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Diabetes Mellitus, Type 2 clinical trials

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NCT ID: NCT02128932 Completed - Clinical trials for Diabetes Mellitus, Type 2

Efficacy and Safety of Semaglutide Once Weekly Versus Insulin Glargine Once Daily as add-on to Metformin With or Without Sulphonylurea in Insulin-naïve Subjects With Type 2 Diabetes

SUSTAIN™ 4
Start date: August 4, 2014
Phase: Phase 3
Study type: Interventional

This trial is conducted in Africa, North and South America, Asia and Europe. The purpose of the trial is to compare the effect of once-weekly dosing of two dose levels of semaglutide versus insulin glargine once-daily on glycaemic control after 30 weeks of treatment in insulin-naïve subjects with type 2 diabetes.

NCT ID: NCT02128854 Completed - Clinical trials for Diabetes Mellitus, Type 2

Tablet-Aided BehavioraL Intervention EffecT on Self-management Skills

TABLETS
Start date: August 14, 2014
Phase: N/A
Study type: Interventional

The purpose of this project is two-fold: (1) to determine the feasibility of recruiting rural African American (AA) adults in South Carolina (SC) for assessing the usefulness of tablet-based resources in good diabetes self-management behaviors, and (2) to test a tablet-aided intervention for improving diabetes self-management behaviors

NCT ID: NCT02128581 Completed - Obesity Clinical Trials

A Dose-response of the Effects of Exendin-9,39 on GI Symptoms and Food Intake

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

Exendin-(9,39) has been shown to have effects on beta-cell function, and after gastric bypass, to accelerate gastrointestinal transit. - infused at rates of 300pmol/kg/min. Given that gastrointestinal transit is typically delayed by Glucagon-Like Peptide-1 (GLP-1) and also that this hormone causes decreased food intake through increased satiation, it is reasonable to expect an effect of Exendin-9,39 on appetite. This may help explain the effects of gastric bypass on food intake. To examine the effect of Exendin on food intake we propose a dose-response study to determine whether the compound has effects in a dose-dependent fashion. We will examine the presence of gastrointestinal symptoms as well as food intake in the immediate aftermath of a test meal and the subsequent hours.

NCT ID: NCT02127762 Completed - Diabetes Mellitus Clinical Trials

The Effect of Mindfulness Based Stress Reduction in Patients With Painful Diabetic Peripheral Neuropathy

AWARE
Start date: September 2012
Phase: N/A
Study type: Interventional

By 2020, it is estimated that 3.7 million Canadians will have diabetes mellitus, with type 2 diabetes (T2DM) accounting for more than 90% of cases. Estimates of the prevalence of diabetic peripheral neuropathy among adults with T2DM range from 26% to 47%. It increases with patient age and duration of disease and it can be as high as 60 to 70% in older cohorts. Diabetic peripheral neuropathy is documented in most studies as numbness, tingling, pain and/or objective sensory changes. Pain is an early manifestation of neuropathy and may be the presenting symptom of diabetes. Even the best medications and procedures rarely relieve more than 30% of the discomfort of chronic painful conditions. Diabetic patients continue to experience debilitating and disabling pain. Pain affects our ability to work, our ability to participate in recreational activities, our mood and our relationships. It is well-established that an interdisciplinary approach is key to the treatment of some types of chronic pain, but little research has been done on the effectiveness of interdisciplinary treatments for patients suffering from painful diabetic peripheral neuropathy. The investigators will evaluate the effectiveness of an interdisciplinary approach combining medical treatment and mindfulness-based stress reduction (MBSR) to reduce disability and improve quality of life among patients with painful diabetic peripheral neuropathy. The investigators will also evaluate the impact of the program on psychological distress, pain cognitions, and biomarkers of stress and glycemic function.

NCT ID: NCT02127047 Completed - Clinical trials for Diabetes Mellitus Type 1

Effects of Exercise and Inhibition of Dipeptidyl Peptidase-4 on Insulin Secretion in Subjects With Type 1 Diabetes

EXTYPE-1
Start date: November 2013
Phase: Phase 2
Study type: Interventional

Increasing evidence suggests pancreatic islet beta-cell regeneration occurs throughout the course of the disease in patients with type 1 diabetes. Therefore, decreased beta-cell mass in type 1 diabetes may be improved through inhibition of beta-cell destruction and stimulation of proliferation, even after prolonged duration of disease. Physical activity improves insulin secretion via unknown underlying mechanisms. We recently observed that Interleukin-6 induces glucagon like Peptide (GLP)-1 production and release from the islet alpha-cell and the intestinal L-cell. Furthermore, exercise induces release of Interleukin-6 from skeletal muscle resulting in elevated circulating Interleukin-6 levels. Therefore we hypothesize that exercise-induced Interleukin-6 promotes glucagon like peptide-1 secretion from the islet α-cell and the intestinal L-cell, thereby providing a mechanism how physical activity can help maintain and improve beta-cell function in patients with type 1 diabetes. This mechanism can be enhanced by concomitant dipeptidyl peptidase-IV inhibition. Physical activity is also known to enhance insulin sensitivity and to attenuate the immune system activity. Therefore by combining physical activity and dipeptidyl peptidase-IV inhibition we aim to allow for beta-cell regeneration in a interventional randomized open-label study.

NCT ID: NCT02123628 Completed - Diabetes Mellitus Clinical Trials

Antibiotic Treatment Duration for Non-Surgically-Treated Diabetic Foot Osteomyelitis

C H R O N O S
Start date: June 2007
Phase: Phase 4
Study type: Interventional

The purpose of the study is to compare the efficacy and tolerance of 6- versus 12-week antibiotic therapy in patients with diabetic foot osteomyelitis treated medically.

NCT ID: NCT02123563 Completed - Obesity Clinical Trials

Mechanical-chemical Gingival Therapy in Diabetics and/or Obese

MCGTDO
Start date: June 2012
Phase: Phase 4
Study type: Interventional

Diabetes and obesity affect many people in different countries. Similarly, millions of people have some type of gum disease such as gingivitis. The present study was conducted to clarify if systemic conditions such as diabetes and obesity could impair the response to gingivitis treatment. Subjects with gum disease showing diabetes type II (from 40 to 50 subjects), slight to moderate obesity (from 40 to 50 subjects) or its combination (from 40 to 50 subjects) were selected for the present study. In addition normal-weight subjects with gum disease (from 40 to 50 subjects) besides a group without gum disease (from 40 to 50 subjects) were selected for comparisons. After verbal and written explanations about the study, subjects who matched study criteria and who signed the informed consent form underwent full oral examinations in two separate visits. In the first visit, after a clinical examination to verify the levels of gingival inflammation and the accumulated amounts of dental plaque, the bone height was determined by X-Ray examinations. Bad breath was also evaluated by a chair-side apparatus. Additional laboratorial examinations included a) quantification of bacteria that cause gum disease from dental plaque samples, b) quantification of inflammatory products from gingival fluid sampling and c) quantification of produced saliva. Self-report questionnaires were used to check the impact of oral condition and treatment of gum disease in quality of life and individual daily performance. These examinations were repeated 3 months after dental treatment. All subjects received ultrasonic dental prophylaxis for cleaning their teeth. Based on systemic/oral conditions each group rinsed either an essential-oils containing mouth rinse or a placebo rinse. First rinse was supervised and the other ones were performed at home twice a day for three months. Each participant also received a toothbrush, a dental floss and a fluoride toothpaste monthly after oral hygiene instructions. Adherence to the treatment and occurrence of undesirable side effects were monitored throughout the study.

NCT ID: NCT02123251 Completed - Diabetes Mellitus Clinical Trials

Hawaii Patient Reward And Incentives to Support Empowerment

HI-PRAISE
Start date: May 2014
Phase: N/A
Study type: Interventional

The purpose of this randomized controlled trial (RCT) study is to examine the extent that financial incentives when combined with diabetes evidence-based practices, improve self-management and biometric measures for adult diabetic Medicaid recipients with an HbA1c of ≥ 6.5 at enrollment. The study will also evaluate the cost-effectiveness of the program. Specific Aims: 1. Evaluate whether financial incentives for completing American Diabetes Association (ADA) recommended tests, exams, health education, biometric outcome goals, and vaccinations will improve primary biometric outcomes. 2. Evaluate whether financial incentives for completing ADA recommended tests, exams, health education, biometric outcome goals, and vaccinations will improve diabetes patients' self-management as assessed by Summary of Diabetes Self-Care Activities Measure (SDSCA) and 36-Item Short Form Health Survey (SF36v2). 3. Evaluate the extent to which financial incentives for healthy behaviors reduce the cost of health care utilization.

NCT ID: NCT02121483 Completed - Clinical trials for Diabetes Mellitus, Type 2

Pharmacokinetic Single Dose Trial of Empagliflozin in Children and Adolescents With Type 2 Diabetes Mellitus

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

The aim of the study is to generate pharmacokinetic and pharmacodynamic data to identify the safe-effective dose of empagliflozin in children and adolescents aged 10 to less than 18 years with type 2 diabetes mellitus.

NCT ID: NCT02119819 Completed - Clinical trials for Diabetes Mellitus, Type 2

A Study to Compare a New Drug for Type 2 Diabetes to Placebo and to a Treatment Already Available for Type 2 Diabetes

Start date: April 2014
Phase: Phase 2
Study type: Interventional

The main purpose of this study is to compare the safety and effectiveness of the study drug known as LY2944876 to exenatide extended-release and placebo in participants with type 2 diabetes mellitus. All drugs will be given by an injection under the skin. Participants remain on stable doses of metformin, as prescribed by their personal investigator if they were on metformin at study entry. Participants' involvement in the study is expected to last about 30 weeks.