Active clinical trials for "Diabetes Mellitus, Type 2"

The purpose of this study is to assess the effectiveness of the co-administration of canagliflozin and metformin extended release (XR) compared with canagliflozin alone, and metformin XR alone in patients with type 2 diabetes mellitus with inadequate control despite treatment with diet and exercise. The safety and tolerability of canagliflozin will also be assessed.

The major objective of this project is to determine if compared to Standard Care (SC), a Community Approach to Lifestyle Modification for Diabetes (CALM-D) program including diet, exercise and coping skills training, can decrease depression, weight and HbA1c and improve medication adherence in low income, primarily Black and Latino/Hispanic, depressed, overweight, Type 2 diabetic patients seen in a large, comprehensive, community health center. Type 2 diabetes is a major risk factor for coronary heart disease (CHD). Obesity, poor glycemic control, depression, low socioeconomic status (SES) and being a member of a racial/ethnic minority group all increase this risk. The project will compare 100 CALM-D and 100 SC participants. Following 3 run-in sessions assessment sessions to determine eligibility, given to both SC and CALM-D participants, SC patients will be treated in accordance with ADA Clinical Practice Guidelines (2005) and also assessed by project staff at baseline, 6 months and 1 year. The CALM-D participants will receive 2 individual stress management and lifestyle sessions followed by 2 weekly group sessions. Then 4 bi-weekly sessions will be followed by 9 monthly sessions for a total of 17 sessions. Secondary objectives of the project are to determine if compared to SC, CALM-D can improve glucose tolerance to challenge, insulin resistance, oxidative stress, inflammation, procoagulation, lipid profile, endothelial function resting blood pressure, cardiac and vascular function, cardiac morphology, psychosocial functioning and health quality of life. As many of the participants will already have been prescribed aspirin, statins, oral hypoglycemics and other medications, an important objective of the project will be to assess the extent to which improved adherence to medications - a goal of the CALM-D program - can account for improved intervention effects.

The purpose of this study is to evaluate the safety, tolerability, and efficacy of ISIS-PTP1BRx + oral antidiabetic drug/s (metformin and/or sulfonylurea) versus placebo + oral antidiabetic drug/s.

This study will test whether lowering the delivery of excess fats to the heart in persons with type-2 diabetes mellitus improves heart muscle function. The investigators will also test whether specific lipid molecular species in plasma can serve as biomarkers for diabetic heart disease.

This study evaluate the efficacy and safety of alogliptin and pioglitazone combination therapy in comparison with either alogliptin or pioglitazone on glucose control in the metformin-treated type 2 diabetic patients in Korea.

This three-year award will pilot-test an innovative intervention, Resilient, Empowered, Active Living with Diabetes (REAL), targeting underserved minority young adults with poorly-controlled diabetes. The individually tailored, community-based intervention merges findings of an in-depth needs assessment, principles of an evidence-based occupational therapy intervention (Lifestyle Redesign®) and evidence-based diabetes self-management strategies. A proof-of-concept study demonstrated that REAL is feasible to implement, acceptable to young adults with type 1 diabetes and type 2 diabetes, and has potential to produce positive changes in diabetes self-care and glycemic control. The study will randomize 80 young adults with diabetes to receive either the six-month REAL intervention or an attention control condition. Blinded data collectors will assess glycemic control, diabetes self-care behaviors and quality of life outcomes, as well as potential intervention mediators, before and after the six-month intervention. It is anticipated that findings from this pilot study will be used to inform a large-scale randomized controlled trial of the REAL intervention. The study's specific aims and hypotheses are as follows: Aim 1. Determine the intervention's efficacy for the primary outcomes: glycemic control and diabetes self-care. Hypothesis: At 6 months (immediately following the intervention), intervention group participants will demonstrate improvements in A1C and diabetes self-care as compared to control group participants. Aim 2. Conduct exploratory analyses of the intervention's impact on secondary outcomes and potential mediating mechanisms (to inform power estimates for a large-scale RCT). Hypothesis 1: At 6 months, intervention group participants will demonstrate improvements in secondary outcomes: diabetes-related stress and quality of life, depression, and life satisfaction as compared to control group participants. Hypothesis 2: At 6 months, intervention group participants will demonstrate improvements in potential mediators of the intervention: habit strength, problem solving, activity participation, self-efficacy and diabetes knowledge as compared to baseline. Aim 3. Conduct a process evaluation utilizing mixed methods to evaluate and refine intervention delivery (e.g. treatment fidelity, patient satisfaction) and study procedures (e.g. recruitment, retention, testing protocol).

Study to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of BI 44847 following administration of multiple rising oral doses over 8 days in patients with type 2 diabetes.

A study in type 2 diabetic subjects on stable metformin therapy to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of co-administering single and multiple oral doses of GSK1292263

The objective of the current study is to investigate the efficacy, safety and tolerability of linagliptin (5 mg / once daily) compared to placebo given for 24 weeks as add-on therapy to stable treatment in elderly patients with T2DM with insufficient glycaemic control

The purpose of this study is to evaluate the effectiveness of Self Monitoring of Blood Glucose (SMBG) for clinical decisions related to the management of type 2 diabetes and to determine the benefit of using Continuous Glucose Monitoring (CGM) for clinical diabetes management.