Clinical trial NCT01890122
Conditions: Diabetes Mellitus
Keywords: Drug therapy
Sponsor: Takeda
Start date: 2013-09-01; Completion date: 2015-10-01
Enrollment: 647 participants; Allocation: RANDOMIZED; Intervention model: FACTORIAL

Brief summary:
The purpose of this study is to evaluate the efficacy and safety of alogliptin and metformin fixed-dose combination (FDC) as compared with alogliptin alone or metformin alone on Type 2 Diabetes Mellitus (T2DM).

Detailed description:
The drug being tested in this study is a fixed-dose combination tablet of alogliptin and metformin to treat people who have diabetes. This study will look at glycemic control in people who take alogliptin and metformin FDC compared with alogliptin or metformin alone. The study will enroll approximately 640 patients. Participants will be randomly assigned (by chance, like flipping a coin) to one of the four treatment groups-which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need):

* Alogliptin 12.5 mg twice daily (BID)
* Metformin hydrochloride (HCl) 500 mg BID
* Alogliptin 12.5 mg and Metformin HCl 500 mg FDC BID
* Placebo (dummy inactive pill) - this is a tablet/capsule that looks like the study drug but has no active ingredient.

All participants will be asked to take 2 tablets and 1 capsule twice a day at the same time each day throughout the study. All participants will be asked to record any hypoglycemic events in a diary. This multi-center trial will be conducted in China, South Korea, Taiwan and Malaysia. The overall time to participate in this study is 34 weeks. Participants will make 11 visits to the clinic.

Arms: arm 1: Metformin hydrochloride (HCl) 500 mg, capsules, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; alogliptin and metformin HCl fixed dose combination (FDC) placebo-matching tablets, orally, twice a day for up to 26 weeks. arm 2: Alogliptin 12.5 mg, tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day; alogliptin and metformin HCl FDC placebo-matching tablets, orally, twice a day for up to 26 weeks. arm 3: Alogliptin 12.5 mg and metformin HCl 500 mg FDC, tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks. arm 4: Alogliptin and metformin FDC placebo-matching tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
Interventions: intervention 1: Alogliptin intervention 2: Metformin HCl intervention 3: Alogliptin and Metformin Fixed-Dose Combination (FDC) intervention 4: Alogliptin Placebo intervention 5: Metformin Placebo intervention 6: Alogliptin and Metformin FDC Placebo
Intervention descriptions: intervention 1: Alogliptin tablets intervention 2: Metformin HCl capsules intervention 3: Alogliptin and metformin FDC tablets intervention 4: Alogliptin placebo-matching tablets intervention 5: Metformin placebo-matching capsules intervention 6: Alogliptin and metformin FDC placebo-matching tablets

Protocol documents: