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出境医 / 临床实验 / Effects of Structured Simplified Short-term Intensive Insulin Therapy on Long-term Glycemic Remission

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

Study Description
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.

Condition or disease Intervention/treatment Phase
Newly Diagnosed Type 2 Diabetes Simplified Short-term Intensive Insulin Therapy Glycemic Remission Drug: Simplified intensive insulin therapy regimen Drug: Traditional Short-term Intensive insulin therapy Phase 4

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 330 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Estimated Study Start Date : June 1, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2022
Arms and Interventions
Arm Intervention/treatment
Experimental: 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.
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.

Active Comparator: 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.
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

Outcome Measures
Primary Outcome Measures :
  1. remission rate [ Time Frame: 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


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

Locations
Layout table for location information
China, Guangdong
endocrinology department of the first affiliated hospital of Sun Yat-sen University
Guangzhou, Guangdong, China, 510080
Sponsors and Collaborators
Sun Yat-sen University
Tracking Information
First Submitted Date  ICMJE June 1, 2019
First Posted Date  ICMJE June 4, 2019
Last Update Posted Date June 4, 2019
Estimated Study Start Date  ICMJE June 1, 2019
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 1, 2019)
remission rate [ Time Frame: 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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Structured Simplified Short-term Intensive Insulin Therapy on Long-term Glycemic Remission
Official Title  ICMJE 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.
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Newly Diagnosed Type 2 Diabetes
  • Simplified Short-term Intensive Insulin Therapy
  • Glycemic Remission
Intervention  ICMJE
  • 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.
  • 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
Study Arms  ICMJE
  • Experimental: 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.
    Intervention: Drug: Simplified intensive insulin therapy regimen
  • Active Comparator: 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.
    Intervention: Drug: Traditional Short-term Intensive insulin therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: June 1, 2019)
330
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2022
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03972982
Other Study ID Numbers  ICMJE 2018YFC1314102
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Yanbing Li, Sun Yat-sen University
Study Sponsor  ICMJE Sun Yat-sen University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Sun Yat-sen University
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP