[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Yanbing Li\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":88},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,40,62],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100651977","mazdutide-for-remission-of-type-2-diabetes-multicentre-double-blind-randomised-placebo-controlled-trial-100651977",false,"NCT07767552","Mazdutide for Remission of Type 2 Diabetes: Multicentre, Double Blind, Randomised, Placebo Controlled Trial","Inclusion Criteria:\n\n1.T2D was diagnosed according to WHO standards in 1999. 2.18 years to 70years when signing the informed consent form. 3.Diet and exercise intervention alone before screening, or stable metformin (≥500 mg\u002F day and ≤2000mg\u002F day for at least 4 weeks), or a stable dose of SGLT2 inhibitor (minimum maintenance dose: Empagliflozin 10 mg\u002F day, dapagliflozin 5 mg\u002F day, canagliflozin 100 mg\u002F day, constant agliflozin 5 mg\u002F day, and etoagliflozin 5 mg\u002F day for at least 4 weeks) were still not well controlled after monotherapy, and the local laboratory test at screening was 6.5%≤HbA1c≤9.0%.\n\n4.Duration of type 2 diabetes ≤5 years at screening. 5.BMI≥24 kg\u002Fm2 at screening. 6.A stable diet and exercise lifestyle could be maintained during the study period.\n\n7.Subjects voluntarily sign informed consent and agree to strictly follow the requirements of this protocol.\n\nExclusion Criteria:\n\n1\\. Subjects who are considered by the investigator to be potentially allergic to the components of the study drug or to the drug in the same class.\n\n2.Weight change \\> 5% in 12 weeks before screening (chief complaint). 3. Use of any of the following drugs or treatments before screening:\n\n1. Use of a GLP-1R agonist or GLP-1R\u002FGCGR (glucagon receptor) agonist or GIPR (glucose-dependent insulinotropic polypeptide) within 2 months before screening receptor) \u002FGLP-1R agonist or GIPR\u002FGLP-1R\u002FGCGR agonist; Participants who discontinued a drug more than 2 months before screening because of lack of efficacy or intolerance were also excluded.\n2. Oral antidiabetic drugs other than background medications within 2 months before screening.\n3. Use of insulin for diabetes control within 3 months before screening, except for short-term use of insulin in acute conditions (cumulative ≤14 days), such as acute illness, hospitalization, or elective surgery. The interval between the last insulin treatment and screening day was less than 14 days.\n4. Weight-loss medications used within 1 month before screening or planned to be used during the trial, such as semaglutide, benaglutide, liraglutide, orlistat, sibutramine hydrochloride, phenylpropanolamine, chlorbendazole, phenylbutamine, lorcaserin hydrochloride, phentermine, phentermine\u002Ftopiramate, bupropion, and naltrexone\u002Fbupropion.\n5. Use of Chinese herbal medicine, other traditional medicines and health products with hypoglycemic effect within 2 months before screening.\n6. were receiving chronic (\\> 2 weeks) systemic glucocorticoids or had received glucocorticoids within 4 weeks before screening (topical, intraocular, intranasal, or inhaled administration were excluded).\n7. current use of central nervous system stimulants, excluding caffeinated beverages, at the time of screening.\n8. have participated in another clinical trial and received a trial drug within 3 months before screening.\n9. History of alcohol and drug abuse at screening. Mean weekly alcohol intake: more than 21 units for men and 14 units for women (1 unit = 360 ml of beer, or 150 ml of red wine, or 45 ml of distilled\u002Fliquor).\n\n4\\. There is a history or evidence of any of the following diseases:\n\n1. Previously diagnosed with type 1 diabetes (including latent autoimmune diabetes in adults, LADA), or positive for glutamic acid decarboxylase antibody (GADA) and other islet-related antibodies.\n2. Complications of diabetes occurred within 30 days before screening (ketosis acidosis, hyperosmolar diabetic state, or lactic acidosis).\n3. History of severe hypoglycemic episodes within 30 days before screening, defined as presenting with neurological hypoglycemic symptoms and requiring assistance from others to recover, or having no awareness of hypoglycemia or insufficient understanding of hypoglycemic symptoms in the past. Subjects who the researchers consider unable to communicate and understand hypoglycemic symptoms and appropriate treatment should also be excluded from this study.\n4. Previous history of acute or chronic pancreatitis, or blood amylase or lipase \\> 2.0×upper limit of normal value (ULN) during the screening period, or fasting triglycerides ≥ 5.64 mmol\u002FL (500 mg\u002Fdl).\n5. Previous history of gastroparesis or bariatric surgery, or clinically significant gastric emptying abnormalities as determined by the researcher.\n6. Previous proliferative diabetic retinopathy, or diabetic macular edema, or rapid progression of non-proliferative diabetic retinopathy or requiring urgent treatment.\n7. Acute or chronic hepatitis (except chronic hepatitis B), symptoms and signs of other liver diseases, or ALT \\> 3.0×ULN (ALT \\> 5.0×ULN for non-alcoholic fatty liver disease), or AST \\> 3.0×ULN, or total bilirubin (TBIL) \\> 2.0×ULN.\n8. Previous personal or family history of medullary thyroid carcinoma, patients with multiple endocrine neoplasia type 2, or serum calcitonin ≥ 50 ng\u002FL (pg\u002FmL), or thyroid function-related indicators TSH \\> 6 mIU\u002FL or \\\u003C 0.4 mIU\u002FL.\n9. Hyperthyroidism or hypothyroidism confirmed by clinical assessment and\u002For abnormal thyroid stimulating hormone (TSH) as determined by clinical evaluation, except for subjects on stable thyroid hormone replacement therapy for at least 2 months with normal thyroid function and expected unchanged dosage throughout the study period.\n10. Previously diagnosed with autonomic neuropathy, manifested as urinary retention, resting tachycardia, orthostatic hypotension, or diabetic diarrhea.\n11. Had a severe cardiovascular or cerebrovascular event within 3 months before screening.\n12. 12-lead ECG at screening shows a heart rate \\\u003C 50 beats\u002Fmin or \\> 100 beats\u002Fmin, ECG indicates active heart disease, or the researcher considers the ECG abnormality at screening would interfere with the interpretation of ECG results during the subsequent follow-up, especially excluding QTcF \\> 500 ms.\n13. Poorly controlled hypertension, systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg; or had adjusted antihypertensive drugs (dose or type) within 30 days before screening; evidence of renal artery stenosis, or unstable blood pressure (including orthostatic hypotension, etc.).\n14. Had active or untreated malignant tumors within 5 years before screening, or in a clinical remission period (skin basal cell carcinoma and squamous cell carcinoma, cervical carcinoma in situ, prostate carcinoma in situ, or papillary thyroid carcinoma with no recurrence after surgery, except for subjects without recurrence) during the screening period. 15) During the screening process, if the estimated glomerular filtration rate (eGFR) is less than 45 mL\u002Fmin\u002F1.73 m2, it is calculated using the CKD-EPI formula (see Appendix 2).\n\n16\\) A history of atopic reactions (clinical manifestations of severe or multiple allergies), or a clinically significant history of multiple or severe drug allergies, or intolerance to topical glucocorticoids, or severe post-treatment hypersensitivity reactions (including but not limited to erythema multiforme, linear immunoglobulin A dermatitis, toxic epidermal necrolysis, allergic reactions, angioedema or exfoliative dermatitis).\n\n17\\) Evidence of previous or during the screening period human immunodeficiency virus (HIV) infection or positive HIV antibody, or hepatitis B (HBV) antibody, or hepatitis C (HCV) antibody, or positive syphilis antibody.\n\n18\\) History of organ transplantation (except corneal transplantation), or preparing for organ transplantation.\n\n19\\) During the screening process, the investigator considers that there is a serious active and uncontrolled physical condition or history that may place the participant at risk during the use of the study drug or interfere with the interpretation of the efficacy and safety data of this study.\n\n20\\) A history of mental illness during the past or during the screening period, and the investigator considers that the participant is not suitable to participate in this study.\n\n21\\) Within the previous 3 months, the blood donation volume and\u002For blood loss volume was ≥ 450 mL or there was bone marrow donation, blood transfusion or severe blood loss, or there was hemoglobinopathy, hemolytic anemia, sickle cell anemia, or the blood hemoglobin was \\\u003C 110g\u002FL (for males) or \\\u003C 100g\u002FL (for females) during the screening, or there were any other known factors that may interfere with the HbA1c test results; 5. Pregnant or lactating women, or men or women with reproductive capacity who are unwilling to use contraception throughout the study period until 8 weeks after the end of the study.\n\n6\\. The investigator considers that the subject has any other factors that may affect the efficacy or safety evaluation of this study and is not suitable to participate in this study.","ALL","18 Years","70 Years",{"count":19,"type":20},249,"ESTIMATED","INTERVENTIONAL",[23],"NA","The purpose of this study is to investigate and efficacy of Mastitide for diabetes remission in Chinese type 2 diabetic subjects with poor glycemic control on diet or exercise therapy alone or metformin\u002Fsodium-glucose cotransporter (SGLT2) inhibitor monotherapy.",[26],"Diabetes Mellitus, Type 2","NOT_YET_RECRUITING","2026-08-11",{"date":30,"type":31},"2026-08-17","ACTUAL",{"date":33,"type":20},"2026-09-30",{"date":35,"type":20},"2029-06-30",{"name":37,"class":38},"Yanbing Li","OTHER",1,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":47,"targetDuration":4,"studyType":21,"phases":49,"briefSummary":51,"conditions":52,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":55,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":4},"100606296","phase-4-regimen-transition-after-short-term-intensive-insulin-therapy-in-type-2-diabetes-100606296","NCT07173712","Regimen Transition After Short-Term Intensive Insulin Therapy in Type 2 Diabetes","Regimen Transition After Short-Term Intensive Insulin Therapy in Type 2 Diabetes Mellitus Patients With Inadequate Glycemic Control on Oral Hypoglycemic Agents: A Multicenter, Open-Label, Randomized Controlled Study","Inclusion Criteria:\n\n1. Diagnosed with type 2 diabetes mellitus (T2DM) with a disease duration of \\>1 year and \\\u003C15 years.\n2. On a stable dose of at least one oral antidiabetic drug (OAD) for ≥3 months.\n3. HbA1c at screening: \\>8.0% if on a single OAD; \\>7.5% if on more than one OAD (centralized laboratory testing, or results from medical centers participating in the National Glycohemoglobin Standardization Program).\n4. Age 18-70 years.\n5. Body mass index (BMI) 20-35 kg\u002Fm².\n6. Able and willing to comply with study requirements, including continuous glucose monitoring, self-monitoring of blood glucose, lifestyle management, and insulin-based glycemic management.\n7. Agreement to use effective contraception during the study.\n8. Willingness to provide written informed consent.\n\nExclusion Criteria:\n\n1. Diagnosis of type 1 diabetes mellitus or other specific types of diabetes.\n2. Receipt within 3 months prior to screening of premixed insulin therapy and\u002For basal-bolus insulin therapy and\u002For basal insulin plus OAD therapy for ≥7 cumulative days; or receipt within 1 year prior to screening of intensive insulin therapy (insulin pump or multiple daily injections); or receipt within 3 months prior to screening of GLP-1 receptor agonists; or inability to tolerate protocol-specified doses.\n3. Known hypersensitivity or intolerance to study medications.\n4. Acute diabetic complications (including diabetic ketoacidosis, hyperosmolar hyperglycemic state, or lactic acidosis).\n5. Severe microvascular complications: proliferative diabetic retinopathy; albumin excretion rate (AER) \\>300 mg\u002Fg or proteinuria \\>0.5 g\u002Fday; uncontrolled painful diabetic neuropathy or significant autonomic neuropathy. Severe macrovascular complications: hospitalization for acute cerebrovascular accident, acute coronary syndrome, peripheral artery disease requiring intervention or amputation within the previous 12 months; unstable angina, myocardial infarction, uncontrolled arrhythmia, or severe heart failure (New York Heart Association \\[NYHA\\] class ≥III).\n6. Persistent blood pressure \\>180\u002F110 mmHg, or uncontrolled above 160\u002F110 mmHg within 1 week.\n7. Estimated creatinine clearance \\\u003C45 mL\u002Fmin\u002F1.73 m² (calculated by CKD-EPI formula); alanine aminotransferase ≥2.5 × upper limit of normal (ULN); or total bilirubin ≥1.5 × ULN.\n8. Hemoglobin \\\u003C100 g\u002FL or requiring regular blood transfusions.\n9. Use within 12 weeks prior to screening of medications affecting glycemic control for \\>1 cumulative week, including oral\u002Fintravenous glucocorticoids, growth hormone, estrogen\u002Fprogestins, high-dose diuretics, or antipsychotics. Exceptions: low-dose diuretics used for antihypertensive purposes (HCTZ \\\u003C25 mg\u002Fday, indapamide ≤1.5 mg\u002Fday) and physiological thyroid hormone replacement therapy.\n10. Uncontrolled endocrine disorders.\n11. History or family history of medullary thyroid carcinoma, or history of multiple endocrine neoplasia syndrome type 2 (MEN2).\n12. Psychiatric illness or communication disorders.\n13. Systemic infection, severe comorbid conditions, malignancy, or chronic diarrhea.\n14. Pregnancy, lactation, or women of childbearing potential unwilling to use contraception during the study.\n15. Uncooperative participants, inability to comply with follow-up, or judged by investigators as unlikely to complete the study.\n16. Any other condition deemed unsuitable by investigators, including history of acute pancreatitis, rapidly progressing gallstones, or chronic cholecystitis.",{"count":48,"type":20},324,[50],"PHASE4","Failure of oral antidiabetic drugs (OADs) is a frequent challenge in patients with type 2 diabetes mellitus (T2DM), and inadequate long-term glycemic control substantially increases the risk of diabetic complications. Short-term intensive insulin therapy (SIIT) is an established approach to mitigate glucotoxicity; however, the optimal strategy to sustain long-term glycemic benefits after SIIT in T2DM patients with OAD failure remains unclear. To address this gap, we designed a randomized controlled trial to evaluate subsequent treatment options, aiming to identify a simple and effective regimen for patients with poor glycemic control who undergo SIIT.\n\nA total of 324 eligible patients will be enrolled. After screening, previous antidiabetic regimens will be discontinued, and patients will be randomly assigned to the SIIT- iGlarLixi group (A), the SIIT-IDegAsp group (B), or the SIIT-iGlar group (C). All patients will be hospitalized for short-term insulin pump therapy, followed by 24 weeks of treatment: group A with insulin glargine\u002Flixisenatide, group B with insulin degludec\u002Faspart, and group C with insulin glargine U300 plus metformin. During the extension follow-up period, patients in all groups may either continue their assigned regimen or return to their original pre-study therapy. A total of 10 clinic visits are scheduled for each patient throughout the study.\n\nPrimary endpoint is proportion of patients achieving glycosylated hemoglobin A1C \\\u003C7% at 24 weeks.Secondary endpoints include proportion of patients achieving glycosylated hemoglobin A1C \\\u003C6.5% at 24 weeks; differences in weight gain, hypoglycemic events among treatment groups, and differences in proportion of patients continuing the assigned regimen, glycemic control and body weight at the extension follow-up period.",[53],"Type 2 Diabetes","2026-02-04",{"date":56,"type":31},"2026-02-06",{"date":58,"type":20},"2026-03-15",{"date":60,"type":20},"2027-12-31",{"name":37,"class":38},{"id":63,"slug":64,"hasResults":11,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":68,"eligibilityCriteria":69,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":70,"targetDuration":4,"studyType":72,"phases":4,"briefSummary":73,"conditions":74,"keywords":75,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":86,"locationsCount":87},"100608236","cofrogliptin-and-linagliptin-as-add-on-therapy-to-insulin-in-type-2-diabetes-100608236","NCT07198932","Cofrogliptin and Linagliptin as add-on Therapy to Insulin in Type 2 Diabetes","Effectiveness and Safety of Cofrogliptin and Linagliptin as add-on Therapy to Insulin in Chinese Adults With Type 2 Diabetes Mellitus: a Multicenter, Prospective Real-world Study (COLOR-REAL)","COLOR-REAL","Inclusion Criteria:\n\n1. Sign the informed consent form.\n2. Aged ≥18 years.\n3. Diagnosed with type 2 diabetes mellitus (meeting the 1999 WHO diagnostic criteria).\n4. Recently tested HbA1c 7%-9% and FPG ≤11 mmol\u002FL, with stable treatment using insulin ± OADs for at least 12 weeks prior to enrollment. Insulin regimens are limited to: basal insulin once daily or once weekly, premixed insulin once or twice daily, or IDegAsp once or twice daily. OAD classes are limited to metformin, SGLT2 inhibitors, and α-glucosidase inhibitors and with no more than three agents in total.\n5. Willing to start or have already initiated cofrogliptin or linagliptin treatment (at the physician's discretion in accordance with clinical practice). The treatment decision is independent of study enrollment, must be made before signing the informed consent, and cofrogliptin or linagliptin initiation must occur either within 2 weeks before or within 2 weeks after signing the informed consent.\n\nExclusion Criteria:\n\n1. Allergic to the study drug.\n2. Diagnosed with type 1 diabetes.\n3. Unable to comply with study-specific procedures.\n4. Current or planned pregnant, or currently breastfeeding.\n5. With any other situation judged by the investigator, that is unsuitable for participation in this trial.",{"count":71,"type":20},594,"OBSERVATIONAL","This study is a multicenter, prospective, non-interventional real-world study to evaluate the clinical outcomes of biweekly cofrogliptin versus daily linagliptin as an add-on therapy in Chinese adult T2D patients.",[53],[76,77,78,79],"real-world study","cofrogliptin","DPP-4i","insulin","2025-09-28",{"date":82,"type":31},"2025-09-30",{"date":84,"type":20},"2025-10-01",{"date":60,"type":20},{"name":37,"class":38},7,""]