Pioglitazone Tablets Special Drug Use Surveillance Combined Use of Insulin Products / Long-term Treatment

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the safety and efficacy of long-term treatment with pioglitazone (Actos Tablets) in the routine clinical setting in combination with an insulin product in patients with type 2 diabetes mellitus who responded inadequately when using an insulin product in addition to diet therapy and exercise therapy.

Detailed Description
-----------------
This is a special drug use surveillance on long-term use of newly co-administered pioglitazone tablets (Actos Tablets) as part of routine medical care in patients with type 2 diabetes mellitus who have poorly controlled blood glucose when using an insulin product in addition to diet therapy and exercise therapy; this survey is designed to determine the safety and efficacy of long-term use of pioglitazone tablets (Actos Tablets) in the routine clinical setting in combination with an insulin product (the planned sample size, 1000.) The usual adult dosage is 15 mg of pioglitazone administered orally once daily before or after breakfast. Dose adjustment will be made according to gender, age, and symptoms with an upper limit of 30 mg.

Official Title
-----------------
Actos Tablets Special Drug Use Surveillance Combined Use of Insulin Products / Long-term Treatment

Conditions
-----------------
Type 2 Diabetes Mellitus

Intervention / Treatment
-----------------
* Drug: Pioglitazone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants with type 2 diabetes mellitus assumed to have insulin resistance who responded inadequately when using an insulin product in addition to diet therapy and exercise therapy who meet the following criteria at enrollment. Participants treated with an insulin product for at least 4 weeks Participants who started Actos Tablets for the first time after the start of an insulin product Participants likely to be available for a 52-week observation and evaluation after the start of co-administration of Actos Tablets Exclusion Criteria: Participants with contraindications to Actos Tables and insulin products treatment
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pioglitazone<br>Pioglitazone 15 mg to 30 mg, orally, once daily | Drug: Pioglitazone<br>* Pioglitazone Tablets<br>* Other names: Actos;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Experience at Least One Adverse Drug Reactions (ADRs) | ADRs are defined as adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment. AEs are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. | Up to Week 52 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Fasting Blood Glucose |  | Baseline and Week 12, 24, 36, 52, and final assessment (up to Week 52) | 
| Change From Baseline in Glycosylated Hemoglobin (HbA1c) |  | Baseline and Week 12, 24, 36, 52, and final assessment (up to Week 52) | 
| Change From Baseline in Fasting Triglycerides |  | Baseline and Week 12, 24, 36, 52, and final assessment (up to Week 52) | 
| Change From Baseline in HDL Cholesterol |  | Baseline and Week 12, 24, 36, 52, and final assessment (up to Week 52) | 
| Change From Baseline in LDL Cholesterol |  | Baseline and Week 12, 24, 36, 52, and final assessment (up to Week 52) | 
| Number of Participants Who Received Specific Daily Dose of Insulin Product at Each Time Points | Number of participants who received study drug and specific daily dose of insulin product during the survey was reported. Daily dose of insulin was categorized by < 30 units, >= 30 and < 60 units, >= 60 and < 90 units, >= 90 units at each time points. | Baseline, Week 52, and final assessment (up to Week 52) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Drug therapy