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

Phase 4

• Conditions: Glycemic Remission; Newly Diagnosed Type 2 Diabetes; Simplified Short-term Intensive Insulin Therapy
• Interventions: Drug: Traditional Short-term Intensive insulin therapy; Drug: Simplified intensive insulin therapy regimen

• Registration Number: NCT03972982
• Lead Sponsor: Sun Yat-sen University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-06
• Study Start: 2019-06-01
• Study First Submitted: 2019-06-01
• Study First Submitted QC: 2019-06-01
• Last Update Submitted: 2019-06-01
• Study First Posted: 2019-06-04
• Last Update Posted: 2019-06-04
• Primary Completion: 2021-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 330

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Routine group	Traditional Short-term Intensive insulin therapy	Inpaitent short-term continuous subcutaneous insulin infusion will be administered to maintained euglycemia for 2 weeks, Then subjects will be follow-up routinely.
Simplified regimen group	Simplified intensive insulin therapy regimen	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.

Primary Outcome Measures

Name	Time	Method
remission rate	24 weeks after withdrawal of the medical intervention	Remission is defined as fasting plasma glucose less than 7mmol/L and GHbA1c less than 7% without any hypoglycemic agents

Trial Locations

Locations (1)

endocrinology department of the first affiliated hospital of Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China