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

NCT03972982 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 330

Last updated 2019-06-04

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Sun Yat-sen University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-01
Primary Completion
2021-12-31
Completion
2022-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03972982 on ClinicalTrials.gov