Effects of Structured Simplified Short-term Intensive Insulin Therapy on Long-term Glycemic Remission

• Status: Not yet recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Short-term intensive insulin therapy is shown to induced glycemic remission, but traditionally patients were hospitalized for 2-4 weeks in order to receive the therapy, the long inpatient period precluded the wide application of the thrapy. This study aims to invesitgate whether simplified regimen is non-inferior to traditional regimen in achieving long-term glycemic remisson.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-sen University
• Treatments: Insulin; Insulin, Globin Zinc

Criteria

Inclusion Criteria:

• newly diagnosed type 2 diabetes with no prior hypoglycemic agents application, or on hyperglycemic monotherapy for less than 1 week;

• GHbA1c ≥ 9%

• Body mass index between 20-35kg/m2

• Capable to use wearable devices and mobile Apps;

• willling to follow the study protocol and data collection.

Exclusion Criteria:

• Type 1 diabetes or specific types of diabetes;

• Allergic or intolercance to medicine used in the study;

• Acute diabetic complications (diabetic ketoacidosis, hyperosmotic hyperglycemia coma or lactic acidosis);

• Severe diabetic microvascular complications (proliferative retinopathy, clinical proteinuria,uncontrolled diabetic neuropathy and obvious diabetic autonomic neuropathy;

• Glomerular filtration rate less than 50 ml/min

• ALT >2.5 times of the upper limit of normal (ULN), or bilirubin > 1.5 times of ULN；

• Significant Macrovascular disease:acute cerebrovascular accident, acute coronary syndrome or peripheral artery disease that required vascular intervention or amputation 12 months before enrollment;

• Poor blood pressure control (systolic blood pressure≥180mmHg and/or sitting diastolic blood pressure ≥110mmHg) and unable to control under 160/110mmhg within 1 week;

• Hemoglubin level < 100g/L or required regular blood transfusion;

• Chronic cardiac dysfunction with NYHA grade III or above;

• Use of medicines that affect blood glucose for a cumulative time of more than 1 week within the prior 12 weeks, such as oral/venous glucocorticoid, growth hormone, estrogen/ progesterone, high-dose diuretics, antipsychotic drugs. However, low-dose diuretics for antihypertensive purposes (HCTZ < 25mg/d, indapamide < 1.5mg/d) and physiologic replacement of thyroid hormone are allowed;

• Serious systemic disease or malignant tumor, chronic diarrhea, etc；

• Uncontrolled abnormalty in endocrine glands (Cushing's syndrome, hyperthyroidism, etc.);

• Any factors that may affect the participation of the subject in the study or the evaluation of the results；

• Pregnancy or planned pregnancy, lactation subjects.