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Diabetes Mellitus, Type 2 clinical trials

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NCT ID: NCT01127269 Completed - Clinical trials for Diabetes Mellitus, Type 2

Safety and Effectiveness Study of Insulin Glargine (LANTUS) Initiation and Titration in Patients With Type 2 Diabetes

AFICIONADO
Start date: May 2010
Phase: Phase 4
Study type: Interventional

Primary Objective: Percentage of patients achieving Glycosylated Hemoglobin (HbA1c) < 7% with no severe or nocturnal hypoglycemic episodes at 6 months Secondary Objectives: - Glycosylated Hemoglobin (HbA1c) change from baseline to 6 months - Insulin glargine dose at 3 and 6 months - Hypoglycemic episodes (all types)

NCT ID: NCT01126580 Completed - Clinical trials for Diabetes Mellitus, Type 2

A Study in Participants With Type 2 Diabetes Mellitus (AWARD-3)

Start date: May 2010
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine if LY2189265 is safe and effective in reducing glycosylated hemoglobin (HbA1c) as compared to metformin in participants with Type 2 Diabetes.

NCT ID: NCT01125969 Completed - Diabetes Mellitus Clinical Trials

A Trial of Incentives and Peer Mentors to Improve Diabetic Outcomes

Start date: March 2011
Phase: N/A
Study type: Interventional

In recent years, social networks have garnered attention in both academic journals and the lay press because of strong associations demonstrated in retrospective studies between social networks and incidence of major health problems such as obesity and smoking. Financial incentives have also been demonstrated to improve health behaviors in obesity, smoking, and medication adherence. We propose to conduct a randomized controlled trial among a predominantly African American population with persistently poor diabetes mellitus (DM) control to examine whether two novel interventions, lottery based financial incentives and telephone based one-on-one peer mentoring (the 'buddy system'), can significantly ameliorate disparities in poor DM control. The intervention is based on epidemiologic evidence, randomized controlled trials, and pilot studies demonstrating: 1) Lottery based financial incentives are a powerful motivator of behavior change; 2) One-on-one peer mentoring is a flexible, cost-efficient means of increasing DM specific social support and may be particularly salient in minority communities; and 3) Matching patients with poorly controlled DM with a similar individual from their community who has gained control of their DM draws on existing community assets in creating an inherently culturally competent intervention. DM patients with poor DM control will be randomized to 1 of 4 arms: usual care; telephone based one-on-one peer mentoring; lottery based financial incentives; and peer mentoring plus financial incentives. The Specific Aims are to test: 1) The effectiveness of telephone based one-on-one peer mentoring in improving glycemic control relative to usual care; 2) The effectiveness of lottery based financial incentives in improving glycemic control relative to usual care; 3) The effectiveness of combining peer mentoring and financial incentives relative to control; and 4) The relative cost effectiveness of all four approaches. In exploratory analyses, we will examine whether African American patients enrolled in intervention arms have greater improvement in glycemic control than white patients, whether intervention group patients experience greater improvements in blood pressure (BP) and lipid control, and whether peer mentors experience improvements in their own health. We will pair mentors with mentees based on race, gender, age, and disease severity. The active intervention will be run for a 6-month time period, with participants followed for an additional 6 months to determine if effects persist post intervention. The proposed interventions address multiple barriers to effective disease management common among patients with DM. If effective, these interventions could provide important models for improving glycemic control in general and, in particular, for addressing racial disparities in DM outcomes.

NCT ID: NCT01125956 Completed - Diabetes Mellitus Clinical Trials

Improving Diabetes Control Through Peer Counseling and Incentives

Start date: July 2009
Phase: N/A
Study type: Interventional

The specific aims of this study are to test whether in a cohort of low-income minority veterans with poor diabetes mellitus (DM) control: 1. Peer counseling is an effective means of reducing HbA1c (a measure of glucose control). 2. Financial incentives are an effective means of reducing HbA1c. This is a randomized controlled pilot study. There will be 3 arms: 1) a control group of poorly controlled diabetics getting usual care; 2) peer counseling with no incentives; and 3) financial incentives without peers. Ultimately, contingent on the success of this intervention, the researchers plan to apply for funding for a large scale intervention employing both peer counseling and incentives to improve DM control in low income and minority patients who are at high risk for premature morbidity and mortality.

NCT ID: NCT01125553 Completed - Healthy Clinical Trials

A Comparison Between Two Formulations of NN5401 in Healthy Subjects

Start date: May 2010
Phase: Phase 1
Study type: Interventional

This trial is conducted in the United States of America (USA). The aim of the trial is to compare the exposure of two formulations of insulin degludec/insulin aspart (NN5401) in healthy subjects.

NCT ID: NCT01123980 Completed - Clinical trials for Diabetes Mellitus, Type 2

Comparison of the Blood Sugar Lowering Effect of Biphasic Insulin Aspart 30 and Insulin Glargine Both Combined With Metformin and Glimepiride in Chinese and Japanese Subjects With Type 2 Diabetes New to Insulin Treatment

EasyMix
Start date: May 2010
Phase: Phase 4
Study type: Interventional

This trial is conducted in Asia. The aim of this clinical trial is to investigate the blood sugar lowering effect of biphasic insulin aspart 30 once daily compared to insulin glargine once daily both in combination with metformin and glimepiride in Chinese and Japanese subjects with type 2 diabetes who have never received insulin before. The trial is conducted as a phase 4 trial in China and phase 3 in Japan.

NCT ID: NCT01123239 Completed - Clinical trials for Diabetes Mellitus, Type 2

Understanding and Improving Diabetes Care for Ethnic Minorities

R2D2C2
Start date: January 2006
Phase: N/A
Study type: Interventional

In this study, we are testing the effectiveness of an intervention known as "Coached Care" to improve health outcomes and quality of care of patients being treated for type 2 diabetes, particularly patients in underserved populations. The intervention involves training members of minority communities who have diabetes to be "coaches", teaching minority patients the skills needed to participate effectively in care during office visits, as they present for those visits. Coaches follow patients for 9 routine consecutive visits, reinforcing participation skills before and between their routine office visits.

NCT ID: NCT01123083 Completed - Clinical trials for Diabetes Mellitus, Type 1

Trial of Otelixizumab for Adolescents and Adults With Newly Diagnosed Type 1 Diabetes Mellitus (Autoimmune): DEFEND-2

DEFEND-2
Start date: May 17, 2010
Phase: Phase 3
Study type: Interventional

DEFEND-2 is a Phase 3 confirmatory study for the Phase 3 DEFEND-1 study. The study objective is to find out if an 8-day series of otelixizumab infusions leads to greater improvement in insulin secretion as compared with placebo. Insulin secretion will be assessed using mixed meal-stimulated C-peptide. Subjects will be assigned to receive either otelixizumab or placebo at a ratio of 2:1 (2/3 otelixizumab, 1/3 placebo). These study agents will be administered as an addition to insulin, diet, and other standard of care treatments.

NCT ID: NCT01122979 Completed - Clinical trials for Diabetes Mellitus, Type 2

Evaluation of the Safety and Efficacy of Insulin Glargine + Glulisine or Insulin Regular + NPH Insulin (Isophane Insulin) Use in Type 2 Diabetes Mellitus Patients With Moderate Renal Failure.

DINAMO
Start date: July 2010
Phase: Phase 4
Study type: Interventional

Primary Objective: >To obtain an estimation for both treatment groups of the proportion of patients that reach the target of HbA1c <= 7% without confirmed nocturnal hypoglycaemia in each treatment group. Secondary Objectives: - Glycemic control, measured by HbA1c and FPG (fasting plasma glucose) at baseline and after each period of treatment. - Incidence of confirmed symptomatic and nocturnal hypoglycemia. - Incidence of confirmed severe hypoglycemia (< 36mg/dL or need of help to recover). >Weight variation for each period of treatment. - Creatinine clearance at baseline and after each period of treatment. - Overall safety: Incidence of adverse events.

NCT ID: NCT01122316 Completed - Heart Failure Clinical Trials

Management of Diabetes With Metformin In Patients With Chronic Heart Failure

Start date: September 2009
Phase: N/A
Study type: Interventional

The Ahmanson-UCLA Cardiomyopathy Center is conducting a clinical research study that will assess the use of the medication metformin to improve quality of life, exercise capacity, and improved outcomes with patients that have both heart failure and diabetes. If you participate in this study, you will receive the drug metformin for approximately 3 months. During the study you will undergo comprehensive testing which includes blood draws, an echocardiogram, and an magnetic resonance imaging (MRI)(if you do not have a pacemaker or defibrillator). You will also fill out a questionnaire and keep a blood glucose log. You must be 18 years old to participate. The study drugs, study follow-up visits, and laboratory tests will be provided free of charge. Participants will be reimbursed up to $200 for their time and travel expenses.