Active clinical trials for "Diabetes Mellitus, Type 2"

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple ascending-doses of TAK-875 in subjects with type 2 diabetes mellitus.

The goal of this study was to determine the metabolic mechanism for a certain type medication's ability to lower blood sugar after a meal in Type 2 Diabetics, in order to develop a better understanding of it's potential role in the treatment of obesity.

To assess the relative bioavailability of dapagliflozin and metformin from the two FDC formulations, comprised of 10 mg dapagliflozin and 1000 mg metformin XR, relative to coadministration of a dapagliflozin 10 mg tablet and 2 x 500 mg Glucophage® XR tablets, in healthy subjects in a fasted state.

The purpose of this study is to determine the safety and tolerability of SRT2104 (0.03, 0.1, 0.25, 0.5, 1.0, 2.0, and 3.0 g/day) in healthy male volunteers when administered after a single dose and once daily for 7 consecutive days. The purpose is also to characterize the pharmacokinetic profile of SRT2104 (0.03, 0.1, 0.25, 0.5, 1.0, 2.0, and 3.0 g/day) after a single dose and multiple administrations in healthy male volunteers.

To characterize the steady-state pharmacokinetics (PK) of 2.5 mg saxagliptin administered twice daily with meals to healthy subjects

This study was set up to assess the effects of different doses of aspirin when compared with placebo (dummy drug), used sequentially over a 2 week study period with a 2 week wash-out (rest period) in between, in people with type-2 diabetes and high cardiovascular risk. Specifically, its effects on different factors which are thought to contribute to diabetes such as insulin resistance (body's ability to effectively use insulin), dysglycaemia (excess glucose in the blood), oxidative stress (effects from accumulation of by-products of metabolism), endothelial function (function of lining of blood vessels) and inflammation were studied.

The primary purpose of this study is to evaluate the safety and tolerability of SRT2104 (2.0 g administered once daily for 28 days) and to examine the effects of SRT2104 (2.0 g administered once daily for 28 days) on reversing vasomotor and fibrinolytic dysfunction in both type 2 diabetes mellitus patients and otherwise healthy cigarette smokers in a fed state. This study will investigate the effects of SRT2104 on the reduction of platelet activation markers (platelet-monocyte aggregates), and to evaluate the effects of SRT2104 on platelet and monocyte surface markers (P-selectin, CD11b), inflammatory markers (high sensitivity CRP, IL-6, SAA, TNF-α and sCD40L), and markers of oxidative stress (urinary and plasma F2-isoprostanes and nitrotyrosine). Further goals of this study is to characterize the pharmacokinetic profile of SRT2104 after a single dose and multiple administrations in both type 2 diabetes mellitus patients and otherwise healthy cigarette smokers in a fed state, and to explore the effects of SRT2104 on potential biomarkers of activity for glucose control (HbA1c, glycated albumin and fructosamine) and/or Sirt1 activation.

This study will be conducted in type 2 diabetic patient's to evaluate the if there is a different response of serum lipids after a standard meal (rich in saturated fatty acids) in patients who have the presence of a genetic alteration. This alteration that will be evaluated is a polymorphism, change of an amino acid in the gene of FABP2. This gene that can influence the absorption of lipids in the intestine and subjects who have the altered genotype (presence of T allele) can have an abnormal lipid profile as compared to subjects without this genotype.

Behavior change and self-efficacy are key for patients with diabetes to sustain blood sugar goals, but most care systems do not provide effective support to assist patients in successful ongoing self-management. After initial education, many programs are limited by allowable Medicare reimbursement for diabetes education which currently requires physician referral and cannot exceed two hours of training per year for a beneficiary, plus one hour of nutritional services. These services are usually provided either on an individual basis or occasionally through a traditional group class approach. For patients with established type 2 diabetes who are not achieving optimal glycemic control, we propose to develop and formally evaluate in a randomized trial a novel group experience to educate and motivate patients with established type 2 called IDEA, (Interactive Dialogue to Educate and Activate). This multi-site, randomized, prospective trial will randomize 621 patients with inadequately blood sugar control levels to one of 3 study groups: (1) IDEA - patients receive group sessions totaling 8 hours, with an average of 10 patients per group, using conversation maps as a conduit to facilitate dialogue between providers and patients (2) Individual Education (IE) - patients receive 2 hours with a nurse educator and 1 hour with a dietitian, and (3) Usual care (UC)- patients receive no research intervention. The primary analyses will involve mixed model regression to assess whether IDEA improves outcomes compared to IE and UC. Blood sugar level, blood pressure, and lipids will be evaluated 6 and12 months post-randomization and behavioral, emotional, and satisfaction outcomes through survey at baseline, 3, 6, 9 and 12 months. Depending on 12 month results, a longitudinal four year post intervention analysis is planned to assess sustainability of treatment effects and cost-effectiveness.

Patients with type 2 diabetes mellitus suffer from accelerated coronary artery disease. We will assess the effects of exercise training on coronary endothelial function, vascular structure, and inflammation both in serum and skeletal muscle biopsies, as well as expression of diabetes candidate genes.