Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Daiichi Sankyo
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.
Age
18–80
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
Clareo Health | 18 Week Study Evaluating Safety and Efficacy of Olmesartan, Amlodipine, and Hydrochlorothiazide, in Type 2 Diabetics
