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

2014-08-27 03:16:01 | BioPortfolio

Summary

This is a 28-week, prospective, multicenter, open-label, single arm study to assess the effect of bisoprolol on glycemic level in Type II diabetes mellitus (DM) controlled subjects with hypertension. The hypothesis of study is that there is no change in glycemic level and lipid metabolism as determined by HbA1C using bisoprolol in Type II DM subjects with suboptimal blood pressure (BP) control.

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 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 20 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 28 weeks for each patient. This will include a 4-week screening and a 24-week treatment period.

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Hypertension

Intervention

Bisoprolol

Status

Not yet recruiting

Source

Merck KGaA

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:16:01-0400

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