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Recruitment status
Unique ID issued by UMIN UMIN000000947
Receipt No. R000001083
Scientific Title Reversal of diabetes and prevention of arteriosclerosis in type 2 diabetic patients with oral antidiabetic agents
Date of disclosure of the study information 2007/12/14
Last modified on 2007/12/14

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Basic information
Public title Reversal of diabetes and prevention of arteriosclerosis in type 2
diabetic patients with oral antidiabetic agents
Acronym Pioglitazone and Sulfonylurea Remission from T2DM development and anti-atherosclerosis in Japan : PREVENT-J
Scientific Title Reversal of diabetes and prevention of arteriosclerosis in type 2
diabetic patients with oral antidiabetic agents
Scientific Title:Acronym Pioglitazone and Sulfonylurea Remission from T2DM development and anti-atherosclerosis in Japan : PREVENT-J
Region
Japan

Condition
Condition Type2 Diabetes Mellitus
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The study is designed to examine whether an oral antidiabetic agent (comparing two types of drugs) would induce remission in diabetes and prevent atherosclerosis in patients with type 2 diabetes within 10 years of diagnosis, who have HbA1c of less than 7.5%.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes -Duration of the period during which the patients's HbA1c level continued to be less thna 7.0% after completion of dosing (i.e. the observation period of 1.5 yrs) (Kaplan-Meier method).
-Duration of dosing (i.e. during the 1.5 years after registration) in which the
patient's HbA1c level continued to be less than 7.5% (Kaplan-Meier method).
-Indices for atherosclerosis: hsCRP, urinary 8-OHdG, and adiponectin.
Key secondary outcomes -Proportion of patients who achieved an HbA1c level of less than 6.5% after 1.5 years of dosing (Kaplan-Meier method).
-Duration of the period in which the patient's HbA1c levels continued to be less than 5.8% (Kaplan-Meier method).
-Cardiovascular events (Kaplan-Meier method)
-Urinary microalbumin (adjusted for creatinine)
-Insulin and proinsulin
-Changes in lipids: TC, TG, HDL-C, LDL-C
-Changes in blood pressure
-Changes in liver tests: ALT, AST, g-GTP, and LDH).
Safety: edema, hypoglycemia, and others.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation YES
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Diet and exercise intervention
Interventions/Control_2 Pioglitazone (15-30 mg/day)
Interventions/Control_3 Sulfonylureas
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
70 years-old >
Gender Male and Female
Key inclusion criteria -Diagnosis of type 2 diabetes.
-Those who have received monotherapy with either diet/exercise, an a-GI, a D-phenylalanine derivative (glinide), or a biguanide.
-Aged 20 or over and less than 70.
-Those who have had type 2 diabetes for less than 10 years.
-HbA1C of less than 7.5%.
-Outpatients or inpatients.
-Male or female.
-Microvascular complications limited to single retinopathy, neuropathy, stage 2 nephropathy.
Key exclusion criteria -Heart failure or history of heart failure.
-EF of less than 40%.
-History of adverse reactions to a thiazolidine derivative or concerns about safety.
-Severe hepatic dysfunction.
-Severe renal dysfunction.
-History of cardiovascular disease.
-Current treatment with a sulfonylurea drug.
-Current treatment with a thiazolidine derivative.
-Current treatment with insulin.
-Those whom the principle investigator or other investigators consider unsuitable.
Target sample size 500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kouhei Kaku, MD
Organization Kawasaki Medical School
Division name Department of Internal Medicine
Zip code
Address 577 Matsushima, Kurashiki, Okayama 701-0192, Japan.
TEL 086-464-1046
Email

Public contact
Name of contact person
1st name
Middle name
Last name Mitsuru Hashiramoto, MD
Organization Kawasaki Medical School
Division name Department of Internal Medicine
Zip code
Address 577 Matsushima, Kurashiki, Okayama 701-0192, Japan.
TEL 086-464-1046
Homepage URL http://www.prevent-j.jp
Email hashira@med.kawasaki-m.ac.jp

Sponsor
Institute PREVENT-J Study Steering Committee
Institute
Department

Funding Source
Organization Japan Cardiovascular Research Foundation
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2007 Year 12 Month 14 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status
Date of protocol fixation
2007 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date
2007 Year 12 Month 01 Day
Last follow-up date
2011 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2007 Year 12 Month 14 Day
Last modified on
2007 Year 12 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001083

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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