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The prevalence of type 2 diabetes mellitus (T2DM) has been increasing rapidly in China. China currently has ~130 million diabetes cases, and over 90% are T2DM. T2DM is a leading cause of morbidity and mortality, posing substantial clinical and public health challenges. Reversing T2DM with a significant amount of weight loss via consuming a low-calorie diet is possible, but no studies have been conducted to determine whether low-calorie diets will help achieve significant weight loss and diabetes remission among Chinese patients with T2DM. The investigators design a pilot study to assess the feasibility of a low-calorie diet intervention program on weight loss and diabetes remission in a Chinese population with T2DM.
A multicenter, randomized, placebo-controlled clinical trial, double-blind, parallel-group
The Impact of Metformin and Dipeptidyl Peptidase- 4 Inhibitors on Cognitive Function and cardiovascular protection in Type 2 Diabetic Patients
The purpose of this study is to evaluate the effect of probiotic supplementation on fecal microbiota, nutritional status, metabolic and inflammatory parameters in patients with type 2 diabetes mellitus. Study hypothesis: Supplementation of multispecies probiotic (Bifidobacterium Lactis, B. brebe, B. longum, Lactobacillus gasseri, L. casei, L. rhamnosus) during 12 weeks improves the the fecal microbiota composition and promotes reduction of plasma/serum levels of acute phase proteins, cytokines, metabolic and anthropometric parameters in individuals with type 2 diabetes mellitus.
In this multicenter, randomized, open-label, parallel-controlled, non-inferiority clinical trial, the efficacy and safety of insulin degludec/insulin aspart (IDegAsp) twice daily will be compared with degludec/insulin aspart (IDegAsp) once daily plus insulin aspart (IAsp) twice daily after 16weeks of treatment in patients with type 2 diabetes mellitus. This trial will enable primary assessment of the clinically relevant endpoint of a change in HbA1c.
To evaluate the bioequivalence of a single oral dose of HRX0701 tablets and the reference formulations retagliptin phosphate tablets and metformin hydrochloride tablets in healthy subjects in the postprandial state; To evaluate the pharmacokinetic effects of a high-fat diet on retagliptin and metformin after a single oral administration of HRX0701 tablets in healthy subjects.
This is a parallel-group treatment, Phase 3, randomized, 2-arm study to assess the efficacy and safety of iGlarLixi to IDegAsp in Chinese T2DM participants insufficiently controlled with oral antidiabetic drug(s). Study details include: - Study duration per participant: approximately up to 27 weeks - Treatment duration: 24 weeks - Visit frequency: after screening (an on-site visit), on-site or phone call visit every 1 week from randomization till Week 4, every 2 weeks till week 12 and then every 3 weeks till Week 24 (End of Treatment). There will be 14 visits including 7 phone call and 7 on-site visits in total during screening and treatment periods. There will be a safety follow-up by a phone call visit (End of Study) in 3 days after the last dose of the treatment. - Health measurement/Observation: change in HbA1c as the primary endpoint. - Intervention name: iGlarLixi and IDegAsp - Participant sex: male and female - Participant age range: adults at least 18 years of age - Condition/disease: Type 2 diabetes mellitus - Study hypothesis: Compared to IDegAsp, iGlarLixi will demonstrate a similar therapeutic effect on glycemic control assessed by change in HbA1c from baseline to Week 24 in the study participants.
Type-2 Diabetes Mellitus (DM) disease, like other chronic diseases, is a group of diseases that are adversely affected by the COVID-19 pandemic.This study was planned to examine the effect of COVID-19 disease on patients with Type-2 DM and to investigate the effects of progressive relaxation exercises to be given as tele-rehabilitative on stress, anxiety and blood glucose levels and HbA1c value.
This is a single-site, randomized, double-blinded, placebo-controlled, First-in-Human trial, conducted in 3 parts.
This is an observational study in which patients with chronic kidney diseases (CKD), type 2 diabetes (T2D) or heart failure (HF) who are current or past users of sMRA therapies are studied. sMRA stands for steroidal mineralocorticoid receptor antagonists. CKD is a long-term, progressive decrease in the kidneys' ability to work properly. Type 2 diabetes is a condition in which the body does not make enough of a hormone called insulin or does not use insulin well resulting in high blood sugar levels. HF is a condition in which the heart does not pump blood as well as it should. The renin-angiotensin-aldosterone system (RAAS) is a hormone system that works with the kidneys to control blood pressure and the balance of fluid and electrolytes (like salt) in the blood. The RAAS has been a treatment target of heart and kidney diseases for decades. One of these classes of medications is called mineralocorticoid receptor (MR) antagonists (MRAs). MRAs work to directly block the action of a hormone called aldosterone. Aldosterone is produced naturally by the adrenal glands, and it can increase the blood volume and blood pressure. Using MRAs therapies can help prevent strokes, heart attacks and kidney problems. Spironolactone was the first available MRA in the US with its approval in 1960. Eplerenone is another MRA which has been available since 2002. Both spironolactone and eplerenone are known as steroidal MRA (sMRA) due to their chemical structures. The main purpose of this study is to collect more data on the characteristics of patients who are taking sMRA currently and those who have discontinued sMRA therapy in the past 12 months. To do this, patients who have received sMRA in the most recent 12 months will be invited to participate in the study and asked to complete surveys if they agree to join the study. Patients will be found from administrative claims in a database called HealthCore Integrated Research Database (HIRD). And the other purposes of the study are to learn more about: - the indications for sMRA therapy - the frequency and symptoms of reported side effects of sMRA treatment - the treatment satisfaction and effectiveness as well as potential reasons for treatment continuation/discontinuation of sMRA therapies Besides this data collection, no further tests or examinations are planned in this study. The participants will receive their treatments as prescribed by their doctors during routine practice according to the approved product information. Researchers will look at the health information from adult men and women in the US only if applicable who are current/past users of sMRA therapies with diagnosis of CKD or T2D or HF, consent to participate in the study.