Pioglitazone Special Drug Use Surveillance "Metabolic Syndrome in Patients With Type 2 Diabetes Mellitus"
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|ClinicalTrials.gov Identifier: NCT02002975|
Recruitment Status : Completed
First Posted : December 6, 2013
Last Update Posted : December 6, 2013
|Condition or disease||Intervention/treatment|
|Type 2 Diabetes Mellitus||Drug: Pioglitazone|
This is a special drug use surveillance on long-term use of pioglitazone (Actos Tablets) in patients with type 2 diabetes mellitus, designed to determine the onset of new cerebral and cardiovascular events and changes in metabolic syndrome parameters, and to analyze the association between patient baseline characteristics, including any metabolic syndrome-related risk factors, and the onset of new cerebral and cardiovascular events in an exploratory setting.
Participants will be patients with type 2 diabetes mellitus. The planned sample size is 20,000.
The usual adult dosage is 15 to 30 mg of pioglitazone administered orally once daily before or after breakfast.
|Study Type :||Observational|
|Actual Enrollment :||18197 participants|
|Official Title:||Actos Tablets Special Drug Use Surveillance "Metabolic Syndrome in Patients With Type 2 Diabetes Mellitus"|
|Study Start Date :||October 2007|
|Actual Primary Completion Date :||June 2013|
|Actual Study Completion Date :||June 2013|
U.S. FDA Resources
Pioglitazone 15 to 30 mg
administered orally once daily before or after breakfast for 3 years.
Other Name: ACTOS
- Frequency of new cerebral and cardiovascular events [ Time Frame: 3 years ]Cerebral and cardiovascular events include the following: - Sudden death - Cerebral infarction, cerebral hemorrhage, subarachnoid hemorrhage - Acute myocardial infarction, angina pectoris requiring intervention or hospitalization for treatment - Cardiac failure requiring hospitalization for treatment - Atrial fibrillation - Aortic dissection
- Changes in metabolic syndrome parameters [i.e., waist circumference, body weight, blood pressure, Glycosylated Hemoglobin (HbA1c), fasting triglyceride, high-density lipoprotein (HDL) cholesterol] [ Time Frame: 3 years ]
- Association between patient baseline characteristics, including any metabolic syndrome-related risk factors, and onset of new cerebral and cardiovascular events [ Time Frame: 3 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02002975
|Study Chair:||Postmarketing Group Manager||Takeda|