NCT03972982

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

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.

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 330 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2019-06-01
• Primary completion: 2021-12-31
• Completion: 2022-12-31
• First posted: 2019-06-04
• Last updated: 2019-06-04

Locations

1 site across 1 country: China