18 Week Study Evaluating Safety and Efficacy of Olmesartan, Amlodipine, and Hydrochlorothiazide, in Type 2 Diabetics

Daiichi Sankyo

Status and phase

Completed

Phase 4

Conditions

Hypertension

Type 2 Diabetes

Treatments

Drug: amlodipine / olmesartan medoxomil combination

Drug: Amlodipine

Drug: Hydrochlorothiazide

Study type

Interventional

Funder types

Industry

Identifiers

NCT00654745

CS-8663-403

Details and patient eligibility

About

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.

Full description

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.

Enrollment

207 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.