Conditions: Type 2 Diabetes Mellitus
Keywords: diabetes mellitus
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 299
Healthy volunteers: no

Brief summary:
This study is intended to assess the effect on HbA1c of different dose regimens of LX4211 in combination with metformin in subjects with Type 2 Diabetes Mellitus who have inadequate glycemic control on metformin monotherapy.

Detailed description:

Arms:
arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None

Interventions: intervention 1: 75 mg LX4211 intervention 2: 200 mg LX4211 intervention 3: 400 mg LX4211 intervention 4: 200 mg LX4211 intervention 5: Placebo
Intervention descriptions: intervention 1: Subjects will receive 75 mg LX4211 once daily intervention 2: Subjects will receive 200 mg LX4211 once daily. intervention 3: Subjects will receive 400 mg LX4211 once daily. intervention 4: Subjects will receive 200 mg LX4211 twice daily. intervention 5: Subjects will receive placebo once daily.

Protocol document: