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

UMIN ID: UMIN000001363

Registered date:10/09/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Type2 Diabetes
• Date of first enrollment: 2002/04/01
• Target sample size: 550
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

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.
Their baseline treatment was kept.

Outcome(s)

• Primary Outcome: 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
• Secondary Outcome: Changes in IMT, occurrence of adverse events (subjective and objective concurrent symptoms, abnormal changes in laboratory values)

Key inclusion & exclusion criteria

• Age minimum: 35years-old
• Age maximum: 75years-old
• Gender: Male and Female
• Exclude 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

Related Information

• Primary Sponsor: Takeda Pharmaceutical Company Limited
• Source(s) of Monetary Support: Takeda Pharmaceutical Company Limited