Long-term Safety Study of Alogliptin Used in Combination With Sulfonylurea or Metformin in Participants With Type 2 Diabetes in Japan

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

576

Participants

Timeline

Start Date

January 31, 2009

Primary Completion Date

January 31, 2010

Study Completion Date

April 30, 2010

Conditions
Type 2 Diabetes Mellitus
Interventions
DRUG

Alogliptin and glimepiride

Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.

DRUG

Alogliptin and glimepiride

Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.

DRUG

Alogliptin and metformin

Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.

DRUG

Alogliptin and metformin

Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Takeda

INDUSTRY