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LCZ 696 for Type 2 Diabetes
Study Summary
This trial will help researchers learn more about how diabetes affects heart function and whether a new treatment can prevent heart failure in people with diabetes.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- Your HbA1C level is higher than 9% when you join the study.Your blood sodium levels are very low (< 125 mEq/dL) or very high (> 160 mEq/dL).You are allergic to iodine.I have type 2 diabetes.I do not have severe heart valve issues, thickened heart muscles, or specific heart inflammations.You have experienced a specific type of heart rhythm problem within the last 14 days.I do not have any health conditions that could make this study unsafe for me.I can walk more than 450 meters in 6 minutes, or less if due to hip/knee pain.I was born with a serious heart condition.I have not had a stroke or significant brain blood flow issues in the last 3 months.Your hemoglobin level is less than 9 grams per deciliter.You have a specific type of heart block without a pacemaker.I am currently on water pills for my heart or kidneys.I have not had a heart attack in the last 6 months.My kidney function is severely reduced.Your ALT levels are more than two times the normal limit.Your blood potassium levels are too low or too high.My heart pumps well and I've never had heart failure.I have been on diabetes medication for at least 6 months.I have not had unstable chest pain in the last 6 months.I am currently pregnant or breastfeeding.I have been diagnosed with or shown signs of heart failure.
- Group 1: LCZ 696
- Group 2: Placebos
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Can older people participate in this research?
"This study is open to participants aged 18-85."
Do people exhibit negative side effects from LCZ 696?
"LCZ 696's safety is based off of preclinical data and was given a score of 2."
Which type of person is this research looking for?
"This clinical study is looking for 72 males and females, aged 18 to 85, that have type 2 diabetes mellitus. In addition to this broad inclusion criteria, participants must also meet the following specific conditions: EF > 50% without diastolic dysfunction or EF > 50% with grade 2 or more diastolic dysfunction, without prior diagnosis, or signs and symptoms, of heart failure, 60 male and female subjects >18years of age, Type 2 diabetes mellitus, On at least one oral hypoglycemic agent, or glucagon-like peptide analogue or insulin, for at least 6 months, Minimal distance of >450"
Are participants currently being recruited for this research?
"No, this particular clinical trial is not presently recruiting patients. However, according to the data hosted on clinicaltrials.gov, it was last edited on 8/18/2022. There are many other clinical trials (874 in total) that are actively looking for patients right now."
How many people are included in the experimental group for this clinical trial?
"This study has completed recruitment for participants. However, if you're looking for other research opportunities, 835 clinical trials are currently underway that focus on diabetes mellitus, type 2 and 39 studies are investigating the efficacy of LCZ 696."
Can you give us some background on other similar research projects to LCZ 696?
"There are currently 8 Phase 3 trials and 39 total studies being conducted for LCZ 696. The majority of these research sites are located in Montreal, but there are a grand total of 812 locations running clinical trials for LCZ 696."
What are LCZ 696's primary therapeutic benefits?
"Patients with uncontrolled hypertension and Ventricular Dysfunction can find relief with LCZ 696."
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