Japan Prevention Trial of Diabetes by Pitavastatin in Patients With Impaired Glucose Tolerance (J-PREDICT)

NCT00301392 | Completed Phase 4

• 1 other identifier: J-PREDICT
• Study Type: interventional
• Target: 1,240
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the effects of pitavastatin for preventing diabetes in a population with impaired glucose tolerance.

Conditions

Diabetes Mellitus; Glucose Intolerance

Keywords

Glucose intolerance; Diabetes mellitus; Statins,HMG-CoA

Outcome Measures

Primary Outcomes (1)

• Cumulative incidence of diabetes based on 1 positive OGTT or fasting glucose levels

  from April, 2006 to end of March, 2012

Secondary Outcomes (24)

• Incidence of newly developed diabetes

  from April, 2006 to end of March, 2012

• Cumulative incidence of diabetes based on clinical diagnosis.

  from April, 2006 to end of March, 2012

• Cumulative incidence of newly developed diabetes based on 1 positive OGTT or fasting glucose levels

  from April, 2006 to end of March, 2012

• Time until development of diabetes; Improvement in glucose tolerance

  from April, 2006 to end of March, 2012

• Incidence of any cardiovascular disease (myocardial infarction, angina, congestive heart disease, coronary revascularization, cerebral hemorrhage, cerebral infarction.

  from April, 2006 to end of March, 2012

Study Arms (1)

Pitavastatin

OTHER

Administration of Pitavastatin

Other: life-style intervention; Drug: Life style interventions plus concomitant use of pitavastatin.

Interventions

life-style intervention OTHER

As the life-style interventions aiming to reduce the major risks of developing diabetes mellitus, instruct the following four items:(1)set diet right, (2)maintain normal weight,(3)improve physical activity,(4)normalize smoking and alcohol drinking.

Pitavastatin

Life style interventions plus concomitant use of pitavastatin. DRUG

Once-daily dosing of pitavastatin 1 mg(1 tablet of Livalo Tab 1 mg), or 2mg(2 tablets of Livalo Tab 1mg or 1 tablet of Livalo Tab 2mg);Dosing period of pitavastatin should be 60 months.(max.84 months).

Pitavastatin

Eligibility Criteria

• Age: 30 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• LDL-cholesterol 100-159 mg/dl and/or total cholesterol 180-239 mg/dl
• At least one of the following:
• Fasting plasma glucose 100-125 mg/dl, and/or casual (non-fasting) plasma glucose 120-199 mg/dl, and/or HbA1c 5.5-6.0%
• At least two of the following risk factors for impaired glucose tolerance:
• Second degree relative with diabetes
• BMI \>= 24 kg/m2
• Systolic blood pressure \>=130 mmHg, and/or diastolic blood pressure \>= 85 mmHg, and/or receiving treatment for hypertension
• Triglyceride \>= 150 mg/dl, and/or HDL \< 40 mg/dl
• Written consent for participation in the study by their own volition after being provided sufficient explanation for the participation into this clinical trial
• Impaired glucose tolerance by 75g oral glucose tolerance test (fasting plasma glucose \<126 mg/dl and 2-h plasma glucose 140-199 mg/dl)

You may not qualify if:

• History of diabetes (except gestational diabetes)
• Fasting plasma glucose \>= 126 mg/dl , and/or 2-h plasma glucose \>= 200 mg/dl
• HbA1c \>= 6.5%
• Diabetic retinopathy
• Receiving with hormone replacement therapy
• Pancreatic diseases ( e.g. pancreatitis, pancreatectomy, pancreatic cancer), Endocrine diseases ( e.g. Cushing's syndrome, acromegaly, pheochromocytoma, aldosteronism, hyperthyroidism )
• Receiving statins, fibrates or anion exchange resins
• Cancer or suspected cancer
• History of gastrectomy
• History of myocardial infarction, angina, or heart failure (NYHA Class \>= III)
• Severe hypertension (SBP \>= 180 mmHg or DBP \>= 110 mmHg)
• Renal disease, including serum creatinine \>= 2.0 mg/dl
• Hepatic disease, including transaminase (ALT or AST) \>= 2 times the upper limit of normal
• Women hoping to become pregnant during the intended study period
• Contraindication or relative contraindication of Livalo® Tab(pitavastatin calcium)

Sponsors & Collaborators

• Tokyo University: lead

Study Sites (1)

The University of Tokyo, Graduate School of Medicine

Bunkyo-ku, Tokyo, 113-8655, Japan

Location

MeSH Terms

Conditions

Diabetes Mellitus; Glucose Intolerance

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperglycemia

Study Officials

• Takashi Kadowaki, MD,PhD

  Professor, Department of Metabolic Diseases, Graduate School of Medicine, the University of Tokyo.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 5, 2006
• First Posted: March 10, 2006
• Study Start: April 1, 2006
• Primary Completion: March 1, 2012
• Study Completion: June 1, 2012
• Last Updated: September 6, 2013

Record last verified: 2013-09

Locations

JP (1)