[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"glucose-high-blood\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:glucose-high-blood":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,43],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":27,"conditions":28,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100451511","phase-2-dose-response-study-of-transdermal-human-insulin-in-patients-100451511",false,"NCT05159453","Dose Response Study of Transdermal Human Insulin in Patients","A Randomised, Multiple-Dose, Single Period, Phase II\u002FIII Dose Response Study to Examine Transdermal Human Insulin in Adult Diabetic Patients","LEVPS","Inclusion Criteria:\n\n1. Adult Type 2 Diabetes Mellitus (\"T2D\") Patients on Insulin Replacement therapy not administered via implanted pump well-managing p.r.n as defined by serum glucose ranging between 85 and 200 mg\u002FdL and no more than 1 hypoglycemic or serious hypoglycemic event within the last 9 months.\n2. 25 and 75 years of age, inclusive.\n3. The subject is willing and able to read and understand the Subject Information Sheet and provide written informed consent.\n4. The subject has a body mass index (BMI) within 18-50 kg\u002Fm2.\n5. The subject is in otherwise good health as determined by medical history and physical examination.\n6. The subject's normal insulin dose ranges from between 10 to 200 IU per dose.\n7. The subject must agree to continue with daily serum glucose testing by means of a wearable blood glucose monitor for the pharmacodynamic assessments that the investigators have continuous access to via daily downloads.\n8. The subject is willing and able to comply with all testing and requirements defined in the protocol.\n9. The subject is willing and able to return to the study site for all visits.\n\nExclusion Criteria:\n\n1. The subject has any relevant deviations from normal other than blood glucose in physical examination, electrocardiogram (ECG), or clinical laboratory tests, as evaluated by the investigator.\n2. The subject has had more than 2 hypoglycemic events in the last month.\n3. The subject's normal insulin dose is less than 10 and more than 200 IUs.\n4. Subjects receiving Insulin from an implanted or external insulin pump system.\n5. The subject has had a clinically significant illness or surgical procedure within 30 days preceding entry into this study.\n6. The subject has a history of significant neurological, hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, or metabolic disease other than T2D.\n7. The subject has a known allergy or history of hypersensitivity to Human Insulin or similar modified Insulin compounds.\n8. The subject has used any prescription medication that may interfere with the evaluation of study medication.\n9. The subject has donated or lost a significant volume of blood (\\>450 mL) within four (4) weeks of the study, and subject's Hemoglobin concentration and hematocrit have not returned to within 5% of normal.\n10. The subject has a history of substance abuse or a current positive urine drug screen or urine alcohol test.\n11. Alcohol consumption greater than community norms (i.e. more than 21 standard drinks per week for males).\n12. Subjects who have received an investigational drug or have used an investigational device in the 30 days prior to study entry.","ALL","25 Years","75 Years",{"count":21,"type":22},30,"ESTIMATED","INTERVENTIONAL",[25,26],"PHASE2","PHASE3","A 21-Day open label study of transdermally delivered human insulin in Type 2 Diabetics as measured by response of down modulation of glucose after dosing of Insulin as compared to historic patient response to injected insulins.",[29],"Glucose, High Blood","NOT_YET_RECRUITING","2026-05-21",{"date":33,"type":34},"2026-05-26","ACTUAL",{"date":36,"type":22},"2027-09-02",{"date":38,"type":22},"2027-12-15",{"name":40,"class":41},"Transdermal Delivery Solutions Corp","INDUSTRY",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":50,"minAge":51,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":55,"phases":4,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":42},"100345971","metabolic-and-bone-changes-after-adjuvant-cancer-treatments-in-early-non-metastatic-breast-cancer-100345971","NCT03784651","Metabolic and Bone Changes After Adjuvant Cancer Treatments in Early Non-metastatic Breast Cancer","Metabolic and Bone Changes After Adjuvant Cancer Treatments in Early Non-metastatic Breast Cancer - a 5-year Follow-up Study.","Inclusion Criteria:\n\n* Postmenopausal\n* Breast cancer stage I-III\n* Eligible to receive (neo-)adjuvant chemotherapy\u002Fother antineoplastic treatment\n\nExclusion Criteria:\n\n* Prior malignancy\n* Metabolic disease (diabetes mellitus etc)","FEMALE","50 Years","70 Years",{"count":54,"type":22},120,"OBSERVATIONAL","Breast cancer is the most common cancer type in European women. Patients treated for early non-metastatic breast cancer comprise a growing group of survivors due to early diagnosis and improved treatment. Many of these survivors experience adverse effects such as decreased bone mineral density, derangement of metabolic markers (fat, glucose, insulin) and increased blood pressure. Increasing risk of bone fracture and cardiometabolic disease (eg. diabetes mellitus type 2).\n\nThe purpose of this study is to identify mechanisms behind cardiometabolic changes that may be connected to the (neo-)adjuvant treatment. On top of this we hope to indentify potential biological markers that can help prevent development of metabolic disease.\n\nWe will be recruiting 120 post-menopausal women age 50-70 with early breast cancer and 1-2 times a year for 5 years examine bone mineral density, body composition, glucose and fat metabolism and nerve damage. A questionnaire will be used to collect information on diet, physical activity and quality of life. Derudover anvendes spørgeskemaer til at indsamle information vedrørende. This new knowledge will help clinicians start adequate preventive measures to help patients avoid cardiometabolic disease secondary to cancer treatment.",[58,29,59,60,61],"Bone Fracture","Insulin Resistance","Blood Pressure, High","Cholesterolemia","RECRUITING","2021-09-14",{"date":65,"type":34},"2021-09-16",{"date":67,"type":34},"2018-12-17",{"date":69,"type":22},"2026-11",{"name":71,"class":72},"Rigshospitalet, Denmark","OTHER"]