Active clinical trials for "Diabetes Mellitus"

Primary Objective: To evaluate the effect of virtual approach via novel technologies versus traditional study conduct on glycemic control in terms of glycated hemoglobin (HbA1c). Secondary Objective: To evaluate the appropriate utilization of virtual approach via novel technologies during the study and to assess the effect of the virtual versus traditional study conduct on multiple outcomes in terms of study methodology and diabetes management.

This is a phase 1, randomized, double-blind, placebo-controlled study to evaluate the safety and tolerability of REGN1193 in patients with Type 2 Diabetes Mellitus.

Pilot study to compare the efficacy and safety of a premixed-insulin regimen (70% intermediate insulin and 30% regular insulin) to a basal-bolus insulin regimen (glargine once daily and glulisine before meals) hospitalized patients with type 2 diabetes.

This randomized, double-blind, placebo-controlled, multi-center study will evaluate the efficacy and safety of RO6807952 in patients with diabetes mellitus type 2 inadequately controlled with metformin alone. Patients will be randomized to receive doses of RO6807952, placebo, or liraglutide. The anticipated time on study treatment is 12 weeks.

The purpose of this study is to assess whether Cinnamon bark or water-soluble cinnamon is an effective nutraceutical for the initial treatment of diabetes when compared to standard therapy of Metformin.

New onset diabetes after transplantation (NODAT) is a frequent and feared complication after kidney transplantation and leads to an increase in cardiovascular complications as well as in the rate of graft loss. Very little data exist on how patients in which NODAT has been diagnosed should be treated. It is suspected that Cylosporine A (Sandimmun, TM) is less diabetogenic than Tacrolimus (Prograf, TM). Furthermore, it has been described that early initiation of insulin treatment in Diabetes mellitus type 2 can preserve and improve the function of the insulin secreting cells in the pancreas. Therefore, the investigators test the effects of conversion from Tacrolimus to Cyclosporine A in patients with newly diagnosed NODAT who have just started early treatment with insulin. The hypothesis is that patients who are treated with insulin and who are switched to Cyclosporine A have improved glucose metabolism compared to patients who are treated with insulin and who remain on Tacrolimus therapy.

- Rationale: Treatment with glucagon-like peptide 1 (GLP-1) has been shown to reduce plasma glucose levels to a further extent when added to standard therapy in type 2 diabetes mellitus. Given the well-known beneficial effects of GLP-1 analogues on glucose metabolism by stimulating insulin release, suppressing elevated glucagon levels, delaying gastric emptying and reducing food intake, it is anticipated that liraglutide developed by Novo Nordisk (Victoza®) also has beneficial effects in type 2 diabetes mellitus as has been proven by several trials. Type 2 diabetes mellitus is associated with obesity and sedentary lifestyle. Obesity occurs when energy intake exceeds energy expenditure (EE) over a period of time. It has been presumed that activity energy expenditure and daily energy expenditure are lower in most people in Western societies. Increasing non-exercise activity thermogenesis (NEAT), defined as all energy expended due to everyday activity, exclusive of volitional exercise, may be an effective way to maintain daily EE and combat overweight and obesity. One way to promote NEAT is to decrease the amount of time spent on sedentary behaviors (e.g. watching television). This leads us to hypothesize that adding NEAT to GLP-1 analogues in type 2 diabetes has an additive effect on glucose regulation, weight control and blood pressure. On the other hand, we hypothesize that a decrease in HbA1c, weight and blood pressure could add to an improved quality of life and less health care costs. Therefore, the primary purpose of this study is to determine the synergistic effect of liraglutide and activating lifestyle by increasing NEAT on glucose metabolism and weight. First line therapy of type 2 diabetes mellitus currently consists of lifestyle changes with metformin. When failure of this regime occurs, sulfonylurea derivates and/or thiazolidinediones can be added. One third of patients with type 2 diabetes mellitus fail with this regimen after 5 years of monotherapy, and nowadays GLP-1 analogues can be added to prevent deterioration of glycaemic control. However, comparison of this strategy with NEAT has not been performed and the synergistic effect of combination of GLP-1 with increasing NEAT has not been investigated. Treatment with GLP-1 analogues in combination with NEAT could theoretically overcome all shortcomings of current treatment strategies of type 2 diabetes mellitus. Objective: Primary objectives To determine the change in HbA1c from baseline and end of treatment (26 weeks) and end of follow-up (52 weeks) after 26 weeks of treatment with liraglutide versus liraglutide with NEAT To determine the change in weight from baseline and end of treatment (26 weeks) and end of follow-up (52 weeks) after 26 weeks of treatment with liraglutide versus liraglutide with NEAT Secondary objectives To assess the change in blood pressure from baseline and end of treatment (26 weeks) and end of follow-up (52 weeks) after 26 weeks of treatment with liraglutide versus liraglutide with NEAT To assess the change in quality of life from baseline and end of treatment (26 weeks) and end of follow-up (52 weeks) after 26 weeks of treatment with liraglutide versus liraglutide with NEAT To assess the change in NEAT from baseline and end of treatment (26 weeks) and end of follow-up (52 weeks) after 26 weeks of treatment with liraglutide versus liraglutide with NEAT To asses the health-care related costs at baseline, after 26 weeks of treatment with liraglutide versus liraglutide with NEAT, and after 52 weeks (end of follow-up) Study design: Randomized controlled intervention study - Study population: Men and women with type 2 diabetes mellitus, insufficiënt glycaemic control during maximum (tolerable) dose monotherapy with metformin or a sulfonylurea derivate or during combination therapy with metformin and a sulfonylurea derivate or a thiazolinedione, HbA1c above 7,0%, age between 40 - 75 years old, BMI above 25 kg/m2 Intervention: One group receives once daily subcutaneously liraglutide 1.8mg added to standard anti-diabetic care and the other group receives once daily subcutaneously liraglutide 1.8mg added to standard anti-diabetic care and an activating lifestyle by increasing NEAT Main study parameters/endpoints: The main study parameter is the percent change in HbA1c and weight. Secondary study parameters are change in blood pressure, quality of life as measured using EQ-5D and SF-36 questionnaire, NEAT as measured using an activPAL™ accelerometer and cost-effectiveness analysis.

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics following ascending multiple doses of AMG 876 in subjects with type 2 diabetes.

The purpose of this study is to evaluate the efficacy of fasiglifam (TAK-875) plus metformin compared with sitagliptin plus metformin on glycemic control over a 24-week Treatment Period.

The purpose of this study is to evaluate the effect of TAK-875 (fasiglifam) in combination with sitagliptin on glycemic control in adults with type 2 diabetes.