The purpose of this study is to evaluate the efficacy of pioglitazone 30 mg on glycemic control when used in participants with inadequately controlled type 2 diabetes mellitus treated with stable combinations of metformin and sulfonylurea.
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-center 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
114
Pioglitazone tablets
Metformin as prescribed in clinical practice
Sulfonylurea as prescribed in clinical practice
Unnamed facility
Chagwon, South Korea
Unnamed facility
Daegu, South Korea
Unnamed facility
Daejeon, South Korea
Unnamed facility
Gwangju, South Korea
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at 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. A negative change from baseline indicates improvement.
Time frame: Baseline and Week 24
Change From Baseline in Fasting Plasma Glucose at Week 24
The change between the value of fasting serum glucose collected at Week 24 and fasting serum glucose collected at baseline. A negative change from baseline indicates improvement.
Time frame: Baseline and Week 24
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Unnamed facility
Gyeonggi-do, South Korea
Unnamed facility
Jeonju, South Korea
Unnamed facility
Seoul, South Korea
Unnamed facility
Ulsan, South Korea
Unnamed facility
Wŏnju, South Korea