View clinical trials related to Type 2 Diabetes Mellitus.
Filter by:Primary Objective: To demonstrate the superiority of the insulin glargine/lixisenatide fixed ratio combination (FRC) versus GLP-1 receptor agonist (GLP-1 RA) in hemoglobin A1c (HbA1c) change. Secondary Objectives: To compare the overall efficacy and safety of the insulin glargine/lixisenatide FRC to GLP-1 RA on top of metformin (with or without pioglitazone, with or without sodium-glucose co-transporter 2 [SGLT2] inhibitor) in participants with type 2 diabetes. To evaluate safety, efficacy and other endpoints of FRC up to the end of the extension period.
Several mechanisms have been implicated in the pathophysiology of the complications of diabetes mellitus (DM), one of them is the formation and accumulation of a heterogeneous group of compounds called advanced glycation end products (AGEs). The interaction of these compounds with their receptor, the receptor for advanced glycation end products (RAGE) triggers several signalling pathways which will lead to increase in inflammatory molecules and enhanced reactive oxygen species. In addition, to the membrane receptor RAGE, there are two soluble forms, the soluble RAGE (sRAGE) and the endogenous secretory RAGE (esRAGE), these soluble receptors are capable to bind AGEs and block the AGE-RAGE axis. It has been observed that in diabetes the needs of thiamine are increased, and it could be an inhibition of the pentose phosphate pathway (thiamine is an essential cofactor in this pathway) and activation of other metabolic pathways among them AGEs formation. It has been proposed that supplementation of benfotiamine could decreased the risk of micro and macrovascular complications, and this could be in part because a decreased in the formation of AGEs. For this reason, the objective of this study was to evaluate the effect of benfotiamine on AGEs and its soluble receptors (sRAGE) in patients with type 2 diabetes. The specific objectives in the current study are: 1. To evaluate and compare clinical and anthropometric characteristics in type 2 DM patients with and without benfotiamine treatment. 2. To evaluate and compare in type 2 DM patients with and without benfotiamine treatment the following biochemical parameters: total AGEs, Carboxymethyl-lysine (CML), sRAGE, glucose, hemoglobin A1c, lipids (total cholesterol, C-HDL, C-LDL, and triglycerides). 3. To evaluate and compare dietary data such as dietary AGEs and macro and macronutrients in type 2 DM patients with and without benfotiamine treatment. Type of study: This is a randomized, controlled, double-blind clinical trial Methods 34 patients will be recruited, 17 per group. After signing the inform consent subjects will be assessed for inclusion criteria. Subjects meeting the inclusion criteria and those whom accept to participate will be randomized to receive either a placebo or benfotiamine treatment for 12 weeks. At the end of the 12 weeks all the basal assessments will be repeated.
This is a multi-center, randomized, open-label, parallel-group comparative, exploratory study to evaluate the effect of trelagliptin administered at a dose of 100 mg once weekly or alogliptin administered at a dose of 25 mg once daily for 4 weeks on glycemic variation in patients with type 2 diabetes mellitus using continuous glucose monitoring (CGM).
The purpose of this study is to investigate the effect of bexagliflozin compared to glimepiride as an add-on therapy to metformin in lowering hemoglobin A1c (HbA1c) levels in subjects with type 2 diabetes mellitus (T2DM).
Scientific evidence for the dietary treatment of type 2 diabetes (T2D) is insufficient. The study group hypothesizes that a lower carbohydrate content in the diabetic diet than the recommended 55 energy percentage (E%) will decrease the postprandial glucose excursion. This will reduce postprandial insulin concentration, which together with lower glucose concentration leads to less fat accumulation in the liver and muscle tissue, resulting in an improved insulin sensitivity which together with a reduced glucose load improves the glucose metabolism. This clinical study will examine in subjects with type 2 diabetes the effect of highly controlled dietary low carbohydrate intervention on metabolic pathways with respect to insulin action, pancreatic islet function, lipid metabolism, ectopic fat accumulation, incretin hormones, low grade inflammation in plasma and adipose tissue, novel measures of fatty acid metabolism, and heart rate variability, respectively. The studies exhibit the potential to reform dietary recommendation aiming to prevent and ameliorate type 2 diabetes.
What are the benefits of undergoing Roux-en-Y gastric bypass surgery in improving type 2 diabetes outside of weight loss alone?
The purpose of this study was to compare the effects of FX006 and Triamcinolone Acetonide Injectable Suspension, United States Pharmacopeia (USP) (referred to as TCA IR in the protocol) on blood glucose (BG) in patients with osteoarthritis (OA) of the knee and Type 2 diabetes mellitus (DM).
Primary Objective: To compare LixiLan to insulin glargine in glycated hemoglobin (HbA1c) change from baseline to Week 26 in patients with type 2 Diabetes. Secondary Objective: To compare the overall efficacy and safety of LixiLan to insulin glargine (with or without OADs) over a 26 Week treatment period in patients with type 2 Diabetes.
Primary Objective: To compare LixiLan to insulin glargine in glycated hemoglobin (HbA1c) change from baseline to week 26 in patients with type 2 diabetes mellitus. Secondary Objective: To compare overall efficacy and safety of LixiLan to insulin glargine over 26 weeks in patients with type 2 diabetes mellitus.
This study aims to assess the impact of 24-week treatment of dapagliflozin in type 2 DM(diabetes mellitus) patients on diastolic dysfunction. Primary endpoint is assessing the impact of 24-week treatment of dapagliflozin in type 2 DM patients on subclinical diastolic dysfunction assessed by supine bicycle diastolic stress echocardiography. Secondary endpoint is assessing the impact of 24-week treatment of dapagliflozin in type 2 DM patients on functional capacity, he impact of 24-week treatment of dapagliflozin in type 2 DM patients at resting diastolic function. This is single-center, randomized, double-blind, placebo-controlled, parallel-arm intervention study. This study is planned to evaluate the impact of dapagliflozin on diastolic dysfunction assessed. The dose of dapagliflozin will be 10 mg as approved. For assessment of diastolic dysfunction, supine bicycle stress exercise echocardiography was performed, and changes in diastolic functional reserve, VO2max, exercise time, and maximal exercise capacity were assessed before and after treatment. This study will be randomized, double blind, placebo controlled, to minimize the risk of bias.