Conditions: Hypertension Diabetes
Keywords: Drug Therapy Hypertension and Diabetes
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 105
Healthy volunteers: no

Brief summary:
The purpose of this study was to evaluate the antihypertensive and antiglycemic effects, as well as the safety and tolerability of TAK-491 (azilsartan medoxomil), once daily (QD), in stage 1 hypertensive, type 2 diabetes mellitus (T2DM) participants whose glycemic control was inadequate on metformin alone.

Detailed description:
The study included a Screening Period of up to 4 weeks, which coincided with a 2-week single-blind, placebo Run-in Period, a 24 week Treatment Period, and a 2-week Follow-up Period. The duration of the study was approximately 30 weeks. The planned number of participants (n=450) was not reached; actual enrollment consisted of 105 particpants. Due to low enrollment this study was terminated early by Takeda.

Arms:
arm 1: Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 24 weeks. arm 2: Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 24 weeks. arm 3: Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 24 weeks.

Interventions: intervention 1: Placebo intervention 2: Azilsartan medoxomil intervention 3: Azilsartan medoxomil
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol document: