Controlled, Randomized, Double-Blind, Phase ? Clinical Trial to Evaluate Metabolic Effects of Carvedilol and Atenolol in Hypertension with Type ? Diabetes Mellitus

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0000974

Enrollment

176

Registered

2014-01-06

Start date

2012-02-14

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : Experimental group: Carvedilol 12.5mg/25mg Control group: Atenolol 25mg/50mg Duration of treatment: 24weeks Starting dose: 12.5mg in carvedilol and 25mg in atenolol respectively Dose escalati

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) aged 30-80 years 2) Patients who have type 2 diabetes and hypertension(SBP=140mmHg ?? DBP=90mmHg) concurrently 3)Patients who use following antihypertensive drug with mono or combination therapy without change in drug dosage within 1 month before enrollment drug: Angiotensin-converting enzyme(ACE) Inhibitor, Angiotension II receptor blocker(ARB, Calcium channel blocker(CCB) 4). Diabetic patients who use oral anti-diabetic drug without any change in drug dosage within 3 month before enrollment

Exclusion criteria

Exclusion criteria: 1)uncontrolled arrythmia 2)unstable angina 3)sick sinus syndrome. 2nd or 3rd AV block 4)Congestive heart failure or patients under treatment of heart failure 5)Acute MI or cerebral infarction in the 3 month prior to screening 6)Bradycardia (HR 8.5% -Serum Creatinine > 2.5 mg/dl -AST/ALT > 2.5x ULN -Total Bilirubin > 2.5 xULN -Alkaline phosphatase > 2.5 x ULN 11)pheochromocytoma, hyperthyroidism, thyrotoxicosis 12)Benign prostate hyperplasia, erectal dysfunction 13)Use of insulin 14)type 1 DM, diabetes ketoacidosis 15)Use of ß-blockers within 3 months prior to screening 16)Cardiogenic shock 17)severe peripheral arterial disease 18)Patients who need consistent steroid treatment 19)allergy to carvedilol or atenolol 20)malignancy 21) pregnany, potential pregnancy, lactating or woman unwilling to take reliable contraceptive measures during the study 22) History of thyrotoxicosis related to drug 23)Participation in another clinical study, either currently or within 4 weeks prior to providing informed consent

Design outcomes

Primary

Measure	Time frame
change from baseline in HbA1c	—

Secondary

Measure	Time frame
chage from baseline in Fasting blood glucose;chage from baseline in BP ;chage from baseline in insulin. ;chage from baseline in insulin resistance ;chage from baseline in lipid;chage from baseline in Albumin/creatinin ratio;chage from baseline in Anthropometric measurements	—

Countries

Korea, Republic of

Contacts

Public ContactJicheol Bae

Samsung Medical Center

Outcome results