Clinical trial NCT03972982: 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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Newly Diagnosed Type 2 Diabetes
Simplified Short-term Intensive Insulin Therapy
Glycemic Remission
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2019-06-04
Enrollment: 330
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: remission rate
timeFrame: 24 weeks after withdrawal of the medical intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: endocrinology department of the first affiliated hospital of Sun Yat-sen University
state: Guangdong
Study officials:
References: