Efficacy and Safety of Azilsartan Medoxomil Used in Combination With Metformin in Participants With Hypertension and Diabetes

The study includes a Screening Period of up to 4 weeks, which coincides 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 will be approximately 30 weeks.

Inclusion Criteria:

1. The participant is male or female and ≥18 years.

2. The participant has type 2 diabetes mellitus with HbA1c of ≥7.5 to ≤9.5% at
Screening.

3. Participant is currently treated with metformin alone (no treatment with any
antidiabetic agents other than metformin within the 3 months prior to Screening) and
is experiencing inadequate glycemic control. The participant should have received
metformin monotherapy for ≥8 weeks prior to Screening at a stable dose ≥1500 mg).
Participants with a maximum tolerated dose (MTD) that is documented to be less than
1500 mg of metformin may also be enrolled if this dose has been stable for 8 weeks
prior to Screening.

4. The participant is treated with antihypertensive therapy and has a mean, trough,
sitting clinic systolic blood pressure (SBP) ≥135 and < 160 mm Hg on Day -1 (after
washout of prior antihypertensive therapy) or the participant has not received
antihypertensive treatment within 28 days before Screening and has a mean sitting
clinic SBP ≥135 and < 160 mm Hg at the Screening Visit and on Day -1.

5. The participant has clinical laboratory evaluations (including clinical chemistry,
hematology, and complete urinalysis) within the reference range for the testing
laboratory or results that are deemed not clinically significant in this participant
population for inclusion into this study by the investigator.

Exclusion Criteria:

1. The participant has a mean, trough, sitting clinic diastolic blood pressure (DBP)
≥100 mm Hg at Day -1.

2. The participant has type 1 or poorly controlled type 2 diabetes mellitus (HbA1c
>9.5%) at Screening.

3. The participant is taking or expected to take an excluded medication.

4. The participant has a history of myocardial infarction, heart failure, unstable
angina, coronary artery bypass graft, percutaneous coronary intervention,
hypertensive encephalopathy, cerebrovascular accident, or transient ischemic attack.

5. The participant has clinically significant cardiac conduction defects (for example,
3rd degree atrioventricular block, left bundle branch block, sick sinus syndrome,
atrial fibrillation).

6. The participant has hemodynamically significant left ventricular outflow obstruction
due to aortic valvular disease.

7. The participant has secondary hypertension of any etiology (e.g., renovascular
disease, pheochromocytoma, Cushing's syndrome).

8. The participant has renal dysfunction defined as estimated glomerular filtration rate
(eGFR) <60 mL/min/1.73 m2 at Screening.

9. The participant has albuminuria defined as >200 mg/g at Screening.

10. The participant has known or suspected unilateral or bilateral renal artery stenosis.

11. The participant has unexplained microhematuria ≥3 RBCs/HPG or macrohematuria at
Screening and confirmed on repeat testing.

12. Treatment with antidiabetic agents (sulfonylureas, glucagon-like peptide-1 (GLP-1)
analogues, dipeptidyl peptidase-4 (DPP-4) inhibitors, glinides, thiazolidinediones
(TZDs), and/or insulin) other than metformin during the 3 months prior to Screening.

13. The participant has hyperkalemia as defined by central laboratory normal reference
range at Screening.