UMIN-CTR Clinical Trial

Public title

Post-marketing Clinical Trial of Pioglitazone - A Study of Preventive Effects on the Onset and Recurrence of Macrovascular Events -

Acronym

Post-marketing Clinical Trial of Pioglitazone - A Study of Preventive Effects on the Onset and Recurrence of Macrovascular Events -

Scientific Title

Post-marketing Clinical Trial of Pioglitazone - A Study of Preventive Effects on the Onset and Recurrence of Macrovascular Events -

Scientific Title:Acronym

Post-marketing Clinical Trial of Pioglitazone - A Study of Preventive Effects on the Onset and Recurrence of Macrovascular Events -

Region

Japan

Condition

Type2 Diabetes

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The preventive effects of pioglitazone on the onset and recurrence of macrovascular events in type 2 diabetes mellitus patients were exploratory investigated using pioglitazone-untreated patients as the control group.

Basic objectives2

Others

Basic objectives -Others

[1] Using the carotid intima-media thickness (IMT) as the index, the prevention of arteriosclerosis by pioglitazone in type 2 diabetes mellitus patients was investigated using pioglitazone-untreated patients as the control group.
[2] The long-term safety of pioglitazone in type 2 diabetes mellitus patients was investigated.

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Time to the onset of any of the following macrovascular events from the start of the treatment period (Week 0):
[1]Death (endogenous)
[2]Myocardial infarction (non-fatal)
[3]Silent myocardial infarction
[4]Acute coronary syndrome
[5]Coronary intervention (percutaneous vascular intervention, coronary artery bypass surgery)
[6]Cerebrovascular disorder (excluding TIA)
[7]Lower limb (leg down to the ankle) amputation
[8]Lower limb bypass surgery or angioplasty
[9]Onset or worsening of angina pectoris
[10]Arteriosclerosis obliterans

Key secondary outcomes

Changes in IMT, occurrence of adverse events (subjective and objective concurrent symptoms, abnormal changes in laboratory values)

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Blinding

Open -but assessor(s) are blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

In addition to their baseline treatment, Pioglitazone 15 to 30 mg was orally administered once daily before or after breakfast.The dosage was adjusted according to the patient's sex, age and symptoms, up to the maximum daily dose of 45 mg.Concerning the use of pioglitazone in women or elderly patients, it was recommended to start treatment at 15 mg once daily. When it became necessary to start insulin therapy, the treatment with pioglitazone was to be suspended. If the insulin therapy was discontinued thereafter, the treatment with pioglitazone was to be resumed again if possible.The duration of treatment was set at 2.5 to 4 years.

Interventions/Control_2

Their baseline treatment was kept.

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

35

years-old

<=

Age-upper limit

75

years-old

>

Gender

Male and Female

Key inclusion criteria

(1)Subjects whose HbA1c was 6.5% or more
(2)Subjects who met at least two of the following conditions
1)Subjects with hypertension (those who met one of the following conditions)
[1]Subjects who were diagnosed with hypertension and who had been on drug therapy
[2]Subjects who had not received drug therapy and showed a systolic blood pressure of 140 mmHg or more ,or a diastolic blood pressure of 90 mmHg or more at rest in the sitting position.
2)Subjects with hyperlipidemia (including abnormality of lipid metabolism) (those who met one of the following conditions)
[1]Subjects who were diagnosed with hyperlipidemia and who had been on drug therapy
[2] Subjects who had not received drug therapy and showed a total cholesterol of 240 mg/dL or more, LDL-cholesterol of 160 mg/dL or more, or HDL-cholesterol of 40 mg/dL or less.
3)Subjects with a smoking habit (at least one cigarette/day)
4) Obesity (BMI 25 or more)

Key exclusion criteria

(1)Subjects who were diagnosed with type 1 diabetes mellitus
(2)Subjects with a BMI of <22 and a fasting IRI of <5 mU/mL
(3)Subjects who required insulin therapy to control the blood glucose of diabetes mellitus, or who were on insulin therapy
(4)Subjects with a history of hepatic function disorder due to the use of thiazolidinediones (e.g., troglitazone and pioglitazone)
(5)Subjects currently on pioglitazone therapy
(6)Subjects who had cardiac failure or a history thereof
(7)Subjects with cardiovascular disorders (those who met the following conditions)
1)Subjects with onset of myocardial infarction within 6 months
2)Subjects who received hospital treatment for acute coronary syndrome within 3 months
3) Subjects who underwent coronary artery bypass surgery or percutaneous transluminal coronary angioplasty within 6 months
(8)Subjects with the complication of severe arrhythmia
(9)Subjects with cerebrovasculardisorders [those with onset of cerebrovascular disorder (excluding TIA)]
(10)Subjects who needed management of their blood glucose by insulin injection, due to severe infection, before or after operation, or serious traumatic injury
(11)Subjects with scheduled coronary artery bypass surgery, percutaneous transluminal coronary angioplasty, or surgery for leg ischemia

Target sample size

550

Name of lead principal investigator

1st name
Middle name
Last name	Kohei Kaku

Organization

Kawasaki Medical School

Division name

Diabetes and Endocrine Division, Department of Medicine

Zip code

Address

577 Matsushima Kurashiki-shi, Okayama,Japan.

TEL

Email

Name of contact person

1st name
Middle name
Last name

Organization

Takeda Pharmaceutical Company Limited

Division name

Contact for Clinical Trial Infomation

Zip code

Address

TEL

Homepage URL

https://www.takeda.co.jp/contact/form/jp/form/

Email

Institute

Takeda Pharmaceutical Company Limited

Institute

Department

Personal name

Organization

Takeda Pharmaceutical Company Limited

Organization

Division

Category of Funding Organization

Profit organization

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

2008

Year

09

Month

10

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

Completed

Date of protocol fixation

2001

Year

12

Month

17

Day

Date of IRB

Anticipated trial start date

2002

Year

04

Month

01

Day

Last follow-up date

2006

Year

06

Month

01

Day

Date of closure to data entry

2006

Year

08

Month

01

Day

Date trial data considered complete

2006

Year

08

Month

01

Day

Date analysis concluded

2006

Year

10

Month

01

Day

Other related information

Registered date

2008

Year

09

Month

09

Day

Last modified on

2009

Year

01

Month

22

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001553