Conditions: Type II Diabetes Mellitus
Keywords: Drug therapy
Allocation: RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 114
Healthy volunteers: no

Brief summary:
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.

Detailed description:
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.

Arms:
arm 1: Pioglitazone 15 mg tablets, orally, once daily, and metformin and sulfonylurea administered according to the prescribing information of the approved Korean label, for up to 24 weeks. arm 2: Pioglitazone 30 mg tablets, orally, once daily, and metformin and sulfonylurea administered according to the prescribing information of the approved Korean label, for up to 24 weeks. arm 3: Pioglitazone 30 mg tablets, orally, once daily, and metformin and sulfonylurea administered according to the prescribing information of the approved Korean label, for up to 24 weeks.

Interventions: intervention 1: Pioglitazone intervention 2: Metformin intervention 3: Sulfonylurea
Intervention descriptions: intervention 1: Pioglitazone tablets intervention 2: Metformin as prescribed in clinical practice intervention 3: Sulfonylurea as prescribed in clinical practice

Protocol document: