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Regimen Transition After Short-Term Intensive Insulin Therapy in Type 2 Diabetes

NCT07173712 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 324

Last updated 2026-02-06

No results posted yet for this study

Summary

Failure of oral antidiabetic drugs (OADs) is a frequent challenge in patients with type 2 diabetes mellitus (T2DM), and inadequate long-term glycemic control substantially increases the risk of diabetic complications. Short-term intensive insulin therapy (SIIT) is an established approach to mitigate glucotoxicity; however, the optimal strategy to sustain long-term glycemic benefits after SIIT in T2DM patients with OAD failure remains unclear. To address this gap, we designed a randomized controlled trial to evaluate subsequent treatment options, aiming to identify a simple and effective regimen for patients with poor glycemic control who undergo SIIT.

A total of 324 eligible patients will be enrolled. After screening, previous antidiabetic regimens will be discontinued, and patients will be randomly assigned to the SIIT- iGlarLixi group (A), the SIIT-IDegAsp group (B), or the SIIT-iGlar group (C). All patients will be hospitalized for short-term insulin pump therapy, followed by 24 weeks of treatment: group A with insulin glargine/lixisenatide, group B with insulin degludec/aspart, and group C with insulin glargine U300 plus metformin. During the extension follow-up period, patients in all groups may either continue their assigned regimen or return to their original pre-study therapy. A total of 10 clinic visits are scheduled for each patient throughout the study.

Primary endpoint is proportion of patients achieving glycosylated hemoglobin A1C \<7% at 24 weeks.Secondary endpoints include proportion of patients achieving glycosylated hemoglobin A1C \<6.5% at 24 weeks; differences in weight gain, hypoglycemic events among treatment groups, and differences in proportion of patients continuing the assigned regimen, glycemic control and body weight at the extension follow-up period.

Conditions

Interventions

DRUG

CSII

Short term intensive insulin therapy

DRUG

Insulin glargine /lixisenatide Fixed Ratio Combination

Insulin Glargine and Lixisenatide Injection(I) Treatment for 24 weeks

DRUG

Insulin Degludec and Insulin Aspart Injection

Insulin Degludec and Insulin Aspart Injection Treatment for 24 weeks

DRUG

Insulin Glargine (HOE901 - U300)

Insulin Glargine Treatment for 24 Weeks

DRUG

Metformin

Metformin Treatment for 24 weeks

Sponsors & Collaborators

  • Yanbing Li

    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
2026-03-15
Primary Completion
2027-06-30
Completion
2027-12-31

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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 NCT07173712 on ClinicalTrials.gov