Diabetes & Endocrine System

Pathway to Prevention

TrialNet is an international network dedicated to the study, prevention, and early treatment of type 1 diabetes. TrialNet sites are located throughout the United States, Canada, Finland, United Kingdom, Italy, Germany, Sweden, Australia, and New Zealand. TrialNet is dedicated to testing new approaches to the prevention of and early intervention for type 1 diabetes

Primary disease category:

DIabetes study of liNAgliptin and eMpagliflozin in children and adOlescents (DINAMO)

The purpose of this research study is to evaluate the efficacy and safety of an empagliflozin dosing regimen and one dose of linagliptin in patients with type 2 diabetes who are aged 10 to below 18 years and are currently taking metformin, insulin or both drugs (DINAMO TM) or who are treatment naïve or not on active treatment after metformin withdrawal (DINAMO TM MONO) .

Primary disease category:

Diabetes & Endocrine System

Understanding insulin resistance in obesity and type 2 diabetes

The molecular nature of insulin resistance in human muscle is still incompletely defined. For almost thirty years we have been trying to understand the mechanisms that explain why muscle in patients who are obese or have type 2 diabetes only poorly uses fat for fuel. We termed this metabolic inflexibility. This causes fat to build up in muscle and other tissues, and causes the patient to respond poorly to insulin. We now think there are two proteins, called ANT1 and VWA8, that might be responsible for at least part of this.

Primary disease category:

Diabetes & Endocrine System

Secondary disease category(ies):

Healthy Volunteers

Late Stage, Complex Non-healing Diabetic Foot Ulcers (AMBULATE DFU II)

Phase 3 study will look at a population of diabetic foot ulcer patients having adequate perfusion, with
or without neuropathy, and a high suspicion of associated osteomyelitis in a complex high grade wound. The study will look at the application of human placental umbilical cord tissue to the surface of a well debrided, complex diabetic foot ulcer (DFU) will, with concomitant management of infection, result in a higher rate of wounds showing omplete healing within 25 weeks of initiating therapy, compared with
standard care alone.

Primary disease category:

Diabetes & Endocrine System

Integra DFU

Researchers want to find out more about a device called PriMatrix® Dermal Repair Scaffold. PriMatrix is an
approved device for treatment of diabetic foot ulcers as well as other medical problems.
The main purpose of this study is to see if PriMatrix® Dermal Repair Scaffold is effective in the management of
diabetic foot ulcers in subjects with diabetes and without significantly decreased blood flow. In addition, safety
will be evaluated.

Primary disease category:

Diabetes & Endocrine System

Secondary disease category(ies):

Diabetes & Endocrine System

Safety and Efficacy Study of VM202 in the Treatment of Chronic Non-Healing Foot Ulcers

phase III, randomized, double-blind, placebo-controlled, multicenter, 7-month study designed to assess the safety and efficacy of intramuscular (IM) injections in the calf of VM202 in patients with chronic nonhealing foot ulcers. Three hundred patients will be randomized in a 2:1 ratio of VM202 or placebo injections:

Active -VM202 + standard of care - 200 patients
Control - Placebo (VM202 Vehicle) + standard of care - 100 patients

Primary disease category:

Diabetes & Endocrine System

Family Routines Enhancing Adolescent Diabetes by Optimizing Management

We are looking for families with a child or adolescent with a diagnosis of type 1 diabetes to participate in a study examining the effects of an intervention to assist families with their daily routines. Assessments and the intervention consultation address sleep, school, and family activities that may help or interfere with diabetes management.

Primary disease category:

Diabetes & Endocrine System

Secondary disease category(ies):

Children, Infants & Newborns

NN1218-4131 Efficacy and Safety of Faster-acting Insulin Aspart compared to NovoRapid® both in combination with Insulin Degludec in Adults with Type 1 Diabetes

The purpose of this trial is to confirm the efficacy and safety of faster-acting insulin aspart as mealtime insulin as well as postmeal injected insulin in combination with insulin degludec in subjects with T1DM. The results will be used in the registration file in Japan and label updates globally on use of faster aspart in combination with insulin degludec. In the European Medicines Agency (EMA) and FDA note for guidance on clinical investigation of
medicinal products for the treatment of diabetes, HbA1c is considered the most widely accepted

Primary disease category:

Diabetes & Endocrine System

Evaluation of the metformin scavenging mechanism on methylglyoxal in patients with type 2 diabetes mellitus

This study will evaluate the effect of metformin at the usual target dose for patients with prediabetes and patients wirh type 2 diabetic on the plasma methylglyoxal (MG) and urine metformin-MG IMZ cyclized product (IMZ) levels, which will be compared to the MG and IMZ levels of the matched non-diabetic patients

Primary disease category:

Diabetes & Endocrine System

A Randomized Phase II Study of Temozolomide or Temozolomide and Capecitabine in Patients with Advanced Pancreatic Neuroendocrine Tumors

The purpose of this study is to compare the effects, good and/or bad, of temozolomide versus temozolomide plus capecitabine on the subjects and the subjects’advanced pancreatic neuroendocrine tumor cancer to find out which is better. In this study, subjects will get either temozolomide alone or temozolomide and capecitabine. Temozolomide and capecitabine are chemotherapy drugs, which have benefited some patients with pancreatic neuroendocrine tumors yet they have never been compared; both arms are considered investigational.

Primary disease category:

Diabetes & Endocrine System

Secondary disease category(ies):

Cancer, Brain & Other Nervous System Cancers

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