Efficacy of Pioglitazone in Patients With Inadequately Controlled Type 2 Diabetes Mellitus Treated With Stable Triple Oral Therapy (ADD)
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A 24-Week, Open Label, Phase IV Trial to Evaluate the Efficacy of Pioglitazone 30 mg in Patients With Inadequately Controlled Type 2 Diabetes Mellitus Treated With Stable Triple Oral Therapy of Metformin, Sulfonylurea, and Pioglitazone 15 Mg (ADD Trial)|
- Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24 [ Time Frame: Baseline and Week 24 ]The change from Baseline in glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) at Week 24.
- Change From Baseline in Fasting Plasma Glucose at Week 24 [ Time Frame: Baseline and Week 24 ]The change between the value of fasting serum glucose collected at Week 24 and fasting serum glucose collected at Baseline.
|Study Start Date:||January 2014|
|Study Completion Date:||October 2016|
|Primary Completion Date:||October 2016 (Final data collection date for primary outcome measure)|
Experimental: Pioglitazone 30 mg
Pioglitazone 30 mg tablets, orally, once daily, and metformin and sulfonylurea will be administered according to the prescribing information of the approved Korean label, for up to 24 weeks.
Other Name: ACTOS
The drug being tested in this study is called pioglitazone. Pioglitazone is being tested to treat glycemic control in adults with inadequately controlled type 2 diabetes mellitus. This study will look at glycemic control in people who take triple oral therapy of metformin, sulfonylurea, and pioglitazone 15 mg.
The study will enroll approximately 114 patients. All participants will be asked to take one pioglitazone tablet at the same time each day throughout the study as well as continuing their previous dose of metformin and sulfonylurea..
This multi-centre trial will be conducted in Korea. The overall time to participate in this study is up to 25 weeks. Participants will make 4 visits to the hospital or endocrinologist's office, and will be contacted by telephone 7 days after last dose of study drug for a follow-up assessment.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01972724
|Korea, Republic of|
|Chagwon, Korea, Republic of|
|Daegu, Korea, Republic of|
|Daejeon, Korea, Republic of|
|Gwangju, Korea, Republic of|
|Gyeonggi-do, Korea, Republic of|
|Jeonju, Korea, Republic of|
|Seoul, Korea, Republic of|
|Ulsan, Korea, Republic of|
|Wonju, Korea, Republic of|
|Study Director:||Medical Director||Takeda|