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

Newly Diagnosed Type 2 Diabetes Clinical Trial

Official title:

Induction of Long-term Glycemic Remission Via Structured Simplified Short-term Intensive Insulin Therapy in Patients With Newly Diagnosed Type 2 Diabetes: a Multiple Centered, Randomised Controlled Trial.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03972982
• Other study ID #: 2018YFC1314102
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: June 1, 2019
• Est. completion date: December 31, 2022

Study information

• Verified date: June 2019
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 330
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Glycemic Remission
• Newly Diagnosed Type 2 Diabetes
• Simplified Short-term Intensive Insulin Therapy

Intervention

Drug:
• 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.
• 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

Locations

Country	Name	City	State
China	endocrinology department of the first affiliated hospital of Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	remission rate	Remission is defined as fasting plasma glucose less than 7mmol/L and GHbA1c less than 7% without any hypoglycemic agents	24 weeks after withdrawal of the medical intervention