Assess the Effect of Bisoprolol on Glycemic Level in Type II Diabetic Patients With Suboptimal Blood Pressure Control (GIANT Study)

• Glycemic control measured by differences in the change from baseline HbA1C [ Time Frame: From baseline to 24 weeks ] [ Designated as safety issue: No ]
  

• Mean blood pressure calculated by 2 consecutive measurements with 2 minute intervals in sitting position after having seated quietly for at least 10 minutes [ Time Frame: From baseline to 24 weeks ] [ Designated as safety issue: No ]
  
• Insulin sensitivity as determined by HOMA-IR (Homeostasis model assessment-insulin resistance) [ Time Frame: From baseline to 24 weeks ] [ Designated as safety issue: No ]
  
• Lipid metabolism as determined by lipid profile (total cholesterol, LDL, HDL, TC) [ Time Frame: From baseline to 24 weeks ] [ Designated as safety issue: No ]
  
• Safety assessments includes adverse experiences, physical examination, vital signs and laboratory safety studies [ Time Frame: From baseline to 24 weeks ] [ Designated as safety issue: Yes ]
  
• Production ability of insulin in pancreas as determined by c-peptide and insulin [ Time Frame: From baseline to 24 weeks ] [ Designated as safety issue: Yes ]
  
• Microalbuminuria as determined by albumin/creatinine ratio [ Time Frame: From baseline to 24 weeks ] [ Designated as safety issue: Yes ]
  

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 β-blocker might have adverse effects in subjects with diabetes on glucose metabolism, but some data shows that highly β-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 Type II DM patient with suboptimal BP control.

After prescreening period, each enrolled subject with type II DM and suboptimal BP control will underwent 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 <130/80 mmHg during the first 2 month of treatment. The maximum dosage of bisoprolol will be 10 mg o.d. Following 6 month of added bisoprolol therapy, all efficacy and safety measurement will be repeated.

The duration of study will be up to 24 weeks for each patient.

OBJECTIVES

Primary objective:

• To assess the effect of bisoprolol on glycemic control measured by differences in the change from baseline HbA1C in Type II DM subjects with suboptimal BP control

Secondary objectives:

• To evaluate the effect of bisoprolol as add-on therapy, on blood pressure in Type II DM subjects with suboptimal BP control
• To evaluate the effect of bisoprolol as add-on therapy, on insulin sensitivity as determined by Homeostasis Model Assessment-Insulin Resistance (HOMA-IR)
• To evaluate the effect of bisoprolol as add-on therapy, on lipid metabolism as determined by lipid profile in Type II DM subjects with suboptimal BP control
• To evaluate the safety and tolerability of bisoprolol in Type II DM subjects with suboptimal BP control
• To assess the effect of bisoprolol combination therapy on insulin and c-peptide in type II diabetic patients with suboptimal blood pressure control compared to baseline
• To assess the effect of bisoprolol combination therapy on microalbumin and albumin/creatinine ratio in type II diabetic patients with suboptimal blood pressure control compared to baseline.