Vascular Benefits of Adding CarvedilolCR to Type2 Diabetic Patients on ACEI.

NCT00430040 | Terminated Phase 4 Results

• 1 other identifier: 1918
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

To determine whether addition of Carvedilol CR to diabetic patients with hypertension who are receiving the ACEi,Lisinopril,will provide added benefits to blood vessels when compared to treatment with Lisinopril alone.It is believed that carvedilol provides added benefits by suppressing free radicals(charged substances that cause damage to the body ) and inflammation.

Conditions

Diabetes Mellitus, Type 2; Hypertension

Keywords

Type 2 Diabetes Mellitus; Hypertension; Carvedilol CR; Beta-blocker; Oxidative stress; Inflammation; Vascular benefits

Outcome Measures

Primary Outcomes (1)

• Change in Brachial Artery Vascular Reactivity

  Percent change from baseline in Brachial artery vascular reactivity at 6 months calculated as: (brachial reactivity at 6 months-brachial reactivity at 0 months)/brachial reactivity at 0 month \*100

  6 months

Secondary Outcomes (1)

• Change in Oxidative Stress in Mononuclear Cells (MNC)

  6 months

Study Arms (2)

carvedilol

EXPERIMENTAL

carvedilol

Drug: Carvedilol Controlled Release (CR); Drug: lisinopril

lisinopril

ACTIVE COMPARATOR

lisinopril

Drug: lisinopril

Interventions

Carvedilol Controlled Release (CR) DRUG

lisinopril starting dose in all patients 10 mg QD for 1 week then increase to 20 mg QD throughout the study. Initial dose: Carvedilol CR (20 mg QD, dose level 1) Titration: If tolerated, increase the dosage to 20 mg QD, 40 mg QD, and 80mg QD orally over successive intervals of at least 2 weeks to achieve target blood pressure sSBP \<130 and sDBP \< 80

Also known as: COREG CR

carvedilol

lisinopril DRUG

lisinopril starting dose in all patients 10 mg QD for 1 week then increase to 20 mg QD throughout the study

Also known as: lisinopril 10mg

carvedilol; lisinopril

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Is male or female \>= 18 and \<= 70 years of age
• Has a documented history of type 2 diabetes mellitus for a minimum of four months prior to the screening visit
• Has a documented history of or current presentation with Stage 1 or Stage 2 hypertension and meets one of the following criteria:
• Has controlled hypertension (sSBP \<130 mmHg AND sDBP \<80 mmHg) on \>=2 antihypertensive medications NOTE: A combination drug containing two antihypertensive agents represents two antihypertensive medications OR
• Has uncontrolled hypertension (sSBP \>=130 and \<=170 mmHg AND/OR sDBP \>=80 and \<=105 mmHg) on one or two antihypertensive medications OR
• Has newly diagnosed or previously untreated hypertension (sSBP \>=130 and \<=170 mmHg AND/OR sDBP \>=80 and \<=105 mmHg
• At Randomization, sitting systolic blood pressure (sSBP) \>= 130 mmHg or sitting diastolic blood pressure (sDBP) \>= 80 mmHg and sSBP \<= 170 mmHg and sDBP \<= 105 mmHg
• Has been on a stable dose of a 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor (statin) for a minimum of four months prior to the screening visit

You may not qualify if:

• Has any clinically significant abnormality identified in the screening physical examination, laboratory tests or electrocardiogram which, in the judgement of the investigator, would preclude safe completion of the study
• Is female of childbearing potential
• Has any of these cardiac conditions: uncontrollable or symptomatic arrhythmias, unstable angina, sick sinus syndrome or second or third degree heart block (unless treated with a permanent, functioning pacemaker), bradycardia (heart rate \<55 bpm), and stroke within three months of study screening, and history of myocardial infarction.
• Has Congestive Heart Failure NYHA (New York Heart Association) class II-IV
• Has type 1 diabetes mellitus
• Has newly diagnosed type 2 diabetes (within 4 months of screening visit)
• Has HbA1c \> 8.5%
• Has the following, as it relates to subject's antidiabetic therapy:Initiated or changed dosage or formulation of thiazolidinediones (TZDs) within 6 months of screening visit.
• A history of acute or chronic acidosis, including diabetic ketoacidosis
• Has current clinical diagnosis of chronic obstructive pulmonary disease (COPD, e.g., chronic bronchitis) or asthma
• Has a history of bronchospastic disease not undergoing active therapy in whom, in the investigator's opinion, treatment with study medication could provoke bronchospasm
• Has evidence of any of the following clinically significant diseases that could impair the absorption, metabolism, or excretion of orally-administered medication:
• renal disease defined as estimated Glomerular Filtration Rate (eGFR) \<60mL/min per 1.73 m2 using the Modification of Diet in Renal Disease (MDRD) formula below: GFR (mL/min/1.73m2) = 186 x \[Serum Creatinine (umol/L) x 0.0113\]-1.154 x Age(years)-0.203 (x 0.742 if female)
• hepatic disease (i.e., ALT or AST levels greater than three times the upper limit of normal range, history of hepatic impairment, or by clinical assessment)
• Chronic biliary disorders

Sponsors & Collaborators

• University at Buffalo: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

Diabetes - Endocrinology Center of Western New York

Buffalo, New York, 14221, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Hypertension; Inflammation

Interventions

Carvedilol; Lisinopril

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 3-Ring; Dipeptides; Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Paresh Dandona
• Organization: State University of NY at Buffalo

dandona@buffalo.edu

7165351852

Study Officials

• Paresh Dandona, MD, PhD

  Kaleida Health / University at Buffalo

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 30, 2007
• First Posted: February 1, 2007
• Study Start: February 1, 2007
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: April 16, 2024
• Results First Posted: April 16, 2024

Record last verified: 2024-03

Locations

US (1)