MNCs have played a significant role in the clinical trials of metformin FDCs. Information provided by (Responsible Party): Participants in the PEP cohort of the trial are those who do not test positive for SARS-COV-2 infection at the time of screening but had a close exposure to SARS-CoV-2 infected person (defined by current CDC definition of close contact). Mechanisms of anti-cancer action This is a substudy with laboratory outcomes (70 patients will be enrolled). Dr. Metformin, a drug typically used for the treatment of diabetes, may help to reduce the growth of cancerous tumor cells in participants with malignant solid tumors. Clinical trials are an important step in our being able to have new treatments for diabetes and other conditions. Hospitalized, for COVID-19 or other reasons. The fully powered trial is a parallel enrolling treatment and post-exposure prophylaxis trial. Metformin, a biguanide derived from the French lilac, has become the preferred first-line therapy for the treatment of type 2 diabetes (1). The discovery of metformin began with the synthesis of galegine-like compounds derived from Gallega officinalis, a plant traditionally employed in Europe as a drug for diabetes treatment for centuries [].In 1950, Stern et al. Metformin was also effective at weight loss and reduction in blood pressure. Clinical trials look at new ways to prevent, detect, or treat disease. All trials on the list are supported by NCI. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Eight different companies were represented as sponsors in the trials, with nine studies sponsored by MNCs. Gordon et al found decreased SARS-CoV-2 and increased cell viability with metformin in vitro. NCI’s basic information about clinical trials explains the types and phases of trials and how they are carried out. Talk to your doctor for help in deciding if one is right for you. Scientist report that patients with Type 1 diabetes who become infected with the COVID19 may develop a diabetes complication known as ketoacidosis. The clinical trials on this list are studying Metformin Hydrochloride. The Contribution of Incretin Hormones to the Amelioration of Glucose Metabolism After Roux-en-Y Gastric Bypass Rochester, MN This is one of the primary outcomes for the stage 1 trial. The purpose of this study is to further advance the ability to practice personalized medicine by learning which new drug agents are most effective with which types of breast cancer tumors and by learning more about which early indicators of response (tumor analysis prior to surgery via magnetic resonance imaging (MRI) images along with tissue and blood samples) are predictors of treatment success. Giving metformin hydrochloride, cisplatin and external beam radiation therapy may work better at treating head and neck squamous cell cancer. Metformin suppresses colorectal aberrant crypt foci in a short-term clinical trial. Eighteen of the 25 published clinical trials conducted in patients with type 2 diabetes disclosed sponsor funding or were conducted by pharmaceutical companies. While vaccine development for SARS-CoV-2 has been promising, there may be reduced willingness among the public to receive a vaccine developed so quickly. Metformin hydrochloride may prevent or lower risk of breast cancer and decrease cancer cells, lower risk of cancer spreading. Positive laboratory test for active SARS-CoV-2 viral infection based on local laboratory standard (i.e. Participants in this arm and group will receive placebo. Metformin hydrochloride may reduce the metabolic activity of cancer cell and of surrounding supportive tissues. The fully powered trial is a parallel enrolling treatment and post-exposure prophylaxis trial.  (Clinical Trial). article SPHK1 Is a Novel Target of Metformin in Ovarian Cancer. Genetic and Rare Diseases Information Center. discovered the clinical usefulness of metformin while working in Paris. A study in 180 patients from across the United States with type 1 diabetes and COVID-19 included 43% […] Bramante et al. The DPP was a randomized, controlled clinical trial conducted at 27 clinical centers around the United States from 1996 to 2001. These studies provide important information to advance medical research and are crucial to developing a cure for diabetes. What clinical trials for diabetes are open? Participants in this arm and group will receive the metformin. Bramante et al, Lancet Healthy Longevity, females with DM or obesity, claims data from 50 US5 states: OR mortality 0.759 (0.601, 0.960) by propensity matching; OR 0.785 (0.650, 0.951) by Cox model. Drugs used in chemotherapy, such as carboplatin, paclitaxel and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Assessed with Symptom Scale Recommended by FDA for Industry 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities. What does the clinical trial consist of? Studying samples of blood and tissue in the laboratory from patients receiving metformin hydrochloride may help doctors learn more about the effects of metformin hydrochloride on cells. Talk with your doctor and family members or friends about deciding to join a study. Type 1 diabetes —includes studies funded by the NIH or other U.S. Government agencies For general information, Learn About Clinical Studies. ClinicalTrials.gov Identifier: NCT04510194, Interventional It is not yet known whether giving metformin hydrochloride together with doxycycline may be a better way in treating patients with localized breast, uterine, or cervical cancer. Before joining a clinical trial, it’s important to ask questions and get a sense of what will be required in the clinical trial. Location: 14 locations, This early phase I trial studies the effects of metformin hydrochloride in participants with malignant solid tumors. Outcome is reported as the change in serum concentrations of c-reactive protein (mg/L) from baseline to 5 days and baseline to 10 days. Studies show that metformin may influence metabolic and cellular processes that are associated with the development of age-related conditions. Since September 27, 2007, results of Lilly clinical trials have been presented on clinicaltrials.gov for compounds that are approved for use in humans. The GRADE Study is a pragmatic, unmasked clinical trial that will compare commonly used diabetes medications, when combined with metformin, on glycemia-lowering effectiveness and patient-centered outcomes. Outcome is reported as the change in serum concentrations of albumin (g/dL) from baseline to 5 days and baseline to 10 days. Participants in this arm and group will receive metformin. by Sean McBride, MD, PhD FRAXA Research Foundation is sponsoring a metformin pilot clinical trial to test the safety, tolerability and efficacy of treating cognition, sleep, attention and anxiety in teens and adults with Fragile X. Metformin is an FDA-approved compound with an established safety profile and minimal side effects. External beam radiation therapy uses high-energy beams to kill tumor cells and shrink tumors. In a 16-week randomised clinical trial involving 390 individuals with type 2 diabetes, compared with placebo, the addition of metformin to insulin therapy (basal/bolus regimens) resulted in superior glycaemic control, improved HbA 1c (6.9% [51.9 mmol/mol] vs 7.6% [59.6 mmol/mol], metformin+insulin vs placebo; both from baselines of approximately 7.9% [62.8 mmol/mol]; p < … If certain medical tests, such as an X-ray scan, for example, make you uncomfortable, ask in advance if those or other procedures will be part of the clinical trial. Researchers think that metformin may reduce the risk of getting prostate cancer or may even be able to treat it. All trials on the list are supported by NCI. Giving metformin, nelfinavir, and bortezomib may work better in treating patients with multiple myeloma. Six observational studies have found decreased severity of Covid-19 disease among persons with metformin use before diagnosis with Covid-19: Kow, J Med Virol conducted a meta analysis, with an overall odds ratio for mortality of 0.62 (0.43-0.89). Participants in the treatment arm of the trial are those who test positive for SARS-COV-2 infection at the time of screening. Participants in the treatment arm of the trial are those who test positive for SARS-COV-2 infection at the time of screening. Location: University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, This phase II pilot trial studies how will metformin hydrochloride works in mitigating the side effects of radioactive iodine treatment in patients with differentiated thyroid cancer. Urbana, Ill. (WCIA) Dr. Arnon Gal, veterinarian with the internal medicine service at the University of Illinois Veterinary Teaching Hospital, shares details on an exciting new clinical trial that is open to dogs and cats in our viewing area that have diabetes. The clinical trials on this list are studying Metformin Hydrochloride. Learn more about the study here: Pet owners with pets that meet study […] Location: 3 locations, This early phase I trial studies how well metformin hydrochloride works when added to levonorgestrel-releasing intrauterine system in treating patients with atypical endometrial hyperplasia or endometrial cancer who cannot undergo surgery. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. Location: 12 locations, This pilot phase II trial studies how well metformin hydrochloride works in treating patients with chronic lymphocytic leukemia that has come back or untreated chronic lymphocytic leukemia with genomic deletion 11q. Doxycycline may stop the growth of bacteria by keeping them from making proteins and minimized the toxic side effects of anti-cancer therapy. The Diabetes Prevention Program randomized clinical trial demonstrated that intensive lifestyle intervention and metformin therapy reduced progression to diabetes by 58 and 31%, respectively, compared to placebo in people at risk of type 2 diabetes. The TAME (Targeting Aging with Metformin) Trial will establish a clinical trial to provide proof-of-concept that aging can be treated, just as we treat diseases. Epub 2020 Apr 30. Test if metformin treatment in non-hospitalized adults with SARS-CoV-2 disease can prevent Covid-19 disease progression. Metformin hydrochloride may help carboplatin, paclitaxel and docetaxel work better by making tumor cells more sensitive to the drugs. The VA IMPACT trial is currently evaluating metformin versus placebo among patients without diabetes and is powered for cardiovascular outcomes. Giving metformin hydrochloride in addition to treatment with levonorgestrel-releasing intrauterine system may be an effective alternative for patients with atypical endometrial hyperplasia or endometrial cancer who cannot undergo surgery. A listing of Diabetes Mellitus Type 2 medical research trials actively recruiting patient volunteers. GFR>45ml/min within 2 weeks of enrollment, Patient has medical record visible within the EHR of participating sites, BMI >= 25kg/m2 by self-report height/weight or >= 23kg/m2 in patients who self-identify in S. Asian or Latinx background.59-61, Willing and able to comply with study procedures, Has an address and electronic device for communication. Metformin use started in France in 1957, but it was not introduced in the United States until 1995, nearly 20 years after the biguanide phenformin was taken off the market because of its risk of lactic acidosis, which was often fatal." Clinical trials are research studies that involve people. Drugs used in chemotherapy, such as docetaxel, carboplatin, trastuzumab, pertuzumab, and pegfilgrastim, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. : Estimated Glomerular Filtration Rate (eGFR) of < 45ml/min/1.73 m2, Other kidney disease that in the opinion of the investigator would affect clearance, Electronic medical record history of severe liver disease, Other liver disease that in the opinion of the investigator, would affect metformin clearance, Documented AST or ALT > 3 times the upper limit of normal within 3 months of randomization (if available in electronic medical record), Enrollment in another blinded RCT for COVID, Patients taking these medications: cimetidine, hydroxychloroquine, insulin, sulfonylurea, dolutegravir, patiromer, ranolazine, tafenoquine. Aims/hypothesis: The aim of this study was to compare the efficacy and safety of once-weekly albiglutide with once-daily insulin glargine (A21Gly,B31Arg,B32Arg human insulin) in patients with type 2 diabetes inadequately controlled on metformin with or without sulfonylurea. Participants in the PEP cohort of the trial are those who do not test positive for SARS-COV-2 infection at the time of screening but had a close exposure to SARS-CoV-2 infected person (defined by current CDC definition of close contact). COVID-19 is an emerging, rapidly evolving situation. You may want to think about taking part in a clinical trial. Under review, in adults with non-alcoholic fatty liver disease and +SARS-CoV-2, OR for admission: 0.42 (0.18-1.01, p=0.05). Clinical trials are research studies that involve people. Participants in this arm and group will receive the placebo. Outpatient metformin use has now been associated with lower IL-6, CRP, and neutrophil-lymphocyte ratio in persons with Covid-19. Inclusion Criteria, Stage 1 Treatment Trial: Exclusion Criteria, Stage 1 Treatment Trial: To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Symptom onset greater than 7 days before randomization (symptoms not required for inclusion). Metformin hydrochloride is primarily used to treat and prevent type 2 diabetes. article Effect of metformin on the survival of patients with ALL who express high levels of the ABCB1 drug resistance gene. +PCR) within 3 days of randomization; negative antibody test not required. A clinical trial is a way to carefully test a new drug or device in patients before it is approved by the FDA to be used in the general public. article Outcome is reported as the change in serum viral load (copies per ml of blood) from baseline to 5 days and baseline to 10 days. Clinical trial for Diabetes Type 2 , A Double-Blind Randomized Active-Comparator (Metformin) Controlled Clinical Trial to Study the Efficacy and Safety of the Strategy to Start Patients With Type 2 Diabetes Mellitus on Janumet Compared to Metformin Location: Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, This phase III trial studies how well metformin hydrochloride works compared to placebo in preventing breast cancer in patients with atypical hyperplasia or in situ breast cancer. Lilly posts results of all registered Lilly-sponsored clinical trials. Other companies, including San Francisco-based Enlibrium, also have plans to evaluate metformin derivatives for use in oncology. In contrast, clinical trials of metformin in pancreatic cancer did not show a survival benefit . For Covid-19 Symptoms (as defined by current CDC definition of Covid-19 symptoms). Metformin; immediate release formation; 1,500mg daily. Diabetes Mellitus Type 2 Clinical Trials. Get the latest research information from NIH: You have reached the maximum number of saved studies (100). Tax ID# 13-3813813 Location: 3 locations, This phase I trial studies the side effects and best dose of metformin and nelfinavir in combination with bortezomib in treating patients with multiple myeloma that has come back or does not respond to treatment. This ground breaking clinical trial, called Targeting Aging with Metformin (TAME) will test whether metformin can delay the onset of age-related diseases and conditions including cancer, cardiovascular disease and Alzheimer’s disease. DPP Study Design. Giving metformin hydrochloride together with combination chemotherapy may kill more tumor cells. Type1 diabetes usually develops in children or young adults and requires daily insulin to survive. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. One of the first cancer clinical trials of a metformin analogue – IM-156, from the American Houston-based biotech Immunomet – is set to start in Korea in the first half of 2018. Nelfinavir and bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Chemoprevention is the use of certain drugs to keep cancer from forming. Location: Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire, Clinical Trials Using Metformin Hydrochloride, Complementary & Alternative Medicine (CAM), Coping with Your Feelings During Advanced Cancer, Late Effects of Childhood Cancer Treatment, Frederick National Laboratory for Cancer Research, Milestones in Cancer Research and Discovery, Tech Transfer & Small Business Partnerships, Step 1: Application Development & Submission, How to Work With Your Health Insurance Plan, Questions to Ask about Treatment Clinical Trials, Drugs Approved for Different Types of Cancer, Drugs Approved for Conditions Related to Cancer, I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer, Chemotherapy with or without Metformin Hydrochloride in Treating Patients with HER2 Positive Breast Cancer That Can Be Removed by Surgery, Metformin Hydrochloride, Cisplatin and External Beam Radiation Therapy in Treating Participants with Stage III-IV Head and Neck Squamous Cell Cancer, Metformin Hydrochloride and Levonorgestrel-Releasing Intrauterine System in Treating Patients with Atypical Endometrial Hyperplasia or Endometrial Cancer, Metformin, Nelfinavir, and Bortezomib in Treating Patients with Relapsed and / or Refractory Multiple Myeloma, Metformin Hydrochloride and Doxycycline in Treating Patients with Localized Breast, Uterine, or Cervical Cancer, Metformin Hydrochloride and Combination Chemotherapy in Treating Patients with Stage III-IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer, Metformin Hydrochloride in Treating Patients with Relapsed Chronic Lymphocytic Leukemia or Untreated Chronic Lymphocytic Leukemia with Genomic Deletion 11q, Metformin Hydrochloride in Mitigating Side Effects of Radioactive Iodine Treatment in Patients with Differentiated Thyroid Cancer, Metformin Hydrochloride in Preventing Breast Cancer in Patients with Atypical Hyperplasia or In Situ Breast Cancer, Effects of Metformin Hydrochloride in Participants with Malignant Solid Tumors, U.S. Department of Health and Human Services. 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