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

NCT ID: NCT03972982

Last Updated: 2019-06-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 330 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-01
• Study Completion Date: 2022-12-31

Brief 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.

Conditions

Newly Diagnosed Type 2 Diabetes; Simplified Short-term Intensive Insulin Therapy; Glycemic Remission

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Simplified regimen group

Short-term continuous subcutaneous insulin infusion will be adminstrated to maintained euglycemia for 1 week，Then subsequent therapy using basal insulin plus metformin will be administrated. After withdrawal of the medicine, wearable devices and smart apps will be used for long-term management.

Group Type: EXPERIMENTAL

Simplified intensive insulin therapy regimen

Intervention Type: DRUG

Short-term continuous subcutaneous insulin infusion to maitain near normoglycemica for 1 week, thereafter basal insulin and metformin were subsequently used. Wearable devices and smart apps will be used for lifestyle modification.

Routine group

Inpaitent short-term continuous subcutaneous insulin infusion will be administered to maintained euglycemia for 2 weeks, Then subjects will be follow-up routinely.

Group Type: ACTIVE_COMPARATOR

Traditional Short-term Intensive insulin therapy

Intervention Type: DRUG

Short-term continuous subcutaneous insulin infusion will be initiate to maitain near normoglycemica for 2 weeks, then patients will be ordinarily follow-up

Interventions

Simplified intensive insulin therapy regimen

Short-term continuous subcutaneous insulin infusion to maitain near normoglycemica for 1 week, thereafter basal insulin and metformin were subsequently used. Wearable devices and smart apps will be used for lifestyle modification.

Intervention Type: DRUG

Traditional Short-term Intensive insulin therapy

Short-term continuous subcutaneous insulin infusion will be initiate to maitain near normoglycemica for 2 weeks, then patients will be ordinarily follow-up

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Yanbing Li

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

endocrinology department of the first affiliated hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Countries

China

Other Identifiers

2018YFC1314102

Identifier Type: -

Identifier Source: org_study_id