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

NCT03972982 | Unknown Phase 4

• 1 other identifier: 2018YFC1314102
• Study Type: interventional
• Target: 330
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Simplified regimen group

EXPERIMENTAL

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.

Drug: Simplified intensive insulin therapy regimen

Routine group

ACTIVE COMPARATOR

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

Drug: Traditional Short-term Intensive insulin therapy

Interventions

Simplified intensive insulin therapy regimen 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.

Simplified regimen group

Traditional Short-term Intensive insulin therapy DRUG

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

Routine group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

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

Guangzhou, Guangdong, 510080, China

Location

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 1, 2019
• First Posted: June 4, 2019
• Study Start: June 1, 2019
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2022
• Last Updated: June 4, 2019

Record last verified: 2019-06

Locations

CN (1)