not_applicable cardiovascular-diseases

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 8, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 10, 2006

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2006

Completed
9.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
5.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

August 3, 2017

Status Verified

August 1, 2017

Enrollment Period

9.8 years

First QC Date

March 8, 2006

Last Update Submit

August 2, 2017

Conditions

Cardiovascular DiseasesDiabetes Mellitus, Type 2

Keywords

Blood glucoseBlood pressureLipids

Outcome Measures

Primary Outcomes (1)

  • The occurrence of myocardial infarction, coronary bypass surgery, percutaneous transluminal coronary angioplasty, stroke, carotid endarterectomy, percutaneous transluminal cerebral angioplasty, carotid artery stenting, or death

    Every 12 months, at the end of the study.

Secondary Outcomes (5)

  • Occurrence of myocardial infarction, stroke or death

    Every 12 months, at the end of the study.

  • Onset or progression of nephropathy

    Every 6 months, at the end of the study.

  • Lower limb vascular events (amputation or revascularization of lower limb)

    Every 12 months, at the end of the study.

  • Onset or progression of retinopathy

    Every 12 months, at the end of the study.

  • All-cause mortality (deaths due to any cause)

    Every 12 months, at the end of the study.

Other Outcomes (6)

  • Development of severe hypoglycemia (requiring assistance from another person and/or hospitalization)

    Every 12 months, at the end of the study.

  • Hospitalization for heart failure

    Every 12 months, at the end of the study.

  • Development of malignant neoplasms

    Every 12 months, at the end of the study.

  • +3 more other outcomes

Study Arms (2)

Intensive therapy

EXPERIMENTAL
Behavioral: Lifestyle consultation: weight control, diet, exercise

Conventional therapy

ACTIVE COMPARATOR
Behavioral: Lifestyle consultation: weight control, diet, exercise

Interventions

Lifestyle consultation: weight control, diet, exerciseBEHAVIORAL

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)

Intensive therapy

Eligibility Criteria

Age45 Years - 69 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • \. 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)
  • 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).
  • A subject who is assessed as ineligible by the investigator will be excluded from the follow-up study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Tokyo

Tokyo, 113-8655, Japan

Location

Related Publications (4)

  • Sasako 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.

    PMID: 41129145DERIVED

  • Sasako 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.

    PMID: 33491087DERIVED

  • Ueki 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.

    PMID: 29079252DERIVED

  • Ueki 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.

    PMID: 26843962DERIVED

MeSH Terms

Conditions

Cardiovascular DiseasesDiabetes Mellitus, Type 2

Interventions

DietExercise

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Takashi Kadowaki

    Tokyo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: (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
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 8, 2006

First Posted

March 10, 2006

Study Start

May 1, 2006

Primary Completion

March 1, 2016

Study Completion

June 1, 2021

Last Updated

August 3, 2017

Record last verified: 2017-08

Locations

JP(1)