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Diabetes Mellitus, Type 2 clinical trials

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NCT ID: NCT02001480 Completed - Clinical trials for End Stage Renal Disease

Surrogate Markers for Sudden Cardiac Death in Patients With Diabetes Mellitus and End Stage Renal Disease

Start date: October 2013
Phase: N/A
Study type: Interventional

Aim: Patients with type 2 diabetes mellitus (T2DM) and hemodialysis due to diabetic nephropathy exhibit a high risk for sudden cardiac death (SCD). Preliminary data suggest that beta-blocker treatment may reduce arrhythmias and mortality in this high-risk population. However, no results from large-scale clinical outcome trials with beta-blockers exist in this patient group and a broad, scientifically unapproved use of beta-blocker treatment may not be justified due to potential harmful side-effects such as AV-block or hypotension. In addition, we are lacking identified ECG surrogate parameters for SCD in this high-risk population and on the occurrence of arrhythmias in temporary relationship to hemodialysis sessions. Therefore, the present study will identify surrogate parameters of SCD in hemodialysis patients with T2DM and in an interventional trial investigate the suppressive effect of beta-blockers on these identified ECG markers.

NCT ID: NCT02001337 Completed - Diabetes Mellitus Clinical Trials

Examination of the Pancreas in New-onset Diabetes

EXPAND
Start date: May 2013
Phase:
Study type: Observational

The purpose of this study is to create a prospective cohort of subjects with increased probability of being diagnosed with pancreatic cancer and then screen this cohort for pancreatic cancer

NCT ID: NCT02000817 Completed - Clinical trials for Diabetes Mellitus, Type 1

Investigation of Otelixizumab in New-Onset, Autoimmune Type 1 Diabetes Mellitus Patients

Start date: March 12, 2014
Phase: Phase 1/Phase 2
Study type: Interventional

The aim of this Phase I/IIa study is to identify a safe and tolerable dosage regimen of intravenously administered otelixizumab. In addition, the C-peptide decline in new onset type 1 diabetes mellitus (NOT1DM) patients and possible immunological mechanisms will be investigated with a view to identifying trends and early immunological biomarkers which could predict response in halting/slowing Beta-cell destruction in this patient population. This exploratory study will explore the safety and tolerability between the well tolerated but non-efficacious cumulative dose of 3.1 mg and a cumulative dose of 48 mg at which efficacy based on C-peptide analysis was demonstrated, albeit with evidence of Epstein Barr Virus (EBV) reactivation and Cytokine Release Syndrome (CRS). Exploration of the tolerability dose response is considered a necessary first step to determining the therapeutic index of otelixizumab.

NCT ID: NCT02000700 Completed - Clinical trials for Diabetes Mellitus, Type 2

A Study to Evaluate the Pharmacokinetics, Pharmacodynamics and Safety of Canagliflozin in Older Children and Adolescents With Type 2 Diabetes Mellitus

Start date: March 2014
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the pharmacokinetics (blood levels) and pharmacodynamics (the action or effects a drug has on the body) of canagliflozin in children and adolescents with type 2 diabetes mellitus aged 10 to 17 years (inclusive). Other purposes are to investigate safety and assess the ease of swallowing the tablets.

NCT ID: NCT01999322 Completed - Diabetes Clinical Trials

A Trial Evaluating Compatibility and Safety of FIAsp and Insulin Aspart With an External Continuous Subcutaneous Insulin Infusion System in Adult Subjects With Type 1 Diabetes

onset® 4
Start date: November 19, 2013
Phase: Phase 3
Study type: Interventional

This trial is conducted in Europe and the United States of America (USA). The aim of this trial is to evaluate compatibility and safety of FIAsp (faster-acting insulin aspart) and insulin aspart (NovoRapid®) with an external continuous subcutaneous insulin infusion (CSII) system in adult subjects with type 1 diabetes.

NCT ID: NCT01998269 Completed - Hypertension Clinical Trials

A Mixed Methods Approach to the Development and Testing of the Measure of Drug Self-Management (MeDS)

MeDS
Start date: November 2013
Phase: N/A
Study type: Observational

The study objective is to develop and test a Measure of Drug Self-Management for use in clinical settings among patients with hypertension and diabetes. While medication non-adherence is a highly recognized public health and patient safety concern, it is rarely assessed in a routine and consistent manner in clinical settings. With the aging of the US population and rising rates of chronic disease, an increasing number of adults are being prescribed multi-drug regimens that require greater self-management skills. Despite the complexity of medication use, adherence has most commonly been measured as a limited set of behaviors (i.e., filling a prescription, taking doses). This emphasis has, over time, simplified how we think of prescription (Rx) medication use and directed attention away from the full range of tasks associated with effective Rx self-management. The field of health literacy research has deconstructed these tasks in considerable detail in recent years, and can offer insight into a more comprehensive measurement of patients' outpatient Rx use. There is a clear need for a brief, yet inclusive, measure of adherence that can be used in clinical settings to routinely assess patients' use of complex Rx regimens. Such an assessment could be used to guide clinicians in addressing specific patient challenges to safe and appropriate medication use. In response to this need, our study proposes to develop a new assessment of medication self-management. This unique measure will utilize health literacy best practices to promote patient comprehension and ease-of-use; it will also be tailored to patients' actual regimens via electronic health record (EHR) data. Finally, the tool will be available in both English and Spanish to support use among diverse patient populations. Our study aims are to: 1. Develop and refine a Measure of Drug Self-Management (MeDS) prototype. 2. Inform the content, structure and delivery of the MeDS through targeted discussions with patients, providers and information technology specialists. 3. Test the reliability and validity of the MeDS among patients with diabetes and hypertension H1: The MeDS will strongly correlate with other self-report adherence measures.

NCT ID: NCT01997411 Completed - Clinical trials for Diabetes Mellitus, Type 1

Assessment of Intranasal Glucagon in Children and Adolescents With Type 1 Diabetes

Start date: November 2013
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this study was to assess how glucagon administered nasally, using a nasal dosing delivery device, works in children and adolescents compared with commercially-available glucagon given by injection. In addition, the safety and tolerability of glucagon given nasally was evaluated.

NCT ID: NCT01997281 Completed - Diabetes Mellitus Clinical Trials

The Effect of Dietary Fiber-enriched Cereals on Glycemic Control and Secretion of Gut Hormones

Start date: December 2013
Phase: N/A
Study type: Interventional

The aim of this study is to assess whether dietary fiber-enriched cereals effect on postprandial glucose levels and plasma glucagon-like peptide 1 (GLP-1) and/or glucose-dependent insulinotropic polypeptide (GIP) concentration in patients with type 2 diabetes mellitus.

NCT ID: NCT01997021 Completed - Diabetes Clinical Trials

Effects of Interrupting Sedentary Time on Glycemic Control in Older Overweight and Obese Adults

B-WELL
Start date: November 2013
Phase: N/A
Study type: Interventional

Increasing physical activity in older adults has important implications for treating obesity related metabolic conditions, however the interaction of aging- and obesity-related declines in physical function may make adding structured exercise particularly challenging for this group. Given these challenges, an alternative prescription to traditional structured exercise, may be short bouts of intermittent walking scattered throughout the day - this may be an effective strategy to increase physical activity, reduce sedentary behavior, and improve glycemic control in overweight/obese older adults. The purpose of this project is to determine how interrupting sedentary time with short bouts of moderate intensity walking affects important metabolic outcomes in older, overweight adults. It would also be of interest to compare the effects of short, frequent interruptions in sedentary behavior to a traditional exercise prescription (continuous 30 min walking bout) on metabolic outcomes (e.g., glycemic control, insulin sensitivity, and 24 h fat oxidation). Thus, the overall aims of the proposed research are to 1) Determine the effect of performing short bouts of moderate-intensity intermittent walking (IW) on glucose and insulin metabolism compared to uninterrupted sitting (US) in older overweight and obese adults. 2) To compare the effects of interrupting sedentary time (IW) vs. a traditional exercise prescription (continuous 30 m walk (CW)) on metabolism. The investigators hypothesize that interrupting sedentary time with intermittent walking will improve glucose and insulin metabolism compared to uninterrupted sitting and it will be as effective at improving metabolism as a single continuous 30 min walk.

NCT ID: NCT01995656 Completed - Clinical trials for Diabetes Mellitus, Type 2

A Study of LY3108743 in Healthy Participants and Participants With Type 2 Diabetes

Start date: December 2013
Phase: Phase 1
Study type: Interventional

The main purpose of this study is to evaluate the safety and tolerability of the study drug known as LY3108743 in healthy participants and in participants with type 2 diabetes. The study will also investigate how LY3108743 affects the levels of blood sugar and other naturally occurring substances (e.g. hormones that control the way sugar is used) in the body, how much of the study drug gets into the blood stream, and how long it takes the body to get rid of it. Information about any side effects that may occur will be collected. The study is expected to last approximately 7 to 8 weeks for each participant. The study will have up to 3 parts. Participants may enroll in only one part.