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Impact of Short-term Intensive De-escalation Therapy on Long-term Regimen Simplification

NCT03958591 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 274

Last updated 2026-05-13

No results posted yet for this study

Summary

Despite advances in diabetes management, many patients with type 2 diabetes in China fail to achieve optimal glycemic control. One of the possible reasons is associated with the delay in therapeutic decision making that lags behind glycemic rise. The investigators design this study and presume that using vildagliptin and metformin in combination with basal insulin as sequential treatment after intensive insulin therapy, might better modulate the dual islet hormone dysfunction than traditionally stepwise upgrading therapy pattern in patients with poorly controlled T2DM, and thus lead to a glucose normalization, β-cell function improvement and therapy simplification.

Conditions

  • Diabetes type2

Interventions

DRUG

CSII and thereafter combination therapy, followed up with wearable devices

Short-term continuous subcutaneous insulin infusion and thereafter the combination therapy of basal insulin, metformin and vildagliptin; Wearable devices will be used to manage and follow-up the participants.

DRUG

CSII and thereafter combination therapy

Short-term continuous subcutaneous insulin infusion and thereafter the combination therapy of basal insulin, metformin and vildagliptin.

DRUG

Basal insulin treatment without wearables

The participants will be applied the combination therapy of basal insulin, metformin and vildagliptin for the entire 12 weeks.

Sponsors & Collaborators

  • Yanbing Li

    lead OTHER

Principal Investigators

  • Yanbing Li, Dr · FAH-SYSU

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
2019-05-01
Primary Completion
2025-01-01
Completion
2026-03-31

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 NCT03958591 on ClinicalTrials.gov