18 Week Study Evaluating Safety and Efficacy of Olmesartan, Amlodipine, and Hydrochlorothiazide, in Type 2 Diabetics
18 Week Study Evaluating Safety and Efficacy of Olmesartan, Amlodipine, and Hydrochlorothiazide, in Type 2 Diabetics
To determine if olmesartan plus amlodipine combination therapy alone and with
 hydrochlorothiazide will be safe and effective to reduce high blood pressure in hypertensive,
 type 2 diabetic subjects.
This is a single group study in which participants were titrated to the next of 6 regimens if
 blood pressure (BP) goals were not met.
Inclusion Criteria:

 -  Males or females aged 18 to 80 years.

 -  Diagnosis of type 2 diabetes mellitus and on a stable regimen of any oral antidiabetic
 agent(s) for at least 3 months, with or without adjunctive use of Byetta (exenatide);

 Note: Subjects diagnosed with type 2 diabetes mellitus who were not on oral antidiabetic
 agents may have been enrolled if they had a documented history of type 2 diabetes by
 American Diabetes Association criteria, including the specific plasma glucose results
 listed below:

 -  Fasting plasma glucose >=126 mg/dL (7.0 mmol/L); or

 -  Symptoms of hyperglycemia and a casual (any time of day without regard to time since
 last meal) plasma glucose >=200 mg/dL (11.1 mmol/L). The classic symptoms of
 hyperglycemia were considered to include polyuria, polydipsia, and unexplained weight
 loss; or

 -  Two-hour plasma glucose >=200 mg/dL (11.1 mmol/L) during an oral glucose tolerance
 test;

 -  Newly diagnosed hypertension or uncontrolled hypertension (defined as SBP >130 mmHg
 and/or DBP >80 mmHg) on current antihypertensive monotherapy or combination therapy.

 -  Subjects must fulfill mean seated office blood pressure parameters at two consecutive,
 qualifying visits during the placebo run-in phase, and, subsequently, daytime
 ambulatory blood pressure monitoring (ABPM) criteria.

 -  Females should not be pregnant or lactating and, if applicable, using adequate
 contraception.

 Exclusion Criteria:

 -  Subjects with uncontrolled hypertension taking multiple antihypertensive therapies (at
 the discretion of the investigator).

 -  Type 2 diabetes mellitus with a glycosylated hemoglobin A1c (HbA1c) >=9.0% at
 screening;

 -  Subjects with type 1 or type 2 diabetes mellitus requiring insulin.

 -  Subjects with any serious disorder which may limit the ability to evaluate the safety
 and efficacy of study medication, or subjects with secondary hypertension.