UMIN-CTR Clinical Trial

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

Type2 Diabetes Mellitus

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO

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

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.

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

Dynamic allocation

YES

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

PREVENT-J Study Steering Committee

Institute

Department

Personal name

Organization

Japan Cardiovascular Research Foundation

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2007

Year

12

Month

14

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2007

Year

12

Month

14

Day

Last modified on

2007

Year

12

Month

14

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001083