Phase 4 Study to Assess the Effect of Bisoprolol on Glycemic Level in Type II Diabetic Subjects With Suboptimal Blood Pressure Control
Condition: Hypertension; Diabetes Mellitus, Type II
MeSH terms: Hypertension; Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Bisoprolol
Intervention description: Bisoprolol tablet will be administered orally at dose of 5 milligram (mg) once daily for 24 weeks. If the blood pressure is not less than 130/80 millimeter of mercury (mmHg) during the first 8 weeks of treatment (up-titration), then the dose will be adjusted to 10 mg daily. In cases of hypotensive effect, symptomatic bradycardia or arrhythmia, the daily dose will be reduced to 2.5 mg.
Intervention MeSH terms: Bisoprolol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 202.0
Sex: All
Minimum age: 20 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Bisoprolol; Hypertension; Diabetes mellitus, Type II; Blood pressure; Glycemic level

Summary:

      This is a 24-week, prospective, multicenter, open-label, single-arm study to assess the
      effect of bisoprolol on glycemic level in Type 2 diabetes mellitus (T2DM) controlled subjects
      with hypertension. The hypothesis of study is that there is no change in glycemic level and
      lipid metabolism as determined by glycosylated hemoglobin (HbA1c) using bisoprolol in T2DM
      subjects with suboptimal blood pressure (BP) control.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age of 20 years or older and less than 80 years

          -  Subjects with T2DM

          -  Subjects who have failed to achieve an appropriate BP level as a result of treatment
             with any antihypertensive drug other than beta blockers - that is, with BP
             inadequately controlled to greater than or equal to (>=) 130/80 mmHg. However, those
             who have used a beta blocker before 12 weeks can be enrolled

          -  Subjects who underwent stable anti-diabetic regimen during the 12 weeks prior to
             screening

          -  Signed written informed consent

        Exclusion Criteria:

          -  Ongoing insulin therapy

          -  Change in two HbA1c levels measured at an interval of 4 weeks or longer for the
             previous 6 months is at least 1% (the last HbA1c is measured within 4 weeks)

          -  Secondary hypertension

          -  Subjects with renal impairment (creatinine greater than 150 micromol per liter or 1.7
             milligram per deciliter)

          -  Cardiovascular disease (uncontrolled or symptomatic arrhythmia, unstable angina, sick
             sinus syndrome, second or third degree atrioventricular (AV) block, bradycardia [less
             than 50 beats per minute], congestive heart failure, myocardial infarction, cerebral
             infraction attached within 12 weeks)

          -  Subjects requiring BP control by at least 3 different antihypertensive drugs, or with
             either systolic blood pressure (SBP) >=180 mmHg or diastolic blood pressure (DBP)
             >=110 mmHg at baseline

          -  Subjects with type 1 diabetes mellitus (T1DM)

          -  Uncontrolled diabetes with HbA1c >9%

          -  BMI >40 kilogram per square meter (kg/m^2)

          -  Pulmonary disease (chronic obstructive pulmonary disease [COPD], bronchial asthma)

          -  Other patients considered by the investigator to be not eligible for participation in
             this study for a legal or mental reason

          -  Contraindications for beta-blocker

          -  Pregnant or lactating women

          -  Use of an investigational drug within 30 days of entry to the study