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

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00301392
• Other study ID #: J-PREDICT
• Status: Completed
• Phase: Phase 4
• First received: March 5, 2006
• Last updated: September 5, 2013
• Start date: April 2006
• Est. completion date: June 2012

Study information

• Verified date: September 2013
• Source: Tokyo University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

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

Description:

Diabetes mellitus and its complications are major health problems globally. People with impaired glucose tolerance (IGT) are at high risk of developing diabetes. It is therefore important to focus on preventing diabetes in individuals with IGT. HMG-CoA reductase inhibitors (statins) are widely used for hypercholesterolemia, one of the most frequent metabolic disorders. However, there is no direct evidence to whether statins are beneficial for preventing diabetes. This study is designed to compare the efficacy of life-style modification versus life-style modification with pitavastatin (a statin) administration, in individuals with IGT.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1240
• Est. completion date: June 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 74 Years

Eligibility

Inclusion Criteria:

Inclusion Criteria for the screening test (within 6 months before screening):

• LDL-cholesterol 100-159 mg/dl and/or total cholesterol 180-239 mg/dl

• At least one of the following:

1. 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%

2. At least two of the following risk factors for impaired glucose tolerance:

1. Second degree relative with diabetes

2. BMI >= 24 kg/m2

3. Systolic blood pressure >=130 mmHg, and/or diastolic blood pressure >= 85 mmHg, and/or receiving treatment for hypertension

4. 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

Inclusion Criteria for the entry (Confirmed by screening test):

-Impaired glucose tolerance by 75g oral glucose tolerance test (fasting plasma glucose <126 mg/dl and 2-h plasma glucose 140-199 mg/dl)

Exclusion Criteria:

• 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)

1. History of hypersensitivity to any of the ingredients of the product

2. Severe hepatic disorder or biliary atresia

3. Receiving cyclosporine

4. Pregnant women, women suspected of being pregnant, or lactating women

5. Patients receiving fibrates who also have laboratory evidence of abnormal renal function

• Familial hypercholesterolemia

• Drug abuse, alcoholism

• Individuals who are ineligible in the opinion of the investigator

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetes Mellitus
• Glucose Intolerance

Intervention

Other:
• life-style intervention
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.

Drug:
• Life style interventions plus concomitant use of pitavastatin.
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).

Locations

Country	Name	City	State
Japan	The University of Tokyo, Graduate School of Medicine	Bunkyo-ku	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Tokyo University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative incidence of diabetes based on 1 positive OGTT or fasting glucose levels		from April, 2006 to end of March, 2012	No
Secondary	Incidence of newly developed diabetes		from April, 2006 to end of March, 2012	No
Secondary	Cumulative incidence of diabetes based on clinical diagnosis.	Cumulative incidence of diabetes based on clinical diagnosis defined as at least one of the following:(1) Typical symptoms of diabet plus 1 positive OGTT or fasting glucose levels, (2)HbA1c>=6.5% plus 1 positive OGTT or fasting glucose levels, (3)2 positive OGTT or fasting glucose levels.	from April, 2006 to end of March, 2012	No
Secondary	Cumulative incidence of newly developed diabetes based on 1 positive OGTT or fasting glucose levels	Cumulative incidence of newly developed diabetes based on 1 positive OGTT or fasting glucose levels (from the first administration of the study drug after the randomization)	from April, 2006 to end of March, 2012	No
Secondary	Time until development of diabetes; Improvement in glucose tolerance		from April, 2006 to end of March, 2012	No
Secondary	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	No
Secondary	Incidence of coronary heart disease (myocardial infarction, angina, coronary revascularization)		from April, 2006 to end of March, 2012	No
Secondary	Incidence of coronary heart disease plus cerebral infarction		from April, 2006 to end of March, 2012	No
Secondary	LDL-cholesterol		from April, 2006 to end of March, 2012	No
Secondary	HDL-cholesterol		from April, 2006 to end of March, 2012	No
Secondary	Triglyceride		from April, 2006 to end of March, 2012	No
Secondary	RLP-cholesterol		from April, 2006 to end of March, 2012	No
Secondary	Adiponectin		from April, 2006 to end of March, 2012	No
Secondary	High sensitive CRP		from April, 2006 to end of March, 2012	No
Secondary	Asymmetrical dimethyl arginine (ADMA)		from April, 2006 to end of March, 2012	No
Secondary	Urinary 8-OHd		from April, 2006 to end of March, 2012	No
Secondary	Fasting plasma glucose		from April, 2006 to end of March, 2012	No
Secondary	2-h plasma glucose during 75g oral glucose tolerance test		from April, 2006 to end of March, 2012	No
Secondary	HbA1c		from April, 2006 to end of March, 2012	No
Secondary	Insulin		from April, 2006 to end of March, 2012	No
Secondary	HOMA-R		from April, 2006 to end of March, 2012	No
Secondary	HOMA-ß		from April, 2006 to end of March, 2012	No
Secondary	Insulinogenic index		from April, 2006 to end of March, 2012	No
Secondary	Time until dropout		from April, 2006 to end of March, 2012	No
Secondary	Number of adverse events		from April, 2006 to end of March, 2012	No