Active clinical trials for "Diabetes Mellitus, Type 2"

The purpose of the trial is to assess the efficacy and safety of tirzepatide to dulaglutide in participants with type 2 diabetes and increased cardiovascular risk.

The primary objective of the study is to determine if treatment with high-dose aflibercept (HD) at intervals of 12 or 16 weeks provides non-inferior best corrected visual acuity (BCVA) compared to aflibercept dosed every 8 weeks. The secondary objectives of the study are as follows: To determine the effect of HD vs. aflibercept on anatomic and other visual measures of response To evaluate the safety, immunogenicity, and pharmacokinetics (PK) of aflibercept

Diabetes is the second leading cause of end stage renal disease in France (22% in the 2016 REIN register). In hemodialysis, its prevalence is higher, between 30-40% depending on the study. Associated with type 2 diabetes, a large number of patients present with overweight (body mass index or BMI> 25 kg / m2) which can lead to a temporary contraindication to kidney transplant by the surgeon, or even definitive once BMI is over 30 kg / m2. Indeed, above this threshold, patients are exposed to an increased risk of surgical complications (wall infections, suture release), hospitalizations and potentially transplant failure. A recent study based on the Kidney Registry showed that patients with a BMI> 31 kg / m2 were more likely to stay on dialysis than to benefit from a transplant whereas for each decrease of 1 kg / m2 of BMI, there is a 9-11% increase in the likelihood of being transplanted. The management of obesity in dialysis patients is important for reducing cardiovascular risks but also because it increases the chances of access to transplantation. However, current weight loss programs are disappointing. The changes in hygiene and diet rules integrated into a specialized monitoring program only allow a weight loss of 2 to 8% in 24 months for half of the patients. Bariatric surgery is, of course, a more effective alternative, but with a 10% risk of postoperative complications. Glucagon-Like Peptide 1 (aGLP1) analogues are a new class of antidiabetic drugs that have revolutionized the management of type 2 diabetes. In fact, they combine efficacy on glycemic control but also on weight loss. They are used in obese non-diabetic people in some countries, with a reduction in weight of up to 10 to 15% with certain molecules. In addition, they have shown an effect on reducing cardiovascular events in diabetics including with Chronic Kidney Disease CKD 3-4. AGPL1 are well tolerated with side effects mainly of digestive tropism such as nausea or vomiting. Exceptionally, these effects can occur from the first injection requiring permanent discontinuation of treatment. In 20% of cases, these side effects can appear in the first weeks. They gradually fade, spontaneously or after symptomatic treatment and allow titration of the drug. AGLP1 is currently contraindicated in patients with reduced renal function, that is, when the glomerular filtration rate (GFR) is <15 ml / min (MRC stage 5-5D), because this population specific was excluded from the originator studies. However, aGLP1 are small peptides that are not eliminated by the kidneys. Their elimination takes place through the general catabolism of proteins. To date, 2 publications have evaluated the safety profile and efficacy of an aGLP1, liraglutide (Victoza®), in diabetic dialysis patients. These studies showed that the 24 hour plasma concentration of liraglutide increased by 50% over the long term. The safety profile was acceptable with, as expected, a predominance of gastrointestinal effects in the first weeks of treatment such as nausea, vomiting. The authors suggest an adjustment of the dosages and a longer titration period to limit side effects. However, treatment with aGPL1 is effective with better glycemic control and an average weight loss of 2.6 kg over a period of 3 months. Studies show that weight loss under liraglutide continues beyond 3 months with possible losses between 4 and 8 kg at 6 months and 12 months of treatment followed 12. Liraglutide (Victoza®) is the analogue of GPL1 for which we have a sufficiently long follow-up (> 10 years) on its effectiveness and its short and long-term side effects. The main objective of this project, in type 2 diabetic patients on dialysis, as a temporary contraindication for transplant due to overweight, is on the one hand to study the effect of liraglutide on weight loss and control of diabetes, and on the other hand to assess its tolerance in this population. The expected benefit is to be able to facilitate registration on the waiting list and access to renal transplantation of these overweight patients, without having to resort to more invasive methods such as bariatric surgery.

Randomized clinical trial, international, multicentre, single-blind, two parallel groups, pragmatic. It will be carried out by investigators in several Latin American countries (Chile, Colombia, Mexico and Peru) and with random allocation 1:1 of the participants to Usual Care Group (UCG) or Intervention Group (IG). Each country will select 5 trial sites that will recruit 0-60 participants. Finally, 1050 subjects will be involved in the project. The primary outcome are the changes in function and quality of life as measured by changes in the scores used to assess them between baseline and 1-year follow-up. Function will be assessed by the Short Physical Performance Battery-SPPB. This study is focused on an older population (≥ 65 years) with diabetes and a frail or prefrail status The intervention includes: Educational program in small groups: 7 sessions in the clinical trial sites (2 sessions a week for the first 3-4 weeks) Exercise program (16 weeks): learning phases in clinical trial site for 3-4 first week (coincident with the educational program sessions) and the rest at home. Adaptation of targets of HbA1c and blood pressure (BP). UCG Usual care group consists in level of care usually given in Health Care system.

The purpose of this study is to assess the safety, efficacy, and durability of up to two REACT injections delivered percutaneously into biopsied and non-biopsied contralateral kidneys on renal function progression in two different cohorts of subjects with T1DM or T2DM and CKD.

Many with type 2 diabetes (T2D) remain sub-optimally controlled. Structured programmes requiring dietary and lifestyle intervention have been shown to improve control but are time-and labour-intensive. The role for self-monitoring of blood glucose with capillary blood glucose (CBG) readings is uncertain. The use of flash glucose monitoring (FGM) with education may effect improvements in awareness and self-management behaviour and hence glycaemic control. The investigators aim to compare the effects of FGM versus CBG fingersticks in the context of a structured education programme over a 6-month period in adults with type 2 diabetes. 200 adults (>21y) with sub-optimally controlled T2D (7.5-10%) on either diet-controlled, oral glucose lowering drugs or background insulin will be enrolled and randomised into the intervention arm (FGM and education) or control arm (capillary glucose fingersticks and education). The intervention arm will monitor glucose using FGM continuously for 6 weeks and intermittently thereafter up to 24 weeks. The control group will monitor glucose using CBG fingersticks up to 24 weeks. During the intervention period(0-24w), both arms will undergo the same schedule of visits (-2w, 0w, 8w, 16w, 24w) and 6 education sessions. Both groups will be followed up at weeks 38 and 52. Primary outcome is HbA1c change from baseline at 24 weeks. This study will provide novel data on the use of FGM versus CBG in Type 2 diabetes and its impact on glycaemic control.

The VICTOR study plans to include rural communities served by Colorado Heart Healthy Solutions (CHHS) program and find out whether participants will accept a referral to a comprehensive virtual lifestyle intervention, Virta Health. The Virta Health program induces nutritional ketosis to improve glucose control in individuals with type 2 diabetes. The study will inform the acceptability of the referral, the retention of participants in lifestyle intervention, and the durability of effects on glucose control after the lifestyle intervention has ended.

This research study is being performed to begin to determine the effectiveness of two dominant bariatric surgery procedures versus an intensive lifestyle intervention to induce weight loss in patients and promote improvements in Type 2 diabetes mellitus (T2DM) in moderately obese patients. T2DM is currently the 6th leading cause of mortality in the United States and is a major cause of kidney failure, blindness, amputations, heart attack, and other vascular and gastro-intestinal dysfunctions. Traditionally, treatments include intensive lifestyle modifications with or without glucose lowering agents. Neither treatment alone, or in combination, results in complete resolution of diabetes and its potential long-term complications. Bariatric surgery has been proven as an effective treatment to accomplish sustained and significant weight loss for those with severe obesity and has been shown to induce long-term remission of T2DM. However, despite enthusiasm for these potential treatment options, it is not clear whether diabetes is influenced by the type of surgery or by the amount of weight lost or if bariatric surgery is more effective than non-surgical weight loss induced by diet and physical activity in T2DM patients with moderate BMIs (30-40kg/m2; Class I and Class II obesity, or approximately 65-95 pounds overweight depending on your height). More well-controlled studies are needed to more completely inform health care decision making and clinical practice in this area. This research study aims to obtain preliminary information regarding the effectiveness of two major types of bariatric surgery, Laparoscopic Roux-en-Y Gastric Bypass and Laparoscopic Adjustable Gastric Banding versus an intensive lifestyle intervention to induce weight loss with diet and increased physical activity.

This study will evaluate safety, tolerability, pharmacokinetic (PK) profile, and pharmacodynamic (PD) effects on GSBR-1290 in healthy overweight/obese volunteers (HOV) and Type 2 Diabetes Mellitus on Metformin (T2DM) This study includes 5 planned cohorts. Participants will receive multiple-ascending doses of GSBR-1290 or Placebo from Day 1 to Day 84

Study will monitor weight loss and metabolic indicators for subjects in multi-center, single arm trial.