Diabetes Mellitus, Type 2Phase 4NCT00430040
Vascular Benefits of Adding CarvedilolCR to Type2 Diabetic Patients on ACEI.
A Phase 4 study testing lisinopril in people with Diabetes Mellitus, Type 2 and Hypertension, run by University at Buffalo at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, Hypertension
- What is being tested?
- lisinopril
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2007to May 2013
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 20Show fewer
- 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
- Has endocrine disorders (e.g., pheochromocytoma, active and untreated hypo or hyperthyroidism)
- Has any known contraindication to ACE inhibitors, alpha- or beta-blocker treatment
- Has systemic disease, including cancer, with reduced (<12 months) life expectancy
- Has used an investigational drug within 30 days or 5 half-lives (whichever is longer) preceding the first dose of study medication
- Has a history of a psychological illness or any condition that would interfere with the subject's ability to understand or complete the requirements of the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Diabetes - Endocrinology Center of Western New York
Buffalo, New York, 14221
About this study
Official title: Vascular Benefits of Adding CarvedilolCR to Type2 Diabetic Patients on ACEI:Effects on Oxidative Stress and Inflammation.
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.
Read the detailed description
Type 2 diabetes is an atherosclerotic, pro-inflammatory and pro-oxidative stress.Both vascular oxidative stress and inflammation are CVD risk factors and impact endothelial function.
Carvedilol has been demonstrated in preclinical and clinical studies (although limited in size) to exert anti-inflammatory and antioxidant properties: (1) reduce the inflammation markers such as high sensitivity C-reactive protein (hsCRP); (2) reduce oxidative stress via dually eliminating existing reactive oxygen species (ROS) and suppressing the generation of ROS; (3) prevent lipid peroxidation in myocardial cell membrane; (4) protect endothelial and vascular muscle cells from oxygen radical-mediated injury.
This project is about studying the effect of carvedilol CR on blood vessels of diabetic hypertensive patients as compared to Lisinopril alone.
This study involves weaning patient off their current antihypertensive medications and starting them on Lisinopril with Carvedilol CR or lisinopril alone for 6 months and studying the effects of the drugs during this period and thereafter.
- Conditions
- Diabetes Mellitus, Type 2, Hypertension
- Being tested
- Carvedilol Controlled Release (CR), lisinopril
- Keywords
- Type 2 Diabetes Mellitus, Hypertension, Carvedilol CR, Beta-blocker, Oxidative stress, Inflammation, Vascular benefits
- Medical subject headings
- Diabetes Mellitus, Type 2, Hypertension, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carvedilol Controlled Release (CR)Drug
Also called COREG CR
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
lisinoprilDrug
Also called lisinopril 10mg
lisinopril starting dose in all patients 10 mg QD for 1 week then increase to 20 mg QD throughout the study
| Study group | Role | What they receive |
|---|---|---|
| carvedilol | Experimental | carvedilol Receives: Drug: Carvedilol Controlled Release (CR); Drug: lisinopril |
| lisinopril | Active comparator | lisinopril Receives: Drug: lisinopril |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Secondary outcomes (1)
Change in Oxidative Stress in Mononuclear Cells (MNC)
Percent change from baseline in Reactive Oxygen species (ROS) generation in MNC at 6 months calculated as: (ROS at 6 months-ROS at 0 months)/ROS at 0 month *100
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2007 (estimated)
- Study startFeb 2007
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University at Buffalo
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Principal investigator, Paresh Dandona, University at Buffalo
- Investigators
- Paresh Dandona, MD, PhD, Principal investigator, Kaleida Health / University at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00430040
- Sponsor's protocol ID
- 1918
- Status last verified
- Mar 2024
- First submitted
- 30 Jan 2007
- Last updated
- 16 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vascular Benefits of Adding CarvedilolCR to Type2 Diabetic Patients on ACEI:Effects on Oxidative Stress and Inflammation.
- ClinicalTrials.gov ID
- NCT00430040
- Acronym / sponsor ID
- 1918
- Conditions
- Diabetes Mellitus, Type 2, Hypertension
- Keywords
- Type 2 Diabetes Mellitus, Hypertension, Carvedilol CR, Beta-blocker, Oxidative stress, Inflammation, Vascular benefits
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University at BuffaloUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- Feb 2007 (actual)
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 1 Feb 2007 (estimated)
- Results
- Posted 16 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Type 2 diabetes is an atherosclerotic, pro-inflammatory and pro-oxidative stress.Both vascular oxidative stress and inflammation are CVD risk factors and impact endothelial function.
Carvedilol has been demonstrated in preclinical and clinical studies (although limited in size) to exert anti-inflammatory and antioxidant properties: (1) reduce the inflammation markers such as high sensitivity C-reactive protein (hsCRP); (2) reduce oxidative stress via dually eliminating existing reactive oxygen species (ROS) and suppressing the generation of ROS; (3) prevent lipid peroxidation in myocardial cell membrane; (4) protect endothelial and vascular muscle cells from oxygen radical-mediated injury.
This project is about studying the effect of carvedilol CR on blood vessels of diabetic hypertensive patients as compared to Lisinopril alone.
This study involves weaning patient off their current antihypertensive medications and starting them on Lisinopril with Carvedilol CR or lisinopril alone for 6 months and studying the effects of the drugs during this period and thereafter.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| carvedilol | Experimental | Drug: Carvedilol Controlled Release (CR), Drug: lisinoprilcarvedilol |
| lisinopril | Active comparator | Drug: lisinoprillisinopril |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Carvedilol Controlled Release (CR)Also: COREG CRlisinopril 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 | Drug | carvedilol |
| lisinoprilAlso: lisinopril 10mglisinopril starting dose in all patients 10 mg QD for 1 week then increase to 20 mg QD throughout the study | Drug | carvedilol, lisinopril |
Primary outcome
Change in Brachial Artery Vascular Reactivity
Time frame: 6 months
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
1 secondary outcome
Change in Oxidative Stress in Mononuclear Cells (MNC)
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paresh Dandona, MD, PhD principal investigator
Kaleida Health / University at Buffalo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing lisinopril in people with Diabetes Mellitus, Type 2 and Hypertension, run by University at Buffalo at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Brachial Artery Vascular Reactivity (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2024.