search
Back to results

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

Primary Purpose

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

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Simplified intensive insulin therapy regimen
Traditional Short-term Intensive insulin therapy
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Newly Diagnosed Type 2 Diabetes

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Simplified regimen group

Routine group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

remission rate
Remission is defined as fasting plasma glucose less than 7mmol/L and GHbA1c less than 7% without any hypoglycemic agents

Secondary Outcome Measures

Full Information

First Posted
June 1, 2019
Last Updated
June 1, 2019
Sponsor
Sun Yat-sen University
search

1. Study Identification

Unique Protocol Identification Number
NCT03972982
Brief Title
Effects of Structured Simplified Short-term Intensive Insulin Therapy on Long-term Glycemic Remission
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.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2019 (Anticipated)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Newly Diagnosed Type 2 Diabetes, Simplified Short-term Intensive Insulin Therapy, Glycemic Remission

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
330 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Simplified regimen group
Arm Type
Experimental
Arm Description
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.
Arm Title
Routine group
Arm Type
Active Comparator
Arm Description
Inpaitent short-term continuous subcutaneous insulin infusion will be administered to maintained euglycemia for 2 weeks, Then subjects will be follow-up routinely.
Intervention Type
Drug
Intervention Name(s)
Simplified intensive insulin therapy regimen
Intervention Description
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
Intervention Name(s)
Traditional Short-term Intensive insulin therapy
Intervention Description
Short-term continuous subcutaneous insulin infusion will be initiate to maitain near normoglycemica for 2 weeks, then patients will be ordinarily follow-up
Primary Outcome Measure Information:
Title
remission rate
Description
Remission is defined as fasting plasma glucose less than 7mmol/L and GHbA1c less than 7% without any hypoglycemic agents
Time Frame
24 weeks after withdrawal of the medical intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
endocrinology department of the first affiliated hospital of Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs