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
Study type: Interventional
Phase: Phase 4

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.
    

Detailed description: 
      Diabetes mellitus and hypertension are two of the most common chronic conditions, and each
      predisposes to accelerated atherosclerosis, cardiovascular disease, and death. There has been
      a concern that beta-blocker might have adverse effects in subjects with diabetes on glucose
      metabolism, but some data shows that highly beta-1 selective agents such as bisoprolol are
      essentially free of metabolic disturbances involving blood sugar, insulin sensitivity and
      lipids.

      This is a prospective, multicenter, single-arm, open-label study to assess the glycemic
      effect of bisoprolol in T2DM subjects with suboptimal BP control.

      After pre-screening period, each enrolled subject with T2DM and suboptimal BP control will
      undergo laboratory test for efficacy and safety measurement. After that, subject will
      continue his/her usual dosage of antihypertensive medication and bisoprolol will be added.

      Subjects will be instructed to continue their diet and level of physical activity and to
      attempt to maintain current body weight until completion of the study.

      Bisoprolol will be titrated upward until a dosage that lowers BP to less than 130/80
      millimeter of mercury (mmHg) during the first 2 months of treatment. The maximum dosage of
      bisoprolol will be 10 mg once daily. Following 6 month of added bisoprolol therapy, all
      efficacy and safety measurements will be repeated.

      The duration of study will be up to 24 weeks for each subject.

      Objectives

      Primary objective:

        -  To assess the effect of bisoprolol on glycemic control measured by change from baseline
           in HbA1c in T2DM subjects with suboptimal BP control

      Secondary objectives:

        -  To evaluate the effects of bisoprolol, as add-on therapy, on BP in T2DM subjects with
           suboptimal BP control

        -  To evaluate the effects of bisoprolol, as add-on therapy, on insulin sensitivity as
           determined by Homeostasis Model Assessment-Insulin Resistance (HOMA-IR)

        -  To evaluate the effects of bisoprolol, as add-on therapy, on lipid metabolism as
           determined by lipid profile in T2DM subjects with suboptimal BP control

        -  To evaluate the safety and tolerability of bisoprolol in T2DM subjects with suboptimal
           BP control

        -  To assess the effects of bisoprolol combination therapy on insulin and c-peptide in T2DM
           subjects with suboptimal BP control compared to baseline

        -  To assess the effects of bisoprolol combination therapy on microalbumin and
           albumin/creatinine ratio in T2DM subjects with suboptimal BP control compared to
           baseline
    

Intervention name(s): Bisoprolol
Intervention type(s): Drug
Intervention description(s): 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.
Other intervention name(s): Concor; Concor Plus; ConcorCor; Lodoz
Intervention MeSH terms: Bisoprolol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bisoprolol; Hypertension; Diabetes mellitus, Type II; Blood pressure; Glycemic level